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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: Completed Phase 2 study of Autism and Obsessive - Compulsive Disorder, sponsored by University of South Florida.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.

Conditions Studied

Autism Obsessive - Compulsive Disorder Generalized Anxiety Disorder Social Phobia Asperger's Syndrome Separation Anxiety Disorder

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

FieldValue
Enrollment Target 45 participants
Start Date 2010-04
Est. Completion 2012-12
Phase Phase 2
University of South Florida

252 total trials

What the finished NCT01178385 record still lists

NCT01178385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (75% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Autism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01178385's enrollment target sits among peer trials

45 58th of 104 higher than 46 of 104 other Autism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism 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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Related registry views

Source: ClinicalTrials.gov NCT01178385, the US trial registry maintained by the National Library of Medicine. NCT01178385 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.