Clinical Trial: Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders

Brief Summary: This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.

Detailed Summary:

Autism spectrum disorders (ASDs) are developmental disorders with similar features, including problems communicating, problems interacting socially, and the presence of routines or repetitive behaviors. These disorders can have a range of severities. They include autistic disorder, Asperger's syndrome, and pervasive developmental disorder not otherwise specified (PDD-NOS). In addition to their core impairment in social functioning, children and adolescents with ASDs often have anxiety about social interactions, which compounds their difficulties and can limit the benefits of treatment. This study will develop and test a treatment program for developing social skills and reducing anxiety in children and adolescents with ASDs.

Participation in this study will last 12 to 14 weeks, with follow-up visits occurring 3 and 12 months after that. Participants will be randomly assigned to receive the treatment program either immediately or after being on a wait list. The treatment program will consist of 12 to 14 weekly individual therapy sessions that teach children and adolescents about ASDs, use cognitive-behavioral interventions to address problematic thinking and acting, deliver social skills instruction, and give opportunities to practice skills—including some practice outside the clinic in naturalistic settings. Every 2 weeks, starting at Week 4, children and adolescents will also attend group sessions to discuss strategies and practice social skills. Parents of the participants will be included at the end of each individual session for several minutes. After the participants assigned to immediate treatment complete the program, participants from the wait list will be offered the treatment.

Child and adolescent participants and their parents will complete assessments at baseline, midpoint in treatment, post-treatment (We
Sponsor: Virginia Polytechnic Institute and State University

Current Primary Outcome: Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and 3-month follow-up ]

Original Primary Outcome: Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and a 3-month follow-up ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Virginia Polytechnic Institute and State University

Dates:
Date Received: June 22, 2009
Date Started: September 2008
Date Completion:
Last Updated: November 6, 2013
Last Verified: November 2013