CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
Cognitive-behavioral therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01178385
NCT01178385Phase 3Completed

Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders

University of South Florida·interventional·Posted Aug 10, 2010·Updated Apr 2, 2013

In Brief

A Phase 3 clinical trial evaluating Cognitive-behavioral therapy and Treatment as Usual for Autism and 5 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.9 years ago

Interventions

Cognitive-behavioral therapybehavioral

Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA 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 exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.

Treatment as Usualbehavioral

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.