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NCT01177969 · ClinicalTrials.gov registry record · Phase 1
Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
A Phase 1 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01177969: Completed Phase 1 study, sponsored by University of South Florida.
NCT01177969 is a Phase 1 study that has completed, run by University of South Florida. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177969, a Phase 1 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy
- BEHAVIORAL Wait-list
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01177969 record still lists
NCT01177969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive-Behavioral Therapy is the first listed.
NCT01177969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01177969 about?
NCT01177969 is a clinical study titled "Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents". 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...
What is the current status of trial NCT01177969?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2009-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01177969?
The interventions under investigation include: Cognitive-Behavioral Therapy (BEHAVIORAL), Wait-list (BEHAVIORAL).
Who is sponsoring clinical trial NCT01177969?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01177969's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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