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Sponsored by: |
University of California, Los Angeles |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00569829 |
Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Clinical trials conducted in practice settings can demonstrate the degree to which evidence-based treatments are appropriate for larger scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in the elementary school clinic setting. A randomized, controlled trial design has been employed, comparing immediate treatment and a three-month waitlist. The trial is being conducted in several Los Angeles area elementary schools and is only available to children in these particular schools. To ensure that the CBT intervention is flexible and capable of matching the characteristics of various school settings, clinicians, and referred children, a modular treatment approach is employed. The study design includes elements to ensure high quality data, such as the use of independent evaluators and tests of treatment fidelity. Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a semi-structured diagnostic interview. Therapy and clinical supervision is provided by the research team. It is hypothesized that children receiving immediate treatment will have significantly lower anxiety scores than children assigned to the waitlist at the posttreatment/postwaitlist assessment. If results are favorable, further exploration of dissemination of CBT into school clinic settings may be indicated.
Condition | Intervention | Phase |
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Separation Anxiety Disorder Generalized Anxiety Disorder Social Phobia |
Behavioral: cognitive behavioral therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings |
Estimated Enrollment: | 60 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cognitive behavioral therapy
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Behavioral: cognitive behavioral therapy
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
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2: No Intervention
Waitlist
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Ages Eligible for Study: | 5 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UCLA ( Jeffrey J. Wood, Ph.D. ) |
Study ID Numbers: | G04-06-117-04 |
Study First Received: | December 5, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00569829 |
Health Authority: | United States: Institutional Review Board |
cognitive behavioral therapy anxiety disorders school-based intervention randomized, controlled trial |
Anxiety Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Anxiety, Separation Phobic Disorders |
Pathologic Processes Disease |