Social Skills in Children With Autism Spectrum Disorders

Pervasive Developmental Disorders Clinical Trial

— SSD_ASD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147236
• Other study ID #: 0402026356
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: May 21, 2014
• Start date: July 2003
• Est. completion date: January 2005

Study information

• Verified date: May 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Pervasive Developmental Disorders

Intervention

Behavioral:
• Social Skills Training

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Organization of Autism Research, Renfield Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression for Improvement		16 weeks
Secondary	Social Competence Inventory		16 weeks