Ann Arbor, Michigan 48103

  • Autism Spectrum Disorder

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: Children ages 3-5 years 11 months old diagnosed with autism. - 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. -


Study is Available At:


Original ID:

3125511


NCT ID:

NCT01768806


Secondary ID:

2R44MH078431-02A1


Study Acronym:

PLAY


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

3 Years


Maximum Age:

5 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Richard Solomon MD, Plc


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard Solomon, MD
Principal Investigator
Richard Solomon MD, Plc

Study Dates

Start Date:September 2009
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 16, 2013
First Received Date:January 12, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Vineland Adaptive Behavior Scale
Time Frame:1 year
Safety Issues:False
Description:Vineland II Parent/Caregiver Rating Form is a revised version of the Vineland Adaptive Behavior Scales. This parent interview measures age-based standard scores in Communication,Daily Living Skills, Socialization, and Motor Skills, as well as a composite
Outcome Type:Secondary Outcome
Measure:Language as measured by the MacArthur-Bates Communicative Developmental Inventories
Time Frame:1 year
Safety Issues:False
Description:The MacArthur-Bates Communicative Developmental Inventories (MCDI) (Fenson et al, 1993) is a standardized, parent report language measure for children from ages 8-16 months (Word and Gestures Form) and 16-30 months (Words and Sentences Form). (Aim 2, Outc
Outcome Type:Primary Outcome
Measure:Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS)
Time Frame:1 year
Safety Issues:False
Description: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 aut

Study Interventions

Intervention Type:Behavioral
Name:Special education pre-school
Description:Special education preschool services included 10-12 hours per week of educational services including speech and language and occupational therapy
Arm Name:Special Education Pre-school
Other Name:Special education preschool
Intervention Type:Behavioral
Name:PLAY Project Intervention for Autism
Description: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.
Arm Name:P.L.A.Y. Project Intervention for Autism
Other Name:PLAY

Study Arms

Study Arm Type:Active Comparator
Arm Name:Special Education Pre-school
Description: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.
Study Arm Type:Experimental
Arm Name:P.L.A.Y. Project Intervention for Autism
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Richard Solomon MD, Plc
Agency Class:Other
Agency Type:Collaborator
Agency Name:Michigan State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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