Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
|ClinicalTrials.gov Identifier: NCT01563003|
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : April 17, 2015
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Autism Asperger's Syndrome Pervasive Developmental Disorder Not Otherwise Specified Generalized Anxiety Disorder Social Phobia Separation Anxiety Disorder Obsessive-compulsive Disorder||Other: Cognitive Behavioral Therapy Other: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Cognitive Behavioral Therapy Condition
This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Other: Cognitive Behavioral Therapy
This condition involves 16 weekly CBT sessions.
Active Comparator: Treatment as Usual
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Other: Treatment as usual
This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
- Pediatric Anxiety Rating Scale [ Time Frame: After an average of 16 weeks (Post-treatment) ]Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
- Anxiety Disorders Interview Schedule Clinical Severity Rating [ Time Frame: After an average of 16 weeks (Post-treatment) ]Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.
- Clinical Global Impression - Severity Scale [ Time Frame: After an average of 16 weeks (Post-treatment) ]Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563003
|United States, Florida|
|Rothman Center for Neuropsychiatry|
|St. Petersburg, Florida, United States, 33701|