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Clinical Trials/NCT02147236
NCT02147236
Completed
N/A

A Randomized Trial of a Structured Social Skills Development Progam for Children With Autism Spectrum Disorders

Yale University1 site in 1 country44 target enrollmentJuly 2003

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pervasive Developmental Disorders
Sponsor
Yale University
Enrollment
44
Locations
1
Primary Endpoint
Clinical Global Impression for Improvement
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.

Detailed Description

This project is designed to evaluate the acceptability and initial efficacy of a structured group treatment intervention for enhancing social behavior in 40 children with autism spectrum disorders (ASDs). An important long-term goal of this project was to develop a model for delivery of social skills training that could be tested in a larger trial and ultimately exported to schools and community settings. To accomplish these aims, we designed a randomized clinical trial to evaluate a structured social skills program for school age children with pervasive developmental disorders (PDDs)compared to a Wait List control group. Specific aims included gathering preliminary evidence on the efficacy of the intervention on various parent measures of behavior, as well as an assessment of overall social functioning by an independent rater who would be blind to treatment assignment. The Social Skills Development program uses semi-structured activities and peer tutors to promote interpersanal skills. To evaluate acceptability of the program, we planned to track attendance, attrition and parent satisfaction in the trial. Finally, to evaluate the durability of gains achieved during the Social Skills Development program, we re-assessed the subjects initially randomized to the active treatment group at 9 months post-treatment.

Registry
clinicaltrials.gov
Start Date
July 2003
End Date
January 2005
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 8 to 11 years
  • Full Scale IQ score \> 70
  • PDD diagnosis (autism, Asperger's, PDD-Not Otherwise Specified)

Exclusion Criteria

  • concurrent, untreated psychiatric disorder(such as anxiety, depression or conduct disorder)

Outcomes

Primary Outcomes

Clinical Global Impression for Improvement

Time Frame: 16 weeks

Secondary Outcomes

  • Social Competence Inventory(16 weeks)

Study Sites (1)

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