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Completed

NCT Number: NCT02147236

Social Skills in Children With Autism Spectrum Disorders

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Social Skills Training

Behavioral

Primary outcomes

  1. Clinical Global Impression for Improvement

    Time frame: 16 weeks

Secondary outcomes

  1. Social Competence Inventory

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Organization of Autism Research
  • Renfield Foundation

Registry information

Official study title

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

Acronym: SSD_ASD

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
May 26, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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