Clinical trial NCT02147236: Social Skills in Children With Autism Spectrum Disorders
Official title: A Randomized Trial of a Structured Social Skills Development Progam for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pervasive Developmental Disorders
Keywords: autism
pervasive developmental disorders
social skills intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Organization of Autism Research
name: Renfield Foundation
First posted: 2014-05-26
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Clinical Global Impression for Improvement
timeFrame: 16 weeks
Secondary outcomes:
measure: Social Competence Inventory
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University Child Study Center
name: Lawrence D Scahill, MSN,PhD
role: PRINCIPAL_INVESTIGATOR
References: