Randomized Controlled Trial of the P.L.A.Y. (Play and Language for Autistic Youngsters) Project Intervention for Autism

NCT01768806 | Completed

• 2 other identifiers: 31255112R44MH078431-02A1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

Autism; Autism Spectrum Disorder; PLAY and Language for Autistic Youngsters; Intensive Early Intervention; Parent Training

Outcome Measures

Primary Outcomes (1)

• Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS)

  Autism Diagnostic Observation Scale (ADOS) (Lord ) yields scores in 3 scales: Communication, Social Interaction, and Circumscribed Interests. The ADOS has been repeatedly evaluated as diagnostic measures, it has also been used as an outcome measure of autism severity (Aldred et al., 2004; Gutstein, 2007; Owly et al, 2001, Green et al, 2010). The ADOS distinguishes three levels of severity: Autism, Autistic Spectrum Disorder, and non-autistic. Pre- and post-assessment using the ADOS will be used to determine whether the child's autism severity decreases over time.

  1 year

Secondary Outcomes (2)

• Language as measured by the MacArthur-Bates Communicative Developmental Inventories

  1 year

• Vineland Adaptive Behavior Scale

  1 year

Other Outcomes (1)

• Parent child interaction as measured by the Maternal Behavior Rating Scales and the Child Behavior Rating Scales

  1 year

Study Arms (2)

P.L.A.Y. Project Intervention for Autism

EXPERIMENTAL

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.

Behavioral: PLAY Project Intervention for Autism

Special Education Pre-school

ACTIVE COMPARATOR

Special education pre-school services include 10-12 hours per week of special education preschool, occupational therapy, and speech and language therapy. No intensive intervention is provided.

Behavioral: Special education pre-school

Interventions

PLAY Project Intervention for Autism BEHAVIORAL

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.

Also known as: PLAY, P.L.A.Y. Project

P.L.A.Y. Project Intervention for Autism

Special education pre-school BEHAVIORAL

Special education preschool services included 10-12 hours per week of educational services including speech and language and occupational therapy

Also known as: Special education preschool

Special Education Pre-school

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• We excluded children if they had been diagnosed with Asperger's Syndrome, had identifiable genetic disorders, severe medical conditions, a parent with severe psychiatric disorder or cognitive impairment, and/or families who did not speak English with their child. Families in the CS group who reported receiving intensive intervention (\>10 hours/week of a programmatic approach to ASD-check this) were excluded from the study.

Sponsors & Collaborators

• Richard Solomon MD, Plc: lead
• Michigan State University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ann Arbor Center for Developmental and Behavioral Pediatrics

Ann Arbor, Michigan, 48103, United States

Location

Related Publications (1)

• Solomon R, Van Egeren LA, Mahoney G, Quon Huber MS, Zimmerman P. PLAY Project Home Consultation intervention program for young children with autism spectrum disorders: a randomized controlled trial. J Dev Behav Pediatr. 2014 Oct;35(8):475-85. doi: 10.1097/DBP.0000000000000096.

  PMID: 25264862 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Richard Solomon, MD

  Richard Solomon MD, Plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2013
• First Posted: January 15, 2013
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)