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NCT01178385 · ClinicalTrials.gov registry record · Phase 2
Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
A Phase 2 study of Autism and Obsessive - Compulsive Disorder, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT01178385 is a Phase 2 study of Autism and Obsessive - Compulsive Disorder that has completed, run by University of South Florida. The registered enrollment target is 45 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01178385, a Phase 2 study of Autism and Obsessive - Compulsive Disorder, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Although effective interventions have been developed for typically developing youth with anxiety disorders, this approach needs to be adapted for children with autism. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with autism spectrum disorders and comorbid anxiety disorder(s).
Conditions Studied
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Cognitive-behavioral therapy
Study Locations (1)
Florida
- Rothman Center for Neuropsychiatry, University of South Florida - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01178385
The ClinicalTrials.gov registry entry for NCT01178385 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (75% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT01178385 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01178385 about?
NCT01178385 is a clinical study titled "Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders". Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. ...
What is the current status of trial NCT01178385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2010-04. Estimated completion is 2012-12.
What conditions does trial NCT01178385 study?
This clinical trial studies the following conditions: Autism, Obsessive - Compulsive Disorder, Generalized Anxiety Disorder, Social Phobia, Asperger's Syndrome.
What interventions are being tested in trial NCT01178385?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Cognitive-behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01178385?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01178385 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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