Randomized Controlled Trial of the P.L.A.Y. Project Intervention for Autism

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44MH078431-02A1
Agency Tracking Number: MH078431
Amount: $1,809,090.00
Phase: Phase II
Program: SBIR
Awards Year: 2009
Solicitation Year: 2009
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Small Business Information
3135 S. STATE ST STE 209, ANN ARBOR, MI, -
DUNS: 607704322
HUBZone Owned: Y
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (734) 997-9088
Business Contact
Phone: (734) 997-9088
Email: drrick@aacenter.org
Research Institution
DESCRIPTION (provided by applicant): The development of an [evidence-based], cost-effective and [easily disseminated] form of intensive intervention for children with autistic spectrum disorders (ASD) is a major priority for both the health and education systems in this country. The most recent prevalence estimate for ASD from the CDC is 1 in 150 children. According to the National Research Council, these children need intensive intervention (25 hours/week, 1:1 or 1:2 teacher to pupil ratio), which most states do not provide because a) there is a national shortage of trained personnel, b) such interventions when provided by professionals are very expensive ( 25-60K) and c) an evidence-based, readily disseminated, cost-effective model has not yet been developed and tested for national distribution. The unmet national need is enormous. The P.L.A.Y. Project (Play and Language for Autistic Youngsters) Home Consultation model (PLAY) is an innovative train-the-trainer solution to potentially address this national need. Using Greenspan's DIR/developmental framework, and a highly-structured educational approach including video feedback, home consultants train parents how to be their child's best PLAY partner for one-tenth the cost ( 4K) of having professionals providing intensive services. Preliminary clinical evidence from a pilot study indicates that the model is promising. Parents learned the methods PLAY and children in the intervention group showed clinical as well as statistical improvements. Furthermore, in the Phase I SBIR controlled study just completed, 2 intervention and 2 control sites each enrolled 20 children with ASD. In close partnership with Easter Seals and Michigan State University, the grant successfully piloted the procedures needed for execution of the Phase II trial. The controlled study established the feasibility of doing a larger Phase II trial and control study results, despite small numbers and brief intervention, were encouraging. Early dissemination of the model into the real world settings of community agencies, schools, and hospitals has also been successfully accomplished. The hypothesis for the Phase II trial is that PLAY's parent-training intervention model can significantly improve developmental outcomes for young children with autism. A successful trial would encourage private insurers and government agencies to approve major increases in funding for autism intensive intervention services, resulting in wide dissemination of this model, substantial growth in PLAY's business, and significant social benefit. PUBLIC HEALTH RELEVANCE: The P.L.A.Y. Project trains parents to provide intensive intervention for their young children with autism. We are proposing to carry out a randomized controlled clinical trial to demonstrate effectiveness of this intervention model in community settings. A successful study could impact the national strategies for caring for children with autism.

* Information listed above is at the time of submission. *

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