Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT00926471|
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : November 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder Child Development Disorders, Pervasive||Behavioral: Cognitive Behavioral Therapy (CBT) Program||Phase 1|
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 (Week 12 or 14), and 3- and 12-month follow-ups. Participants assigned to the wait list condition will complete assessments only at baseline, before entering treatment (Week 12 or 14), and after completing treatment. Assessments will involve questionnaires about social and emotional functioning, interviews with study researchers, and surveys on satisfaction with the study. The child or adolescent's primary teacher will also complete questionnaires about the child.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||January 2013|
Experimental: Cognitive Behavioral Therapy (CBT) Program
Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
Behavioral: Cognitive Behavioral Therapy (CBT) Program
12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week
No Intervention: Wait list control
Participants will be placed on a 12-week wait list with no active treatment
- Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and 3-month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926471
|United States, Virginia|
|Virginia Polytechnic Institute and State University|
|Blacksburg, Virginia, United States, 24061|
|Principal Investigator:||Susan W White, PhD||Virginia Polytechnic Institute and State University|