Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
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|ClinicalTrials.gov Identifier: NCT01919970|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : October 26, 2017
|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 Specific Phobia||Other: Cognitive Behavioral Therapy Other: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2017|
Experimental: Cognitive Behavioral Therapy Condition
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Other: Cognitive Behavioral Therapy
This condition involves 12 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 12 weeks (post-treatment) ]
- Clinical Global Impression - Severity Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ]
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): NCT01919970
|United States, Florida|
|Rothman Center for Neuropsychiatry|
|Saint Petersburg, Florida, United States, 33701|