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NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)

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The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Mental disorders constitute an immense burden on the U.S. population, with major depression now the leading cause of disability in the U.S., and schizophrenia, bipolar disorder, and obsessive-compulsive disorder ranked among the ten leading causes of disability. NIMH also takes a leading role in understanding the impact of behavior on HIV transmission and pathogenesis, and in developing effective behavioral preventive interventions. The NIMH conducts a wide range of research, research training, research capacity development, as well as public information outreach and dissemination to fulfill its mission. For additional information about areas of interest to the NIMH, please visit our home page at http://www.nimh.nih.gov. NIMH-Supported Program Announcements: (if the program announcement has expired, please contact Dr. Margaret Grabb for information on new opportunities, and also see: http://www.nimh.nih.gov/research-funding/small-business/small-business-program-announcements-issued-by-nimh.shtml) 1. Lab to Marketplace: Tools for Brain and Behavioral Research (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-071.html 2. Competing Renewal Awards of SBIR Phase II Grants for Brain and Behavior Tools (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html 3. Innovations in Biomedical Computational Science and Technology (SBIR) http://grants.nih.gov/grants/guide/pa-files/PAR-09-220.html 4. Development of PET and SPECT ligands for brain imaging (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-137.html 5. Pharmacologic Agents and Drugs for Mental Disorders (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-142.html Also see: http://grants.nih.gov/grants/guide/notice-files/NOT-MH-09-008.html. 6. Development of Biomarkers for Mental Health Research and Clinical Use (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-09-045.html 7. Probes for Microimaging the Nervous System (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-09-062.html. 8. High Throughput Tools for Brain and Behavior http://grants.nih.gov/grants/guide/pa-files/PA-08-001.html (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-002.html (STTR). 9. Bioengineering Nanotechnology Initiative (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-09-267.html 10. Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-10-081.html 11. Tools to Mitigate and Understand the Mental Health Effects of National Disasters (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-09-117.html 12. Manufacturing Processes of Medical, Dental, and Biological Technologies (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-09-113.html 13. Computational Tools for Research in Neuroscience, Behavioral Science and Mental Health http://grants.nih.gov/grants/guide/pa-files/PA-07-424.html (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-07-423.html (STTR) 14. Probes and Instrumentation for Monitoring and Manipulating Nervous System Plasticity (SBIR) http://grants.nih.gov/grants/guide/pa-files/PA-08-146.html 15. Robotics Technology Development and Deployment [RTD2] (SBIR) http://grants.nih.gov/grants/guide/pa-files/PAR-10-279.html Phase IIB Competing Renewal Awards See http://grants.nih.gov/grants/guide/notice-files/NOT-MH-09-008.html and http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html. The NIMH will accept Phase IIB SBIR Competing Renewal grant applications in two categories: 1) to continue research and development of technologies that ultimately require federal regulatory approval (see below and see http://grants.nih.gov/grants/guide/notice-files/NOT-MH-09-008.html, and 2) to continue research and development of complex instrumentation, clinical research tools, or behavioral interventions and treatments (see below and see funding opportunity announcement PA-08-056, entitled “Competing Renewal Awards of SBIR Phase II Grants for Brain and Behavior Tools (R44)” http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html. Technologies in the former category (those that ultimately require federal regulatory approval) include, but are not limited to: pharmacologic agents and drugs, biological products, medical devices, vaccines, etc., related to the mission of the NIMH. Phase IIB SBIR Competing Renewal grants for such technologies should allow small businesses to get research and development to a stage where interest and investment by third parties is more likely. Companies engaging in drug development for the treatment of mental health disorders may be eligible to submit Competing Renewal applications through the specific funding opportunity announcement PA-08-142 entitled “Pharmacologic Agents and Drugs for Mental Disorders (SBIR [R43/R44])” http://grants.nih.gov/grants/guide/pa-files/PA-08-142.html. For this specific opportunity, budgets up to $1.0 million total costs per year and time periods up to three years may be requested. Companies that are developing technologies that do not focus on drug development, but that require federal regulatory approval prior to commercialization, may be eligible to submit a Phase IIB Competing Renewal application through the standard SBIR funding opportunity announcement. For this opportunity, budget limits of up to $800,000 total costs per year and time periods up to 3 years may be requested. Please contact your Program Director or Dr. Margaret Grabb (contact information provided below) before beginning the process of putting an application together. In addition, prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information: • Descriptive title of the proposed research • Name, address, and telephone number of the Principal Investigator • Names of other key personnel • Participating institutions • Funding Opportunity Announcement Number (e.g., PA-10-XXX) Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NIMH SBIR Phase II awards will be eligible for a Phase IIB Competing Renewal grant. The following examples would make appropriate topics for proposed NIMH SBIR Phase IIB Competing Renewal projects. These are meant for illustrative purposes only and are not exclusive of other appropriate activities: • Preclinical studies, including pharmacology and toxicology, beyond those conducted under the Phase I (R43) and initial Phase II (R44) grants. Some in vivo or in vitro studies would be expected to have been carried out in Phase I or the initial Phase II grant. • Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application. • Studies in normal healthy volunteers to determine a drug’s safety profile, metabolism, etc. • Clinical studies in patient/disease population to assess the drug’s effectiveness. • Assessment of devices with regard to performance standards related to the FDA approval process. • Safety and effectiveness studies of novel medical devices. • Evaluation of novel imaging approaches for diagnostic purposes. • Clinical studies in support of Pre-Market Approval for biomarkers/medical devices by the FDA. Although technologies in the latter category (complex instrumentation, clinical research tools, or behavioral interventions/treatments) may not require federal regulatory approval, extraordinary time and effort is needed for their research and development. Therefore, NIMH supports Phase IIB Competing Renewal awards of existing Phase II grants for such technologies. The Phase IIB Competing Renewal award for these would provide up to an additional three years of support at total cost funding levels of up to $800,000 per year. Applicants should apply through the funding opportunity announcement PA-08-056, entitled “Competing Renewal Awards of SBIR Phase II Grants for Brain and Behavior Tools (R44)” http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html. Direct your questions about scientific/research issues to: Margaret Grabb, Ph.D. National Institute of Mental Health 6001 Executive Boulevard, Room 7201, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 (for express/courier service) Telephone: 301-443-3563 FAX: 301-443-1731 Email: mgrabb@mail.nih.gov Division of Neuroscience and Basic Behavioral Science Through research in neuroscience and basic behavioral science we can gain an understanding of the fundamental mechanisms underlying thought, emotion, and behavior and an understanding of what goes wrong in the brain in mental illness. Research sponsored by the Division of Neuroscience and Basic Behavioral Science covers a broad range of neuroscience topics: from both experimental and theoretical approaches, from molecules to whole brains to populations of individuals, from single cell organisms to humans, from across the entire lifespan, and from states of health and disease. This division also supports research on the basic behavioral, psychological, and social processes that underlie normal behavioral functioning. The topics listed below reflect the NIMH interest in technologies related to this broad range, but should not be considered a complete list. Prospective applicants are strongly encouraged to contact Dr. Margaret Grabb (listed below) with questions about the relevance of their interests to the mission of this division. A. Cutting-Edge Technologies for Neuroscience Research. Most of the research topics listed after this one are posed from the Division's neuroscience and basic behavioral science mission-oriented perspective, however, the technologies that might be developed to address those mission goals might be quite fundamental. Prospective applicants familiar with such technologies, but not familiar with the mission-related use of these technologies, are strongly encouraged to contact Dr. Margaret Grabb (listed below) for assistance in bridging this gap between their technical knowledge and knowledge of the neuroscience-related mission of NIMH. Technologies and approaches that might be used in products relevant to this mission include, but are not limited to: 1. Caged Molecules. These chemical entities could be activated, or could release an active agent, when specified bonds are broken by chemical, biochemical, photic, or other means. Among other uses, such molecules could be used to indicate biochemical or physiological processes or to deliver pharmacologic substances to highly localized brain regions. 2. Genetically Engineered Proteins. Such proteins could be put to any number of uses, including to express a fluorophore or chromophore at the occurrence of specific biochemical processes to report the time and location of such processes in brain tissue. 3. Inducible Gene Expression. Methods to turn on or off expression of particular genes in animals on the basis of time in the lifespan, location in the brain, or other factors. Such a capability would significantly advance basic brain research, and would have important implications for treatment and therapy of mental illness. 4. Combinatorial Approaches. These are high-through-put approaches that can be used to screen and synthesize molecules that affect brain cells. 5. Biocompatible Biomaterials. Such research and development relates to the chronic use of electrodes and other probes used in brain research, as well as implanted drug delivery devices. 6. Nanotechnologies. This emerging area of technology presents a wide range of opportunities for brain research, from the fabrication of probes to monitor brain physiology to novel means of delivering drugs and other substances. 7. Informatics Tools. Such technologies allow brain scientists, clinicians and theorists to make better sense and use of their data. These tools and approaches include those to acquire, store, visualize, analyze, integrate, synthesize and share data, including those for electronic collaboration. 8. Simulation Technologies. Computer-based, biologically realistic simulations of parts of neurons, neurons, and circuits. 9. Mathematical, Statistical and Computer Algorithms. Such algorithms could be used to analyze large and/or complex data sets. Examples of these data sets include those derived from multiple, single-unit recording studies and functional imaging studies. Among other applications, these could be used to segment images (obtained from electron or light microscopes, or from volumetric imaging instruments such as confocal microscopes and magnetic resonance imagers), filter noise, visualize data or search vast data sets for specified patterns or data (e.g., use of pattern recognition algorithms to search time series data sets obtained from electrophysiological recording of neural activity, or video data obtained from behavioral analysis of genetically altered animals). In addition, digital reconstruction of dendritic and axonal arbors would be of interest. 10. Telemetry. Transferring data from one point to another is important for neuroscientists monitoring the physiological signals from the brain. Telemetry, even over relatively short distances (from a few millimeters to a few meters), could, for example, provide a means to obtain data from awake, behaving animals without interfering with the behavior of interest. Examples include telemetry that can be easily implanted/attached to awake behaving animals for measuring peripheral/autonomic responses (this approach could be used to inform stress/emotion research), miniaturized telemetry for use in smaller animals with increased numbers of recording devices/electrodes implanted per animal. Alternatives to telemetry would be considered as well. 11. Biosensors. Neurons communicate with each other through thousands of different chemical substances; internally, molecular pathways direct the function of the neuron. Sensors of high specificity and sensitivity for such substances would provide neuroscientists with important new ways to study the brain. B. Instrumentation for Basic Neuroscience Research. Modern equipment that uses the most recent technological advances is needed in neuroscience research so that neural substrates of mental illness can be identified and localized. The NIMH is interested in supporting research and development of new or improved approaches relevant to, but not limited to, the following: 1. Neurophysiology. Microelectrodes for stimulation and/or recording, smart nanoscaffolds, macroelectrodes, biocompatible coatings, interfaces to electronics, software for data analysis, visualization, etc. Systems with better/easier MR compatibility would also be of interest. 2. Cell Sorting. Based on cell size, type, function, morphology, abnormal features, specific membrane proteins, etc. 3. In Vivo Electrochemical Voltammetry. More sensitive and selective electrodes, software for data analysis, etc. 4. High Performance Liquid Chromatography. Improved reliability, specificity, sensitivity, etc. 5. Technology to support Multiple Unit Recording Electrode Arrays. Recording techniques, analysis techniques and raw data storage. 6. Physiological and Behavioral Monitoring. Temperature, activity, sleep duration, neuronal activity, EEG activity, EKG, pulse rate, recording, capture and analysis of multiple single unit activity from microelectrodes, automated SWS analysis and coherence of EEG rhythms, and further refinement of High density EEGs. 7. Development of novel technologies for stimulating specific cells or signaling pathways in awake behaving animals. 8. Development of more sensitive fluorescent probes for simultaneous and real time measures of multiple neurotransmitter release and intracellular signaling pathway activities. 9. Associated Software. C. Macroscopic Neuroimaging. Modern technologies allow for the observation of the structure and function of the intact brain. This capability has the potential to greatly advance understanding of the brain in both health and disease, and across the lifespan. NIMH is interested in advancing this area of technology through enhancing current tools and approaches, as well as developing entirely new ways to image the brain. All modalities are of interest, including, but not limited to: magnetic resonance imaging (MRI) or spectroscopy, positron emission tomography (PET), optical imaging or spectroscopy, single photon emission computed tomography, magnetoencephalography (MEG), diffusion tensor imaging (DTI), etc. While not an imaging technique itself, transcranial magnetic stimulation (TMS) is an associated, important technology. TMS can be used in combination with fMRI as means to further assess physiology and integrity of neural systems both in health and in mental disorders. Due to its greatly increased use in recent years, technologies specifically focused on improving the utility and specificity of fMRI techniques are of particular interest. 1. Innovative agents and/or technologies to visualize brain connectivity, activity, and neural plasticity in situ with minimal invasion. 2. Improvement in the techniques, the design and construction of devices for non-invasive imaging for any modality, for example, improving spatial resolution, quantitative accuracy, signal-to-noise ratio, and electronics. 3. Development and enhancement of non-invasive imaging techniques for evaluating alterations in brain physiology produced by drugs. These would include techniques for monitoring changes in regional blood flow; concentrations of drug and/or tissue metabolites; and the distribution and activity of receptors. 4. Synthesis, or isolation from natural products, of highly selective receptor ligands or indicators of neurochemical processes, which would be labeled for imaging by one or more particular modality. 5. Development of selective hormone receptor ligands for brain imaging. 6. Development of imaging agents to examine the integrity of the blood brain barrier following infection and other environmental challenges. 7. New approaches in radiochemistry that will permit more exact identification of the chemical changes associated with behavioral states (e.g., sleep or arousal) or mental illness as observed with any particular neuroimaging modality. 8. Synthesis of molecules containing stable, rarely occurring isotopes designed to be detected by non-invasive imaging techniques (e.g., fluorine-containing molecules, carbon-13 labeled substrates). 9. Methods and associated products for quantification of imaging data including new statistical approaches for evaluating the data. 10. Methods to integrate routines for greater and more precise computer enhancement of the images, and for combining or overlaying images obtained from multiple modalities. 11. Software needed for the precise quantification of data obtained from these imaging techniques with emphasis on the reliable definition of discrete, anatomically distinct areas within the brain. 12. Novel agents or other tools to increase the ability to correlate features of MR images with histological features (e.g., cytoarchitecture or chemoarchitecture) both identified and those yet to be identified. 13. Generation of physiologic measurements from images of regional radioactivity generated during PET, especially for the study of brain neurotransmitter/neuroreceptor systems. 14. Novel approaches to visualizing data obtained in neuroimaging, such as the computational “unfolding” of three-dimensional images of cerebral cortex. 15. Improved methods for pediatric brain imaging. These would include: software and database products, equipment for creating a “child-friendly” environment and for the behavioral training of children and impaired subjects for cooperation and motion reduction during neuroimaging procedures. 16. Combining of different imaging technologies (e.g., ERPs and fMRI; MEG and fMRI; MEG and EEG, optogenetic methods and fMRI, etc.). The latter example, optfMRI, can be used as means of improving tools for further understanding of neural bases of fMRI signals and to produce connectivity a map of neural cells that can be defined both genetically and topographically with a combination of these two techniques. 17. New tools and devices to simultaneously record hemodynamic signals (BOLD, rCBF, etc.) and neural activity (EEG, LFP, spiking, etc.) to better understand the direct relationship between blood flow variables and neural activity within the brain. 18. Development of equipment, software and other tools for recording and quantifying eye movements, motion, and autonomic reactivity during scanning, applicable to all ages (including young children) particularly in the MRI environment. 19. Methods for relating changes in brain morphology and metabolism associated with age, particularly infancy through adolescence, to changes in hemodynamic responses to neural activity and fMRI signals. 20. Improvements in TMS techniques that will allow for greater specificity in the sites of stimulation and greater control over the effects of the stimulation. In particular, improvements in stimulators that would allow much smaller effective fields of stimulation with more reliable and repeatable stimulator placement would be a significant benefit to the field. 21. Real time fMRI is becoming a research tool of interest with potential clinical/therapeutic neurofeedback applications. Products are needed that would enhance the ability of scientists to use this technology for those neurofeedback applications in an off-the-shelf manner. 22. Development of methods to improve efficiency, specificity and controllability of viruses used in primate tract tracing studies. 23. Development of more sophisticated imaging strategies in rodents. 24. Development of a user-friendly interface to serial reconstruction software capable of generating stackable, 3D images of axonal and dendritic arborizations at the light and electron microscopic level. D. Microscopic Neuroimaging. The morphology of individual neurons and the distribution of subcellular components within them, are key to understanding the manner in which these cells function. Advances in the development of agents indicating neuronal structure and function that can be visualized microscopically are important to the NIMH's interest in brain research. This includes enhancements of current agents and ligands to be imaged (agents indicating specific biochemical processes or structures, etc.); development of novel agents and ligands; software to assist interaction with the data; and other related technologies and methods. Examples would include, but not be limited to: 1. Software and hardware for analyzing image data obtained by microscopes, including tools to automatically or semi-automatically. Identify particular profiles (e.g., labeled cell bodies), segment images, reconstruct images into three dimensional representations, perform unbiased counting and measuring, etc. 2. Synthesis and testing of novel or improved probes for microimaging the nervous system. E. Molecular and Cellular Neurobiology and Neurochemistry. Manipulating and studying basic molecular, cellular and chemical processes has led to insight to understanding brain function, and has provided the foundation on which pharmacological interventions have been developed for the treatment of mental illness. NIMH is interested in supporting a wide range of new techniques and tools related to this area. These include, but are not limited to: 1. New low-cost techniques for hybridoma production of monoclonal antibodies specific for “neural antigens” (e.g., neurotransmitters, small peptides, neurotransmitter receptors). 2. Innovative methods for establishing a “monoclonal bank” (frozen cells) for each of the cell lines as a permanent, widely available, reliable, and low cost source of monoclonal antibodies for research on the nervous system. 3. Labeled antibodies or other agents that will readily identify receptors for which there are no ligands (orphan receptors) and which have low densities in the brain. 4. Automated methods for quantifying the low levels of bound ligands for quantifying receptors that are sparsely scattered in the brain. 5. New cell lines that express each of the known neurotransmitter receptors so that each cell line will be homogeneous for one receptor. 6. New cell lines that express each of the above receptors linked to some metabolic function and/or second messenger so that the functional consequences of receptor occupancy can be detected. 7. High volume, inexpensive assay methods for measuring both receptor occupancy and cellular response for each of the receptor types. 8. Develop cell culture models for neurons, including methods of purifying homogeneous populations of non-transformed cells by, for example, developing markers to identify neuronal cell types for use in characterizing cell-type-specific signaling pathways which may be useful in tracking the effects of various drugs. 9. Develop techniques for either activating or deactivating specific ion channels, receptors and signal transduction pathways. 10. Develop dynamic biochemical and imaging assays that allow measurement of variables now obtained only through electrophysiological techniques. 11. Develop tools to facilitate proteomic analysis of CNS neurons. 12. Develop tools to facilitate in vivo studies of protein-protein interaction, folding and aggregation. These technologies could impact our understanding of the basic neurotransmitter receptors chemistry and on developing of more selective small chemical entities with high affinities for CNS targets. 13. New approaches to study the multiple functions of particular proteins. 14. Tools to study post-translational changes in proteins (expression levels, post-translational modifications, etc.) in specified tissue compartments and subcellular domains. 15. Technologies to study functional entities within cells (e.g., green fluorescent protein approaches) and subcellular compartments. 16. Tools and approaches to study coordinate changes in genes and their functional relationship to phenotypes, including phenotypes associated with specific brain disorders. 17. Novel tools and approaches to study protein-protein interactions, especially those with phosphoproteins. Further develop methods and reagents for studying the structures of membrane proteins at atomic resolution. Membrane protein systems that are of particular interest to NIMH include proteins involved in normal function and pathology of cells (neurons and glia) in the central and peripheral nervous system. 18. Develop novel techniques for isolating and identifying the structure of brain-derived membrane proteins. 19. New methods to identify peptide receptors for which traditional biochemical approaches (e.g.: radiolabeling techniques) failed to produce results. This would be relevant for the development of small molecular probes that would target peptide systems that might be altered in mental disorders. 20. Development of new and optimization of the existing methods for non-invasive quantitative detection of hormones and hormone action in awake behaving animals. 21. Development of novel technologies to adapt human induced pluripotent stem cells (iPSCs) to identify molecular and cellular dysfunction underlying mental illness and for high throughput screening assays for candidate therapeutics. 22. Continuing to improve optogenetic techniques (combining optical and genetic techniques to probe neural circuits within intact animals). F. Genetic and Transgenic Technology. Advances in genetic and transgenic technologies offer many opportunities to probe fundamental questions about the brain, behavior and pathology. NIMH is broadly interested in these areas; some examples of topics relevant to the mission of this Institute include, but are not limited to: 1. Methods to perform site-directed mutagenesis in cell lines for the study of membrane proteins such as ion channels and neurotransmitter receptors. 2. Development of gene “knockout” or “knockin” animals using such approaches as homologous recombination targeting genes important in neurotransmission, development, and tropic interactions as well as models relevant to psychiatric disease. 3. New methods to delete or alter targeted genes in the preparation of transgenic animals including methods that increase or decrease gene expression. 4. Development of new techniques and apparatus for delivery of synthetic nucleic acids to manipulate endogenous gene expression in specific cell populations and/or brain regions. 5. Develop and validate standardized behavioral tests and apparatuses to assess the gene knockouts and/or gene “knockins” affecting neurotransmission. 6. New approaches for spatially and/or temporally restricted gene activation and/or inactivation. 7. Develop novel markers for elucidating how signaling cascades impact DNA transcription. 8. New ways to assess quantitatively transcription of genes in real time in a manner that is minimally injurious to cells (e.g., non-permeabilizing approaches). 9. Develop new technologies to study gene function and expression, including approaches to studying gene and protein expression at single cell resolution. 10. Develop novel approaches to study the expression characteristics of non-coding (nc) RNA molecules as well as developing methodologies using nc-RNAs to manipulate gene expression in cells and tissues of the nervous system. 11. Development of embryonic stem (ES) cell lines from rodent strains (rats and mice) of relevance to behavioral research. 12. Development of technologies and approaches to facilitate the collection and distribution of ES cell lines containing mutations of potential relevance to behavioral and neural processes relevant to neuropsychiatric disorders. 13. Develop methods for long-term storage of transgenic germ cell lines. 14. Develop technologies and approaches to aid in the renewal of founder colonies of transgenic mice from repositories of transgenic germ cell lines. 15. Develop databases on neurobiological transgenic animals produced to date, including information such as the origin of the transgenic animal, key features of the biological and behavioral mutant, availability and location of germ cell lines, and existence of breeding colonies. 16. Develop gene transfer technologies such as viral vectors and non-viral (e.g. polymer-based) systems to produce long-term, stable gene expression in the brain. 17. Develop methods to analyze and manipulate DNA structure to study epigenetic modifications and chromatin remodeling in brain tissue and neuronal populations. 18. Development of selective gene silencing strategies to ablate neurons in one circuitry in order to examine its specific behavioral consequences. 19. Technology development in epigenetics: a) development of novel and highly accurate tools to analyze proteomics of histones b) development of antibodies for immunochemical studies of histone modifications that selectively target a specific DNA modification site c) develop and apply tools for epigenetic research to determine how, when, and where experience affects gene expression. 20. Technology development in Microbiome research: a) development of tools for high throughput genomic analysis of human microbiome; b) development of informatics tools to study the huge amount data that will result from these studies; and c) development of methods to determine the interaction between microbial community genes and host genetics as a potential contributing factor for mental disorders. G. Neuroimmunology. Research on the interplay between the brain, neuroendocrine system, and, immune system has revealed important links between these major homeostatic system components. Examples of NIMH-relevant topics in this area include, but are not limited to: 1. Development of new tools to explore the specific properties of the blood-brain barrier responsible for the selective delivery or retention of cytokines, immune cells, and drugs affecting immune activity in the brain. 2. Development of assays for identifying potential autoimmune components of psychiatric disorders. 3. Identification of critical molecules, processes, and pathways mediating signals from the peripheral immune system to the brain. 4. Development of novel cytokine ligands and antagonists, and neuroimaging agents. H. Pharmacology. Pharmacological intervention represents a major force in the treatment of mental illness, and NIMH is interested in supporting research and development in this area. However, pharmacologic agents that primarily act on molecular targets which replicate those of currently-marketed pharmaceuticals used in the treatment of mental disorders would not be of interest for this program. Relevant pharmacology topics include, but are not limited to: 1. New chemical entities with high, selective affinities for CNS targets. Examples include, but are not limited to, receptors, transporters, ion channels, enzymes, kinases, or second or third messenger systems. 2. Methods to evaluate old and new chemical entities (including complex mixtures of crude extracts from natural products) for possible therapeutic usefulness using “in vitro” and “in vivo” assays and model systems. 3. Methods for extraction, fractionalization, and isolation of active compounds from natural products. Water-soluble compounds are of particular interest due to the difficulty of the procedures. 4. Computer algorithms that model receptors to evaluate theoretical permutations of known molecules to find the molecule with the maximum probability of having the highest affinity for a specific receptor as well as those that have the potential for the most desirable “on” and “off” rates. 5. Computer models of the blood brain barrier and evaluate potential and actual drug molecules for their ability to cross or penetrate this barrier. 6. Strategies for evaluating pharmacological agents (e.g., animal behavioral testing, computer simulation) within specific domains of cognitive function. 7. Behavioral “models” similar in animals and humans; behavioral pharmacological effects that may serve as “surrogate” markers in humans. 8. Development of models for evaluating drug effects within functional brain circuits relevant to mental disorders. 9. Development of novel drug delivery systems. 10. Tools for Drug Development including neuroimaging (e.g., radiolabeled compounds) and development of animal models. 11. Pharmacological profiling (in vitro and in vivo) for potential therapeutic drugs. 12. Methods for evaluation of long-term effects of psychotropic drug administration in animal models or human subjects. If clinical populations are being tested, the technology would be appropriate for either the Division of Developmental Translational Research (DDTR) or the Division of Adult Translation Research (DATR) at NIMH. 13. Improving existing, and developing new, vectors for delivery of genes to the brain. 14. Development of novel therapeutic approaches targeting gene expression through effects on promoter activity or epigenetic mechanisms. 15. Development of novel high throughput screening (HTS) assays for drug development. Examples include, but are not limited to, in vitro functional assays, toxicology screens, blood-brain barrier permeability assays, and circuit based or behavioral assays. 16. Development of novel molecular targets for drug development to treat mental illnesses. I. Tract Tracing Methods and Tools. Little is known about the details of the connectivity of the human nervous system, because the best tract tracing techniques are invasive and require the deposit of substances in vivo. Methods that would be applicable to post-mortem tissue would allow significant progress in connectional studies of human tissue, as well as non-human tissue, particularly with regard to the development of c, quantu onnections and the connections of structures not easily accessed in vivo. Examples include the development of improved physical, chemical and/or biological markers for neuroanatomical tract-tracing (e.g. m dots, caged molecules, viral delivery agents, etc.). J. Educational Tools. Neuroscience, basic behavioral science and human genetics are compelling areas of science that not only touch upon a diverse array of disciplines, but also provide insights to the essence of what it is to be human. Products aimed at teaching the substance of these fields to students of all ages would be useful in disseminating this information and these insights. Examples include, but are not limited to: software and other interactive media used to convey fundamental concepts about the brain to children; computer simulations of neuroscience experiments; updateable media that presents state-of-the-art information on particular topics for use by experts; website or other online, interactive electronic vehicle to allow for sharing of information about the brain and its functions, including technologies for holding interactive research conferences related to basic behavioral sciences, basic neuroscience, or clinical neuroscience. K. Neuroinformatics. Data generated by brain research are diverse, vast, and complex. The diversity of data is due to the fact that neuroscience data are obtained from: theoretical, experimental and clinical approaches; from levels of biological organization that span molecules to populations of individuals and from single-cell organisms to humans; and from states of health, disease, and models of disease. The quantity of data in brain research is the result of tens of thousands of neuroscience laboratories working around the world. The complexity of data reflects the high level of interconnectedness of the data, and their high dimensionality. Neuroinformatics is a new area of science that draws upon neuroscience, information science, computer science, statistics, applied mathematics, and a variety of engineering fields to develop tools that will let neuroscientists make better sense and use of their data. These tools include software and hardware for digital data acquisition, visualization, analysis, integration, and sharing (e.g., through tools for electronic scientific collaboration). Such tools can address data of any type or from any area of neuroscience; examples include, but are not limited to: 1. Databases, querying approaches, and information retrieval tools for neuroscience and neuroscience-related data. An example would be the development of a web-based database for sharing, analyzing and comparing the pharmacological responses of a variety of CNS active compounds in preclinical studies relevant to mental health. 2. Tools for neuroscience data visualization (and other forms of presentation) and manipulation (probabilistic atlases of brain structure or function, new statistical approaches for analyzing data, etc.). 3. Software for integration and synthesis of neuroscience data (computational models of neurons to integrate data about structure and function, environments to merge data from multiple imaging modalities, etc.). 4. Tools for electronic collaboration to allow neuroscientists to interact with colleagues, data, and instruments at a distance (this could include novel types of “groupware”, etc.). 5. Tools that bridge existing neuroscience and biology information tools and resources, such as databases and informatics tools associated with genome mapping efforts. For further information on basic neuroscience or basic behavioral science research topics, contact: Margaret Grabb, Ph.D. National Institute of Mental Health 6001 Executive Blvd. Room 7201 Mail Stop Code 9645 Bethesda, MD 20892 301-443-3563, Fax: 301-443-1731 Email: mgrabb@mail.nih.gov The Division of Developmental Translational Research The Division of Developmental Translational Research directs, plans, and supports programs of research and research training leading to the prevention and cure of childhood psychopathology. This long-term goal will be accomplished through an integrated program of research across behavioral/psychological processes, brain development, environment and genetics. The topics listed below reflect the NIMH interest in technologies related to this research area, but should not be considered a complete list. Prospective applicants are strongly encouraged to contact Dr. Margaret Grabb (listed below) with questions about the relevance of their interests to the mission of this division. A. Technologies for Clinical Pediatric Research. It is important to develop reliable methods that can correctly identify the normal and abnormal components of cognitive, emotional, and psychosocial behavior, as well as normal and abnormal physiological and biochemical functions, in human development. Computer-based methods of accomplishing this are also needed to increase the accessibility and reliability of information made available to the research community. Examples include: 1. Measurements of Alterations in Pediatric Development in Patients with Mental Health Disorders Using Physiological and Behavioral Measures. Research studies indicate that some mental health disorders, such as autism, may begin to develop as early as infancy. Therefore non-invasive modern equipment that use the most recent technological advances are needed to isolate specific physiological and behavioral changes during development, to identify potential diagnostic markers of mental health disorders. A priority for this program is to support research and development of hardware and software tools to measure pediatric development. Examples of technologies needed include: a. Psychophysiological measures to evaluate infants, children or adolescents. b. Miniaturized non-invasive instruments to record psychophysiological data (e.g., heart and respiration rate, galvanic skin response, and defensive motor behavior). c. Telemetry capability for non-invasive devices so that children can be monitored for prolonged periods without interfering with their behavior. d. Computer programs and inexpensive computers that will collect, analyze and identify recurring patterns in the psychophysiological measure(s) of interest. 2. Pediatric Assessment Tool. Diagnosis of mental health disorders in children and adolescents is vital to providing early interventions to treat the disorder. In addition, a better understanding of the concept of functioning in psychopathology, and its appropriate measurement, is needed in pediatric populations. In the future, diagnostic tools may even help detect the initial onset of illness in children at risk, before symptoms occur. A priority for this program is to develop novel diagnostic tools to detect mental health disorders in children and adolescents. Of particular interest to this division are methods that can be used with children and adolescents with limited verbal communication (i.e., very young or developmentally disabled). Biochemical, genetic, physiological and psychological tool development is welcomed. a. Technologies to assess CNS effects of psychosocial or pharmacological interventions. b. Development of reliable and stable biomarkers/biosignatures that can identify at-risk individuals prior to disease onset, biological and behavioral indicators or predictors of treatment response, measures of disease progression, measures to identify dose ranges prior to clinical studies, preclinical or clinical efficacy testing, toxicity measures for drug development, defining patients to enroll in the clinical study, identifying CNS abnormalities, etc. c. Assessment tools for pediatric mental health disorders that are sensitive to developmental change, gender and cultural diversity, variation in cognitive and behavioral functioning, hearing and/or speech impairment, and co-morbid disorders. d. Innovative approaches to assessing mental disorders using new statistical and psychometric techniques such as Item Response Theory. e. Computerized methodologies for assessing various mental disorders suitable for use in primary care settings, e.g. they would need to function rapidly and reliably. f. Biological and behavioral measures to define and assess specific impairment-related components of psychiatric disorders, e.g., cognitive dysfunctions in schizophrenia. g. Development of valid and reliable measures that operationalize functioning within and across developmental periods, and that can be used in a variety of service settings. Such measures can lead to more accurate diagnoses, a better understanding of the impact of psychiatric disorders, and better tracking of treatment effectiveness. 3. Behavior Monitoring and Analysis of Pediatric Mental Health Disorders. a. Improve or create new video devices to monitor human behavior and ease analysis of behavior. b. Computer software to ease analysis of behavior monitored by video or telemetry systems. c. Automated methods to detect specific emotional states using behavioral and autonomic indicators: This Division is specifically interested in technologies that can identify children with heightened or dampened emotional states that could be associated with particular mental health disorders, including children with limited verbal skills (i.e., very young or developmentally disabled). If the technology will primarily be used to investigate basic mechanisms of behavior, the Division of Neuroscience and Basic Behavioral Science at NIMH would be the most appropriate division to contact. 4. Intervention Development for Childhood-Onset Mental Disorders. a. Strategies (e.g., animal behavioral testing, computer simulation) for evaluating, in early developmental periods, the effects of pharmacological agents on specific functional domains and brain circuits associated with mental disorders. b. Strategies (e.g., animal behavioral testing, computer simulation) for evaluating, in early developmental periods, the effects of cognitive or behavioral interventions (e.g., cognitive rehabilitation, attention training) or device-based protocols (e.g., transcranial magnetic stimulation or direct current stimulation) on specific functional domains and brain circuits associated with mental disorders. c. Methods for evaluation of long-term effects of psychotherapeutic drug administration or brain stimulation protocols in developmental animal models. 5. Methodological Research and Development. There is a need to devise new ways of data collection, analysis, management and dissemination. Examples include: a. Technologies that use the most recent technological advances to identify aberrations in the CNS during development, associated with mental disorders. Once these aberrations are identified and localized, rational therapies can be developed and evaluated. b. Innovative, computer-based methods to monitor preventive and treatment intervention efforts and correlate them with outcome measures are needed. Results should be accessible to other interested parties without compromising the privacy of the individual. c. Development of innovative software for addressing the integration of distributed cross-disciplinary data sources into coherent knowledge bases. The data should focus on pediatric mental health disorders. d. Computer-based intervention development for parents or for school settings. e. Development of databases containing detailed genetic and behavioral information on pediatric populations and their families, as resources for the field in investigations of gene x environment interactions. f. Mathematical, statistical and computer algorithms that could be used to analyze large and/or complex data sets. Examples of these data sets include those derived from functional imaging studies. Among other applications, these could be used to segment images such as those obtained from magnetic resonance imagers, filter noise, visualize data or search vast data sets for specified patterns or data (e.g., use of pattern recognition algorithms to search time series data sets obtained from electrophysiological recording of neural activity, or video data obtained from behavioral analysis of genetically altered animals). Improved techniques for path analysis when examining functional imaging datasets would also be of interest. B. Child and Adolescent Treatment and Preventive Intervention Research. An estimated one in ten children and adolescents in the United States suffers from mental illness severe enough to cause some level of impairment. Yet, it remains unclear what treatments are the best and safest for these developing age groups. A priority for this program is to support research and development of novel psychopharmacological or psychosocial approaches for the treatment and prevention of mental illness in childhood and adolescence, in subjects aged 18 and below. The goal of this research is broad and inclusive with respect to the heterogeneity of patients, the severity and chronicity of disorders, and the range of outcomes measured. Disorders studied include all mental and behavioral disorders. Interventions studied include pharmacologic approaches (individual and combination medications), somatic approaches, behavioral and psychotherapeutic approaches. Research is supported on individual and combined approaches. Research that translates findings on basic physiological or behavioral processes into novel preventive or treatment interventions is especially encouraged. Effectiveness studies that focus on interventions of known efficacy are assigned to the Division of Services and Intervention Research. Human subjects include child and adolescent age groups covering the full range of mental disorders individually and in complex patterns of comorbidity with other mental disorders and behavioral problems (e.g., anxiety and depression) and substance abuse (e.g., depression and alcohol abuse). 1. Pharmacologic Treatment Intervention. Clinical testing of novel mechanism therapeutics is the principle aim of this technology development section. This includes Phase IIa and proof of concept studies in pediatric subjects. It is expected the pharmacologic agents selected for these studies be IND-ready and based on novel molecular targets identified through basic and clinical research, preclinical research and animal model research relevant to understanding developmental aspects of mental illness. 2. Combined Intervention. Areas include all research that combines different treatment modalities in a single combined or comparative protocol (e.g., pharmacologic plus psychosocial intervention). 3. Psychosocial Intervention. Areas include development and application of new psychotherapeutic, behavioral, and psychosocial treatments, based on the latest advances in development neuroscience. 4. Preventive Intervention Program. Areas include preventive intervention studies in which efficacy has not been demonstrated, including those designed to reduce the risk of onset or delay onset of mental disorders, dysfunctions and related problems within asymptomatic and subclinical populations and those related to treatment (e.g., prevention of relapse, recurrence) or side effects (prevention/ minimization of tardive dyskinesia, etc.). Prevention studies that focus on behavioral problems, without a focus on a specific mental health disorder or a specific domain of function that significantly impacts a mental health disorder (e.g. cognitive function) should contact NICHD. 5. Development and Maintenance of Clinical Trial Networks. Areas include the development of hardware/software to facilitate research collaborations in conducting clinical trials, technologies to facilitate data sharing, merging of multiple data sets, and the development and maintenance of common protocols across research sites working on a common pediatric preventive or treatment intervention. C. Science Education in Mental Disorders. There is a critical need for improvement in science education, particularly in areas specifically related to brain, behavior and mental illness. Examples include: 1. Research on the best ways to present neuroscience and behavioral science information, in the context of mental health disorders, to particular groups of students (e.g., kindergarten through sixth grade). 2. Computer-based systems to teach students how to observe scientific phenomena related to the brain, behavior and mental illness, and to report them clearly in writing. 3. Research on better ways to communicate new knowledge and directions of scientific growth in the area of neuroscience and mental illness to teachers and curriculum developers. For further information on Developmental Translational Research-related topics, contact: Margaret Grabb, Ph.D. National Institute of Mental Health 6001 Executive Blvd. Room 7201 Mail Stop Code 9645 Bethesda, MD 20892 301-443-3563, Fax: 301-443-1731 Email: mgrabb@mail.nih.gov Division of Adult Translational Research and Treatment Development (DATR) The DATR is responsible for planning, directing and supporting programs of research, research training, research dissemination and resource development aimed at understanding the pathophysiology of mental illness and hastening the translation of behavioral science and neuroscience advances into innovations in clinical care. The Division supports a broad portfolio of pre-clinical and human clinical studies that focus on the phenotypic characterization and risk factors for major psychiatric disorders. In addition , the Division studies psychiatric disorders of late life. The division is comprised of four branches. These branches are: The Adult Psychopathology and Psychosocial Intervention Research Branch, The Clinical Neuroscience Research Branch, the Geriatrics Research Branch and the Experimental Therapeutics Branch. This division also includes a program on Traumatic Stress Disorders Research. Their respective functions are as follows: Adult Psychopathology and Psychosocial Intervention Research Branch. This branch promotes the integration of basic behavioral and neuroscience findings into translational research on the foundations of psychopathology and functional disability. The branch targets new science based assessment, prevention, treatment and rehabilitation practices including research on causal risk and protective factors for mental disorders, mechanisms that convert vulnerability into psychiatric symptoms and disability and use of modern psychometric and statistical theories to advance nosology and assessment. Other specific areas of emphasis include mood, eating disorders, anxiety disorders and schizophrenia. Clinical Neuroscience Branch. The focus of this branch is on the understanding of the neural basis of mental disorders. Human and animal studies are supported on the molecular, cellular and systems level of brain function designed to elucidate the pathophysiology of mental disease and to translate these findings to clinical diagnosis, treatment and prevention. These approaches are applied to the spectrum of mental disorders including schizophrenia, depression, bipolar disorder, anxiety disorder and other brain disorders. Areas of emphasis include: identification of valid and unique neurophysiological markers or complexes of markers for the major mental disorders and development of animal and or computational models that accurately mimic complex neurophysiology or behaviors characteristic of mental illness. Geriatrics Research Branch. This branch focuses on research and resource development in the etiology, pathophysiology and course of mental disorders of late life as well as in the treatment and rehabilitation of persons with these disorders. Disorders studied include mood, anxiety and personality disorders, psychotic disorders and schizophrenia, psychiatric syndromes and behavioral disorders in Alzheimer’s Disease and related dementias, suicide, and eating disorders. Selected areas of emphasis include: development of more reliable and valid phenotypes, assessments and biological and behavioral markers for late-life mental disorders; development of improved treatment and preventive intervention techniques for use in geriatric care settings; and identification of genetic, brain imaging and other predictors of variability in older adults’ treatment response. Experimental Therapeutics Branch. This branch supports multidisciplinary research on novel pharmacological approaches to the treatment of mental disorders, evaluation of existing treatments of mental disorders, development and assessment of putative biomarkers of psychiatric disease and treatment response and development and testing of novel treatments. Studies supported include early phase clinical studies of new medications, studies to predict treatment response and studies to validate biomarkers or predictors of therapeutic response to pharmacological intervention. Side effects of therapeutic agents are also given emphasis. Traumatic Stress Disorders Research Program. This program supports integrating basic behavioral and neuroscience findings into translational research on psychopathology associated with trauma exposure. Areas of emphasis include developing disorder and risk assessment tools based on individual differences, the development of treatment and preventive interventions for posttraumatic disorders, and identifying mechanisms of therapies and mechanisms of disorder that are impacted by therapies. This program also supports a broader continuum of research (basic science, clinical practice, and health care system factors) focused on the mental health consequences of mass trauma and violence (e.g. war, terrorism, natural and technological disaster), including interventions and service delivery in children, adolescents, and adults impacted by mass trauma. All applications relevant to the mission of the Division of Adult translational Research and Treatment Development will receive full consideration. Possible areas for future research include: A. Instrumentation for Clinical Research. Up-to-date hardware/software systems that use the most recent technological advances are needed to identify CNS dysfunction(s) related to mental disease. Once these dysfunctions are identified and localized, rational therapies can be developed and evaluated. 1. Physiological and Behavioral Monitoring: Technologies are needed to continuously monitoring physiological data (e.g., temperature, activity, sleep duration, EEG activity, ECG, pulse rate) with behavior, noninvasively and without impacting behavior. These monitoring devices should be designed for use with subjects that have a mental illness. 2. Data Analysis from Complex Data Sets: Computational tools are needed to record, catalog, categorize and identify interrelationships between several of the above measures. 3. Deep Brain Stimulation Technologies: Improvements in deep brain stimulation technology in human subjects/patients is increasingly important as this technique becomes more common as a potential treatment option for Obsessive Compulsive Disorder, depression, and other disorders. B. Technologies for Adult Clinical Research. It is important to develop reliable methods that can correctly identify the normal and abnormal components of cognitive, emotional, and psychosocial behavior in human development. Computer-based methods of accomplishing this aim are needed to increase the accessibility and reliability of information made available to the research community. 1. Assessment Tools. a. Technologies to assess CNS effects of psychosocial variables and interventions. b. Innovative approaches to assessing mental disorders using new statistical and psychometric techniques such as Item Response Theory. c. Computerized methodologies for assessing various mental disorders suitable for use in primary care settings. d. Inexpensive methodologies or techniques for assessing adherence to medication regimens. e. Innovative technologies for identifying and directing clinical attention to potentially adverse psychotropic drug interactions, particularly in vulnerable patients with complex regimens involving multiple medications. f. Simple-to-use tools for assessing individual risk profiles for the development of various mental disorders. 2. Methodological Research and Development. There is a need to devise new ways of data collection, analysis, management and dissemination. a. New relatively culture-free taxonomies and/or measures of basic behavioral and social phenomena that can be employed in research across socio-cultural contexts. b. Innovative computer-based observation techniques, and computer software and hardware that allow on-line methods for characterization of interpersonal interactions in groups. c. Low cost microcomputer software for the recording and analysis of patterns and sequences in observed social interactions. d. Causal modeling methodology as applied to correlational longitudinal data sets. e. A data translation and communication package for collecting, archiving, and making available existing longitudinal behavioral sets to the scientific community for secondary or meta-analyses. f. Flexible user-friendly software for control of timed, multi-modal stimulus presentation and response collection for experiments on perception and cognition. g. Development of improved standardized instruments and methods for assessing assets, deficits, and disorders in adult and late life. C. Adult Treatment and Preventive Intervention Research. 1. Development of novel methods to enhance efficiency of early phase clinical trials. 2. Development of novel assessments of psychopathology suitable for use in clinical research. 3. Identification of causal risk and protective factors for mental disorders. 4. Development of standardized assessments of psychiatric and comorbid disorders. 5. Develop psychometrically sound methods for assessing the cognitive, affective and behavioral response systems believed to underpin clinical symptoms and functional impairments. 6. Identify valid markers of illness onset. 7. Develop new definitions and measures to assess functioning in people with psychiatric disorders including self-reports, tests that simulate real-world tasks and new approaches to ratings by observers. 8. Creation and validation of new measures of functional capacity. 9. New approaches to assess the functional effects of drug or psychosocial interventions to treat mental disorders. 10. Identify valid and unique neuropsychological markers for the major mental and personality disorders. 11. Identify more reliable and valid phenotypes, assessments and behavioral markers for late-life mental disorders. 12. Development of techniques for maintaining or restoring mental capacities in older adults who experience declining learning and memory abilities due to age-related brain disorders. D. Experimental Therapeutics Research. 1. Early phase clinical studies of new medications targeting major mental illnesses or symptom domains now lacking adequate treatments. 2. Development of novel somatic treatments or medical devices for the treatment of mental illness. 3. Development of reliable and stable biomarkers/biosignatures that can identify at-risk individuals prior to disease onset, biological and behavioral indicators or predictors of treatment response, measures of disease progression, measures to identify dose ranges prior to clinical studies, preclinical or clinical efficacy testing, toxicity measures for drug development, defining patients to enroll in the clinical study, identifying CNS abnormalities, etc. Examples of side effect issues include: a) Development of new approaches to understand and predict the types, rates and pathophysiology of adverse effects of psychotropic medications. b) Development of new techniques to predict emergence of later abnormalities in body weight and disorders of glucose and lipid metabolism during treatment with psychotropic drugs. c) New methods to predict and assess the effects of psychotropic medication on cerebrovascular and cardiovascular function. 4. New approaches to understand age-related changes on the emergence of adverse effects from psychotropic medications. 5. New approaches, including pharmacological to prevent or reduce the negative metabolic, vascular and other side effects of psychotropic medications. For further information on these topics, contact: Margaret Grabb, Ph.D. National Institute of Mental Health 6001 Executive Blvd. Room 7201 Mail Stop Code 9645 Bethesda, MD 20892 301-443-3563, Fax: 301-443-1731 Email: mgrabb@mail.nih.gov Division of AIDS Research (DAR) The DAR supports research to develop and disseminate behavioral interventions that prevent HIV/AIDS transmission, support HIV/AIDS treatment and care, and understand and alleviate the neuropsychiatric consequences to HIV/AIDS infection. Specific topics related to these research areas are listed below. Inquiries are encouraged. THE CENTER FOR MENTAL HEALTH RESEARCH ON AIDS: A. Technologies to Facilitate Research in HIV/AIDS Prevention and Care 1. Innovative approaches for assessing HIV sexual risk behavior among research participants and at-risk populations, including biomarkers of risk behavior. 2. Development of electronic, on-line archives of validated HIV/AIDS research instruments. 3. Development and validation of novel self-report, computer-assisted, and virtual reality HIV/AIDS research instruments and assessments. 4. Development of methods to assess functioning in families in which there is an HIV infection in order to develop improved treatment modalities. 5. New tools and methods that physicians and researchers could use to monitor patient adherence to prescribed HIV/AIDS antiretroviral medication regimens in real time. 6. Computational systems that physicians and researchers can use to model the development of drug resistance based on degree and pattern of patient adherence to HIV/AIDS antiretroviral medications. 7. Technologies to assist the merging of multiple forms of HIV/AIDS data sets (e.g., community- or clinic-level data, pharmacy claims, patient self-reports, etc.) and to facilitate innovative and complex analytic strategies. 8. Causal modeling methodology as applied to correlational longitudinal data sets collected in HIV/AIDS research. 9. The development and advancement of innovative research trial designs (e.g., fixed adaptive, encouragement, partially randomized preference) for HIV/AIDS prevention and care research. 10. Technology and electronic systems that will facilitate participant scheduling, tracking, and retention in HIV/AIDS clinical trials and longitudinal studies. 11. The application of modern technology to enhance the science, operation, and management of multi-site HIV/AIDS clinical trials and behavioral research. 12. A data translation and communication package for collecting, archiving, and making available existing HIV/AIDS behavioral data sets to the scientific community for secondary or meta-analyses. B. HIV Prevention Interventions. CMHRA seeks innovative technologies and strategies that will help reduce HIV transmission risk behavior, especially among populations at high risk for HIV infection (such as ethnic minority populations and young men-who-have-sex with men), as well as among individuals who are infected with HIV. 1. Development of methods to reduce, prevent and/or change HIV-associated and STD risk behaviors. 2. Development of school-based HIV prevention curricula, including innovative uses of emerging technologies. 3. Curricula, computer software and virtual reality programs that provide communication skills, training and role-play exercises for HIV risk reduction. 4. Methods to increase use of HIV testing and that facilitate effective test result obtainment, confirmation and counseling. 5. Novel approaches to address the issue of relapse prevention of HIV-associated risk behaviors. 6. Development of new behavioral strategies to reduce high-risk HIV transmission behavior among persons recently infected. C. HIV/AIDS Educational Tools, Curricula, and Scientific Training 1. Development of computer-based or online HIV/AIDS prevention curricula and interventions for parents, foster parents and guardians, schools, or community settings. 2. Research on the best ways to present HIV/AIDS science and prevention information in an age-appropriate manner to particular groups of students. 3. Development of print and/or computer based materials to assist primary care practitioners in informing their patients about HIV risk and prevention. 4. Innovative approaches to the development of curricula for training in multicultural issues and development of cultural competence in HIV risk assessment. 5. Develop and test technologies designed to modify the practice behaviors and decision-making process of health care providers to improve the quality of screening, counseling, prevention, and treatment services for HIV positive persons or individuals at-risk for HIV. 6. Video and computer-assisted methods to train health and mental health care providers in the psychosocial and neuropsychiatric aspects of HIV infection and AIDS. 7. Development of materials and programs to assist health care practitioners in improving patient adherence to HIV/AIDS medical regimens. 8. Development of training materials to increase awareness regarding the neurodevelopmental consequences of HIV infection in children in developing countries. 9. Development of strategies and systems to encourage entry and retention of individuals with non-HIV/AIDS science backgrounds (engineers, computer scientists, medical anthropologists, law, business) or perspectives (individuals from under-represented communities) into the HIV/AIDS research field. 10. Development of systems to keep established researchers and practitioners up-to-date on the findings and implementation of HIV research. D. Systems to Advance the Dissemination and Implementation of HIV/AIDS Interventions 1. Web-based networks and software for the dissemination, identification, and tailoring of efficacious HIV/AIDS behavioral interventions targeting at-risk populations. 2. Development of technological approaches to increase the sustainable uptake of scientifically based HIV/AIDS prevention interventions across diverse community settings. 3. Development of strategies or application of technology to assist organizations in identifying and implementing proven HIV prevention strategies and in addressing health disparities. 4. Novel methods of disseminating HIV prevention materials to be used in community based outreach programs for special populations (school dropouts, homeless, street youth, incarcerated youth). 5. Development of innovative approaches to link researchers with community providers in the implementation of research-based HIV prevention efforts at the community level. 6. Systems that build the capacity of HIV/AIDS community-based organizations to conduct program evaluations and document intervention outcomes for the purposes of maintaining and enhancing ongoing intervention programs. E. Technologies to Support HIV/AIDS Mental Health Services 1. Use of technology to develop and disseminate curricula for training clinicians and other health care practitioners in the prevention and treatment of HIV-related mental disorders. 2. Development of novel programs to help people recognize and access treatment of mental health problems arising from living with HIV/AIDS as a long-term chronic condition. 3. Develop rehabilitative approaches to alleviate HIV-associated neurodevelopmental abnormalities that may restrict children’s academic achievements and quality of life. 4. Development of innovative approaches to reduce stigma often expressed toward individuals with HIV/AIDS. 5. Develop and test interventions for appropriate HIV status disclosure to relationship partners, family members, and health care providers, in an effort to optimizes the likelihood of positive outcomes. F. Tools to Monitor and Improve Patient Adherence to HIV/AIDS Treatment 1. Development of novel methods to expedite and enhance linkage to primary medical care for individuals who receive HIV-seropositive test results in community-based settings. 2. Technologies that will electronically monitor HIV/AIDS patient adherence to antiretroviral medications and that will use wireless technology to radio this data back to providers and/or researchers for real-time monitoring of adherence. 3. Clinic-based systems that will screen HIV/AIDS patients for medication adherence while they await medical appointments and that will immediately integrate these patient reports into the electronic medical record so this information is routinely available to physicians during their appointments with patients. 4. Development of novel tools or methodologies designed to improve patient adherence to HIV/AIDS drug therapies. 5. Systems that improve adherence to HIV/AIDS medical care by enhancing the ability of patients to monitor and manage scheduled medical appointments, routine prescription refills, and daily medication doses. 6. Novel systems for distributing, dispensing, or administering antiretroviral drugs that are designed to enhance patient adherence to these regimens. 7. Biologically-based technologies that will aid medical doctors in determining how a particular individual may respond to a particular HIV/AIDS medication, i.e. “individualized medicine.” For example, genomic and phenotypic information combined could be used in determining whether a drug will be an effective treatment for an individual. Likewise, genomic and phenotypic information may help to identify which patients are at risk for drug-induced side effects. G. Research Tools and Treatments for Neuro-AIDS: HIV-1 Infection and the Nervous System 1. Development of novel non-invasive (e.g., neuroimaging) approaches to assess and study mechanisms of neurologic and neurocognitive dysfunction associated with HIV infection. 2. Development of in-vivo and in-vitro models to assess mechanisms of HIV-1 trafficking into and out of the CNS, mechanisms of neuropathogenesis and therapeutic strategies for eradicating HIV-1 in the CNS. 3. Development of novel molecular markers for NeuroAIDS using proteomics, microarrays and neuroimaging. 4. Development of novel molecular approaches to study compartmentalized viral evolution in the CNS. 5. Development of improved anti-retroviral therapeutic strategies for targeting CNS infections including: nanotechnologies, facilitated entry of anti-retroviral therapeutic agents through the blood-brain barrier by manipulation of transporter systems and development of novel anti-retroviral therapeutic agents that readily pass through the blood-brain barrier. 6. Development of novel therapeutic approaches to block or reverse CNS dysfunction associated with HIV infection. 7. Discovery and development of novel tools and cost effective methods for detecting the efficacy and neurological and neuropsychiatric side effects of anti-retroviral medications. 8. New approaches to reduce transmission risk or neuro-cognitive impairment in persons with recent HIV infection (0-6 months post exposure). 9. Novel therapeutic and diagnostic instrumentation development for the detection and treatment of neurological manifestations of HIV co-infections such as tuberculosis, hepatitis C, toxoplasmosis, that can be used in developing countries. 10. Development of novel or refinement of existing cell-based assays designed to screen compounds (small molecule, large molecule, bioproduct, etc.) targeted to treat neurologic and psychiatric disorders that are associated with HIV/AIDS. 11. Development of novel or refinement of existing animal models to test the efficacy and toxicity of new agents targeted specifically towards eliminating/eradicating HIV or its sequelae in the brain. 12. Discovery and development of small molecular inhibitors or enhancers targeted to mechanisms that play critical roles in viral replication pathways especially in the CNS. 13. Improvement/validation/characterization of the existing in vitro and animal models that are used for screening compounds that have therapeutic potential for NeuroAIDS and its associated complications. 14. Novel compounds or adjunctive therapies that have the potential to protect/ameliorate/treat the long-term neurologic and psychiatric side effects of ARVs in the presence or absence of psychotropic medications. 15. Novel models or methods for the pharmacokinetic/pharmacodynamic studies to detect long-term neuropsychological adverse effects of ARVs. 16. Applications that assess the neuroprotective potential or inhibition of HIV replication in the brain with FDA-approved drugs that are currently registered for other indications (off-label validation studies). 17. Development/improvement of cost effective methods, assays, or instruments that detect currently approved ARVs plasma concentrations in relationship with disease progression. 18. Discovery and development of biomarkers designed to detect drug efficacy, measure viral load, or provide evidence that agents are directed against the targets in the CNS or peripheral nervous system (PNS). 19. Development of technology (IT or other) to optimally study/analyze/report on adverse effects of ARVs in the presence of other medications, especially psychotropic medications, drugs of abuse, or medications to treat drug abuse. 20. Develop or adapt neurological/ neuropsychological/neurobehavioral assessments to evaluate HIV associated abnormalities in adults/children in resource poor environments that are adaptable to different cultures and languages. For information related to programs supported by the Center for Mental Health Research on AIDS please contact: Michael J. Stirratt, Ph.D. Program Officer, Adherence Program and SBIR/STTR Programs Center for Mental Health Research on AIDS Division of AIDS and Health Research National Institute of Mental Health 6001 Executive Blvd., Room 6199 Bethesda, MD 20892 (Postal mail) Rockville, MD 20852 (FedEx, UPS) Telephone: 301-443-6802 Fax: 301-443-9719 E-mail: stirrattm@mail.nih.gov Division of Services and Intervention Research The Division of Services and Interventions Research supports research, research demonstrations, research training, resource development, and research dissemination in prevention and treatment interventions, services research, clinical epidemiology, and diagnostic and disability assessment. The division is composed of three branches: Services Research and Clinical Epidemiology Branch, Adult Treatment and Preventive Intervention Research Branch, and Child and Adolescent Treatment and Preventive Intervention Research Branch. The Division supports two critical areas of research: • Intervention research to evaluate the effectiveness of pharmacologic, psychosocial (psychotherapeutic and behavioral), somatic, rehabilitative and combination interventions on mental and behavior disorders-including acute and longer-term therapeutic effects on functioning across domains (such as school, family, peer functioning) for children, adolescents and adults. • Mental health services research The interventions focus is broad and inclusive with respect to the heterogeneity of patients, the severity and chronicity of disorders, and the variety of community and institutional settings in which treatment is provided. It includes clinical trials evaluating the effectiveness of known efficacious interventions, as well as studies evaluating modified or adapted forms of interventions for use with additional populations (such as women, ethnic and racial groups), new settings (public sector, pediatric primary care, schools, other non-academic settings, communities at large) and people with co-occurring disorders. Other foci include: identifying subgroups who may be more likely to benefit from treatment, evaluating the combined or sequential use of interventions (such as to extend effect among refractory subgroups), determining the optimal length of intervention, establishing the utility of continuation or maintenance treatment (that is, for prevention of relapse or recurrence), and evaluating the long-term impact of efficacious interventions on symptoms and functioning. Services research covers all mental health services research issues, across the lifespan and disorders, including, but not limited to: • Services organization, delivery (process and receipt of care), and related health economics at the individual, clinical, program, community and systems levels in specialty mental health, general health, and other delivery settings (such as the workplace). • Interventions to improve the quality and outcomes of care (including diagnostic, treatment, preventive, and rehabilitation services. • Enhanced capacity for conducting services research • The clinical epidemiology of mental disorders across all clinical and service settings. The Division also provides biostatistical analysis and clinical trials operations expertise for research studies; analyzes and evaluates national mental health needs and community research partnership opportunities; and supports research on health disparities. The priorities for 2011 should focus on technologies that advance the scientific opportunities and recommendations of “The Road Ahead: Research Partnerships to Transform Services, A Report by the National Advisory Mental Health Council’s Workgroups on Services and Clinical Epidemiology Research.” “The Road Ahead: Research Partnerships to Transform Services, A Report by the National Advisory Mental Health Council’s Workgroups on Services and Clinical Epidemiology Research,” and the NIMH Strategic Plan. Examples are listed below: 1. Clinical Trials Methodologies: The development, testing and refinement of methodologies, instruments and statistical approaches to facilitate collaborative clinical trials for the prevention, treatment and rehabilitation of individuals with mental disorders; the development of innovative trials design (e.g., fixed adaptive, encouragement, partially randomized preference) the application of modern technology to enhance the science, operation, and management of multi-site mental health clinical trials; and the development of mental health clinical trial archives. The development of portable clinical trial management systems such as serious adverse event (SAE) oversight and monitoring software. Adaptation of existing clinical trial methodologies to study mental health disorders. Development of common data elements to enhance uniformity across clinical trials with and amongst disorders. 2. Science Training and Education: SBIR applications must focus on DSIR’s research priorities. Develop, modify and test new and existing technologies, strategies and approaches to: (1) enhance science and research training across the educational/ career pipeline; (2) improve scientific literacy for clinicians and service/ organizational providers; (3) encourage entry and retention of individuals with non-mental health science backgrounds (engineers, computer scientists, medical anthropologists, law, business) or perspectives (individuals from under-represented communities) into the mental health services and interventions field; (4) keep established researchers and practitioners up-to-date on the findings, implementation, and methods of services and interventions research; and (5) facilitate participatory research with individuals, families and communities. This can include the development of science/ research education materials, curriculum, methodologies and web-based programs relevant to the mission of the division; the development of networking and collaborative approaches to research training in mental health interventions and services research; and the development of multi-media approaches (combined with traditional strategies) to improve the level of scientific and career mentoring that mental health services and interventions researchers receive. 3. Public Health Oriented Pharmacoeconomics: Develop and test simulation models for estimating the amount of total out-of-pocket expenditures (co-payments) for the most frequently prescribed psychotropic drugs under different insurance benefit scenarios and/or under different pharmacy benefit management scenarios. Models should also be developed to accommodate common combined pharmaceutical approaches. 4. Dissemination: Development of technological approaches to increase the sustainable uptake of scientifically based treatments and services across diverse community settings. This could include web-based interactive tools for state/county mental health or related (e.g., schools) agencies around implementation of evidence-based practices. Development of innovative ways (e.g., new technology, use of multi-media) of disseminating information to stakeholders. Development of new approaches to the dissemination and implementation of evidence based mental health interventions to underserved populations (e.g., rural/frontier, aging individuals with neuropsychiatric disorders). Development of technology to enhance conduct of clinical trials and the dissemination of their results. 5. Implementation: Application of new technologies, approaches and strategies to identify and utilize active therapeutic ingredients in complex community-based services and programs that optimize functioning and sustain community reintegration of people with mental disorders. Use of technologies and strategies to assist service systems to more adequately plan for transitions (e.g., child to adult system, prison to community) and seamlessly integrate mentally ill individuals moving between these sectors. 6. Merging Multiple Data Sets: Merging multiple data sets (e.g., claims, trials, pharmacy etc.) for innovative and complex analytic strategies. 7. Community Outreach to Diverse and Underserved Populations: Application of new technologies and strategies to develop, test, and refine culturally appropriate materials and approaches to: foster help-seeking and engagement of diverse and underserved populations in research-based mental health treatment and prevention; to foster participation in community based research by diverse and underserved populations; and to inform diverse provider groups about state-of-the-art mental health treatments and services in order to facilitate their implementation of these interventions. 8. Computerized Methodologies for Mental Health Services Research: Applications need to focus on computerized methods to assess mental disorders in primary care settings including screening devices for identifying mental disorders across the life-span; development of computer software and hardware that allow conducting computer assisted interviews with severely mentally ill people for research purposes to obtain information on their quality of care; design work to move assessment as rapidly as possible to computerized adaptive testing (CAT); apply audio and video technologies to assess patient’s treatment preferences. A. Services Research and Clinical Epidemiology Branch. The branch supports research on the organization, financing, delivery, effectiveness, and appropriateness of mental health care in everyday settings in order to find ways to improve the effectiveness, efficiency, and equity of mental health services (including preventive services) in community and other settings. Also supported are studies on pharmacoeconomics, pharmaco-epidemiology, and the distribution, determinants, and course of mental illness in the context of various clinical settings. Mental health services include mental health care provided in specialty mental health and general health care settings, including primary care, hospitals, nursing homes, and other residential care settings, as well as in educational settings and various legal system settings, such as jails, juvenile detention and correctional facilities, prisons, and probation and parole programs. Other services often needed by mentally ill persons include social services, vocational and rehabilitation services, welfare, and housing. Relevant services include those provided to children and adolescents with emotional disorders, adults and elderly adults with mental disorders, and persons with mental illness that co-occurs with physical illness and with alcohol and/or drug abuse disorder. Research methodologies include ethnographic studies, surveys, and analyses of secondary data, randomized controlled trials, quasi-experimental designs, cohort, and case-control studies. Advances in clinical epidemiology, mental health treatment and services research fields have made it imperative that intensive work continue in the areas of assessment/screening technologies, outcome assessment measurement and measurement packages, dissemination technologies, data analysis techniques, and the training of clinicians and providers. The translation of efficacious and effective treatments into primary care, community mental health centers, and managed care settings is both a major challenge and opportunity to develop technologies and systems that will improve the care and rehabilitation of patients and enable them to profit from the research advances that have been made. Research is needed on the dissemination of empirically supported treatments or services. 1. Methodological Research Program. Supports studies that involve development, testing, and refinement of methodologies and instruments to facilitate research on services for mentally ill persons, including measures of severity of illness, family burden, social support, quality of care, effectiveness of care, direct and indirect cost of mental disorders, and short-term and long-term outcome measures; studies submitted by statisticians, psychometricians, and other experts in research methodology and scientific data analysis for work on the design, measurement, and statistical challenges inherent in conducting mental health services research. 2. Outcomes and Quality of Care Research. This program is concerned with strengthening the theoretical and empirical base for mental health services research by including approaches that derive from sociology, anthropology, and the behavioral sciences in general. The program supports research relating to issues of culture, social systems, and social networks as they relate to help seeking, use, and provision of services, effectiveness, quality, and outcomes of services. 3. Systems Research Program. Supports studies on organization, coordination, and collaboration of mental health and related services both within and across care settings in order to improve mental health outcomes and prevent or treat co-occurring substance abuse, physical problems, and other behavioral health disorders. Service sectors of interest include: the criminal justice system, housing and other social services, community support, post-trauma services, and adult autism services. Also relevant are studies to establish the effectiveness of legal mechanisms relevant to persons with mental illness, such as outpatient commitment, community monitoring, and guardianship; and the development of the role and expertise of social workers in mental health research activities. 4. Disparities in Mental Health Services Program. Plans, stimulates, disseminates, and supports research on the complex factors that influence disparities in mental health services, particularly across special population groups such as racial and ethnic groups, as well as women and children, and persons living in rural and frontier areas. The program addresses care delivered in a variety of settings such as the specialty mental health sector, the general medical sector, and community settings (such as schools). Also, it supports research that examines innovative services interventions (such as community-based participatory methods, faith-based) to overcome mental health disparities related to mental health service delivery and use. 5. Sociocultural Research Program. Is concerned with strengthening the theoretical and empirical base for mental health services research by including approaches that derive from sociology, anthropology, and the behavioral sciences in general. The program supports research relating to issues of culture, social systems, and social networks as they relate to help seeking, use, and provision of services, effectiveness, quality, and outcomes of services. 6. Child and Adolescent Services Research Program. Includes research on the quality, organization, and content of services for children with mental disorders and their families. The program focuses on child mental health services provided in multiple sectors and settings, such as schools, primary care, child welfare, juvenile justice, and mental health. Program emphases include practice research within child service systems, research testing the outcomes of innovative child service delivery models, and studies that examine the adaptability or sustainability of child mental health services. 7. Financing and Managed Care Research. Supports research on economic factors affecting the delivery of mental health services including the economic burden of mental illness; financing and reimbursement of public and private mental health services; impact of various forms of managed care and physician payment methods on the cost of mental health care; pharmaco-economics; evaluation of the impact of insurance coverage including mandated coverage and mental health insurance parity on access, cost, and quality; cost-benefit, cost-effectiveness and cost-utility analysis of mental health service interventions; and economic analysis of practice patterns of different mental health providers. The goal of the program is to expand understanding of the role of economic factors in the delivery and use of mental health services and assist in the development of improved mental health financing methods promoting high quality, cost-effective care for people suffering from mental disorders. 8. Primary Care Research. Includes studies on the delivery and effectiveness of mental health services within the general health care sector; recognition, diagnosis, management, and treatment of mental and emotional problems by primary care providers; coordination of general medical care with and referrals to mental health specialists; provision of psychiatric emergency services, consultation/liaison psychiatry, and other psychiatry, psychology, and social work services within the general medical care sector; studies that improve understanding of how best to improve care for people with mental disorders and co-occurring physical conditions. 9. Clinical Epidemiology Research. Includes epidemiologic studies of mental disorders in clinical settings, that is, the distribution of treatments and services in a population; studies to determine usual or best practices and the relationship to patient, provider, and system factors, as well as to outcomes; pharmaco-epidemiology studies; research to identify factors for the development of mental disorders in clinical settings, factors important in the natural history of mental disorders, including comorbid conditions, and the rates of occurrence of mental disorders in clinical and services populations. 10. Disablement and Functioning Research Program. Supports studies on the development of methodologies for assessing disablements and functional status, and the development of global and specific measures of disablements and functional status; the identification and assessment of disablements/functional status in clinical investigations and in clinical epidemiological surveys. In addition, it supports studies of the relationship of rehabilitative and traditional mental health services and service systems; impact of disability benefits and insurance; factors affecting impairments and disabilities during and as an outcome of rehabilitation and other treatments; rehabilitative services focused on specific domains of disabilities, such as work and social relationships; and, factors that influence and sustain community reintegration. 11. Dissemination and Implementation Research Program. Includes studies that will contribute to the development of a sound knowledge base on the effective transmission of mental health information to multiple stakeholders and of the process by which efficacious interventions can be adopted within clinical settings. Research on dissemination will address how information about mental health care interventions is created, packaged, transmitted, and interpreted among a variety of important stakeholder groups. Research on implementation will address the level to which mental health interventions can fit within real-world service systems. Related topics include multilevel decision-making perspectives about services and interventions in community settings, with special focus on translating behavioral science into applied research in these areas. B. Adult Treatment and Preventive Interventions Research Branch. This Branch supports research evaluating the therapeutic (acute, maintenance, and preventive) and adverse effects of psychosocial, psychopharmacologic, and somatic interventions of proven efficacy in the treatment of mental disorders in adults. It includes trials evaluating and comparing the effectiveness of known efficacious interventions, as well as studies evaluating modified or adapted forms of interventions for use with specialized populations (such as women, or specific ethnic or racial groups), new settings (public sector, or computer based), new methods of treatment delivery (e.g., web or computer –based), and people with comorbid physical or mental disorders. 1. Somatic Treatments Program. Areas include electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (RTMS), bright light, physical exercise, and similar nonpharmacologic approaches for which efficacy has been demonstrated. 2. Adult Psychotherapy Intervention Program. Areas of program responsibility include evaluation of the effectiveness of psychotherapeutic, behavioral, and pspychosocial treatments, assessment of standardized approaches to treatment (based on treatment manuals), and applications of psychotherapy treatments. 3. Adult Psychopharmacology Intervention Program. Areas of program responsibility include research involving psychotropic medications of demonstrated efficacy. Examples include evaluation of long-term effectiveness of pharmacotherapy and treatment of subpopulations of recognized diagnostic groups. 4. Adult Integrated Treatment Program. Areas of program responsibility include the use of combined or sequential treatment approaches to improve long-term outcome. A major focus is improvement of efficacious psychopharmacological interventions to maximize symptomatic relief while minimizing adverse reactions. For example, medications may be combined with the full range of therapies in individual, conjoint, or group settings. 5. Preventive Interventions Program. Areas of program responsibility include studies evaluating the effectiveness of preventive interventions, including those designed to reduce the occurrence of mental disorders, dysfunctions and related problems within asymptomatic and subclinical populations and those related to treatment (such as prevention of relapse, recurrence, inappropriate resource use) or side effects. A specially designated programmatic focus is the area of suicide prevention. 6. Rehabilitative Interventions. Areas of program responsibility include evaluation of the effectiveness of psychotherapeutic, behavioral, and psychosocial treatments, assessment of standardized approaches to treatment (based on treatment manuals), and applications of psychotherapy. C. Child and Adolescent Treatment and Preventive Intervention Research Branch. The branch supports research to evaluate the effectiveness of mental health preventive, treatment and rehabilitative interventions- alone or in combination-for children and adolescents (including those co-occurring with other conditions). The Branch also supports research addressing the long-term effectiveness of known efficacious interventions, including their role in the prevention of relapse and recurrence of mental disorders. Areas of emphasis include: Research on the effectiveness of treatment interventions for childhood and adolescent mental and behavioral disorders in practice and community settings to determine the real life therapeutic benefit short-and-long term; Research to prevent mental and behavioral disorders in children and adolescents; Research to build new methodologies that can be effectively used to evaluate the safety of interventions in community settings; Research to determine whether treatment of mental and behavioral disorders in children results in improved outcomes as adolescents and young adults and prevents the negative functional outcomes associated with those disorders (such as substance abuse, academic failure, higher medical costs, co-occurring mental disorders). juvenile justice facilities. 1. Pharmacologic Treatment Intervention Program. Areas of program responsibility include evaluation and comparison of efficacious pharmacological and other somatic treatments for children and adolescents with mental disorders. 2. Combined Intervention Program. Child and Adolescent Combined Intervention Program. Areas of program responsibility include all research that combines different treatment modalities in which efficacy has been demonstrated in a single combined or comparative protocol. 3. Psychosocial Intervention Program. Supports research evaluating the effectiveness of psychosocial interventions on children’s and adolescents mental and behavior disorders, including acute and longer-term therapeutic effects on functioning across domains. It includes trials evaluating the effectiveness of known efficacious interventions, as well as studies evaluating modified or adapted forms of interventions for use with additional populations, new settings, and people with comorbid disorders. 4. Preventive Intervention Program. Areas of program responsibility include research examining the effectiveness of preventive intervention studies, including those designed to reduce the occurrence of mental disorders, dysfunctions and related problems with asymptomatic subclinical populations. D. Clinical Trials Operations and Biostatistics Unit. This Unit serves as the operations focal point for collaborative clinical trials on mental disorders in adults and children. The Unit has responsibility for operations and oversight of both contract-supported and cooperative agreement-supported multisite clinical trial protocols, as well as operations focus on special clinical trial research projects that may be undertaken by the Institute. In addition, the Unit has general leadership responsibility for over-arching matters related to clinical trials operations, such as the coordination of the ancillary protocols across the large trials, development of long-term strategies for clinical trials research (such as clinical trials research networks), improvement of the quality of clinical trials by development and monitoring of operations guidelines, and implementing the NIMH policy for dissemination of public access datasets. Unit staff serves as primary liaison with the Data and Safety Monitoring Boards for all matters related to the operation and conduct of the clinical trials. The Unit provides consultation to Institute staff and grantee/contractor staff on biostatistical matters related to appropriateness of study design, determination of power and sample size, and approaches to statistical analysis of data from clinical trials supported by NIMH. For further information on Services and Intervention Research contact: Adam Haim Division of Services and Intervention Research 6001 Executive Boulevard Room 7160, MSC 9649 Bethesda, MD 20892-9635 301-445-3593 Email: haima@mail.nih.gov
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