Social Skills in Children With Autism Spectrum Disorders (SSD_ASD)
Primary Purpose
Pervasive Developmental Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Pervasive Developmental Disorders focused on measuring autism, pervasive developmental disorders, social skills intervention
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)
Sites / Locations
- Yale Child Study Center
Outcomes
Primary Outcome Measures
Clinical Global Impression for Improvement
Secondary Outcome Measures
Social Competence Inventory
Full Information
NCT ID
NCT02147236
First Posted
May 21, 2014
Last Updated
May 21, 2014
Sponsor
Yale University
Collaborators
Organization of Autism Research, Renfield Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02147236
Brief Title
Social Skills in Children With Autism Spectrum Disorders
Acronym
SSD_ASD
Official Title
A Randomized Trial of a Structured Social Skills Development Progam for Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Organization of Autism Research, Renfield Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pervasive Developmental Disorders
Keywords
autism, pervasive developmental disorders, social skills intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Primary Outcome Measure Information:
Title
Clinical Global Impression for Improvement
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Social Competence Inventory
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence D Scahill, MSN,PhD
Organizational Affiliation
Yale University Child Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Social Skills in Children With Autism Spectrum Disorders
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