Randomized Controlled Trial of the P.L.A.Y. (Play and Language for Autistic Youngsters) Project Intervention for Autism
Condition: Autism; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The
      P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project
      Home Consultation model coaches parents, through monthly home visits and the use of video
      feedback, to effectively interact with their young child with autism. The aims of the study
      are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that
      caregivers can be taught to interact in an engaging way with their child (with causing more
      stress), 3.) that the child then interacts better, improves his/her language, and has reduced
      severity of his or her autism.
    

Detailed description: 
      A growing number of children (1 in 88) with autistic spectrum disorders ASD 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
      are very expensive and c) an evidence-based, cost-effective model has not yet been developed
      for national dissemination. The unmet national need is enormous.

      The P.L.A.Y. (Play and Language for Autistic Youngsters) Project Home Consultation model
      (PLAY), under the direction of developmental and behavioral pediatrician Richard Solomon MD,
      is an innovative train-the-trainer solution that could potentially address this national
      need.

      Since publication of the pilot study in 2007*, PLAY was awarded a $1.8 million 3 year NIH
      SBIR (Small Business Innovations Research) grant in 2009 to implement a randomized,
      multi-site, blinded, controlled effectiveness study. This study compares control children
      receiving Community Standard Services (CSS)-12-14 hours of special education pre-school-to
      intervention children receiving CSS plus the PLAY Project-a once a month (3 hour),
      home-based, parent training program using trained masters level home consultants (HCs). PLAY
      operationalizes Greenspan's DIR theoretical framework into a practical approach to help
      parents be more sensitive, responsive, and effective in interacting with their children with
      ASD.

      With Easter Seals National as our clinical partner and and Michigan State University (Hiram
      Fitzgerald PhD) as our evaluation partner, the PLAY Project NIH Grant successfully recruited
      112, 3-5 year old children with autism spectrum disorders, at 5 Easter Seals sites. Each year
      a cohort of 30 families received monthly 3-hour PLAY Project home visits for 12 months. Thus
      a total of 60 intervention families and 60 control families were recruited.

      Final results from both cohorts (n = 112) confirm that PLAY intervention children improved
      when compared to the control group with clinically and statistically significant less severe
      autism as measured by the ADOS, better language scores as measured by the MacArthur Child
      Development Inventories and improved ability to interact as scored by blinded raters using
      Mahoney's Child Behavior (Video) Rating Scale. PLAY parents, after a year of intervention,
      were markedly more sensitive, responsive, and effective during interactions with their
      children as scored by blinded raters using Mahoney's Child Behavior (Video) Rating Scale.
      When compared to control parents, PLAY Parents showed significantly less depression over the
      year of intervention. Despite asking parents to provide 2 hours per day of intervention at
      home parent stress was not increased. Home consultants show fidelity to the model.

      The PLAY Project shows promise as a replicable developmental model of autism intervention
      using an efficient train-the-trainer model at relatively low cost to parents and society that
      can be broadly and quickly disseminated to serve a growing, unmet national need.

      * Solomon R, Necheles J, Ferch C, Bruckman D, (2007) Pilot study of a parent training program
      for young children with autism: The PLAY Project Home Consultation program. Autism Vol 11(3)
      205-224.
    

Intervention name(s): PLAY Project Intervention for Autism; Special education pre-school
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children diagnosed with autism were recruited to the PLAY Project Intervention grant and assigned to a community standard arm (CS) or a CS plus PLAY Project arm of the study. Those in the PLAY Project arm of the study received a one time per month home visit to train caregivers in the PLAY Project methods including video feedback and caregivers also receive mid month feedback based on the video review of interaction.; Special education preschool services included 10-12 hours per week of educational services including speech and language and occupational therapy
Other intervention name(s): PLAY; P.L.A.Y. Project; Special education preschool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorder; PLAY and Language for Autistic Youngsters; Intensive Early Intervention; Parent Training