Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01177969
Brief Summary:
Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.
Detailed Description:
Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence.
Initial protocol development efforts will focus on adapting relevant treatment elements from an effective CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Thereafter, protocol and measure development will be refined during Phases I and II of this study through our experiences treating a total of 20 young adolescents (ages 11-14 years - 10 will be treated at USF; 10 at University of California, Los Angeles (UCLA)) with ASD and comorbid anxiety disorder(s). The CBT protocol will then be examined in a trial comparing CBT to a waitlist condition (N = 32 total; 16 at each study site).
The two recruitment sites for this study are the University of California, Los Angeles and the University of South Florida. The University of Miami will assist with quality assurance checks. Considering the rising number of youth diagnosed with ASD, and the lack of tested treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts.
Study:
NCT01177969
Study Brief:
Protocol Section:
NCT01177969