Trial record 2 of 509 for:    autism

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

This study has been completed.
Sponsor:
Collaborators:
Michigan State University
Information provided by (Responsible Party):
Richard Solomon MD, Plc
ClinicalTrials.gov Identifier:
NCT01768806
First received: January 12, 2013
Last updated: January 16, 2013
Last verified: January 2013
  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.


Condition Intervention
Autism
Autism Spectrum Disorder
Behavioral: PLAY Project Intervention for Autism
Behavioral: Special education pre-school

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the P.L.A.Y. Project Intervention for Autism

Resource links provided by NLM:


Further study details as provided by Richard Solomon MD, Plc:

Primary Outcome Measures:
  • Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Language as measured by the MacArthur-Bates Communicative Developmental Inventories [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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, Outcome 2) Either form may be used with older, developmentally delayed children. The MCDI has been used in several research studies to assess language in child with autism.

  • Vineland Adaptive Behavior Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 adaptive behavior score.


Other Outcome Measures:
  • Parent child interaction as measured by the Maternal Behavior Rating Scales and the Child Behavior Rating Scales [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The Maternal Behavior Rating Scale (MBRS) is a video rating scale that assesses four Interactive Style Factors including: Responsive/Child Oriented; Affect/Animation; Achievement Orientation; and Directiveness (Aim 1, Outcomes 1-3). Factors are assessed by rating twelve (5 point Likert-scaled) items during a 7 ½ minute video of typical parent-child play with toys.

    Pivotal Behavior Rating Scale (Mahoney & Wheeden, 1998; 1999. The PBRS measures contingent, reciprocal, social interactions. Factor analyses indicate the PBRS measures two components of interactive behavior - Attention and Initiation. The child's primary caregiver is asked to play with the child for 7 ½ minutes using a standard set of toys.



Enrollment: 112
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other Names:
  • PLAY
  • P.L.A.Y. Project
Active Comparator: 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.
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
Other Name: Special education preschool

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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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.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01768806

Locations
United States, Michigan
Ann Arbor Center for Developmental and Behavioral Pediatrics
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
Richard Solomon MD, Plc
Michigan State University
Investigators
Principal Investigator: Richard Solomon, MD Richard Solomon MD, Plc
  More Information

No publications provided

Responsible Party: Richard Solomon MD, Plc
ClinicalTrials.gov Identifier: NCT01768806     History of Changes
Other Study ID Numbers: 3125511, 2R44MH078431-02A1
Study First Received: January 12, 2013
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Richard Solomon MD, Plc:
Autism
Autism Spectrum Disorder
PLAY and Language for Autistic Youngsters
Intensive Early Intervention
Parent Training

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 20, 2014