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

NCT ID: NCT01768806

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

PLAY Project Intervention for Autism

Intervention Type: 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.

Special Education Pre-school

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.

Group Type: ACTIVE_COMPARATOR

Special education pre-school

Intervention Type: BEHAVIORAL

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

Interventions

PLAY Project Intervention for Autism

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.

Intervention Type: BEHAVIORAL

Special education pre-school

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PLAY; P.L.A.Y. Project; Special education preschool

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

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.

-

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan State University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Richard Solomon MD, Plc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Richard Solomon MD, Plc

Locations

Ann Arbor Center for Developmental and Behavioral Pediatrics

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25264862 (View on PubMed)

Other Identifiers

2R44MH078431-02A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3125511

Identifier Type: -

Identifier Source: org_study_id