Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings

Phase 2

Completed

• Conditions: Separation Anxiety Disorder; Generalized Anxiety Disorder; Social Phobia
• Interventions: Behavioral: cognitive behavioral therapy

• Registration Number: NCT00569829
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-07
• Primary Completion: 2008-06
• Study Completion: 2009-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The child meets DSM-IV criteria for separation anxiety disorder (SAD), social phobia, or generalized anxiety disorder (GAD) based on a diagnostic interview
• The child is not taking any psychiatric medication at the initial assessment, or is taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment)
• If medication is being used, children will maintain that dose throughout the study

Exclusion Criteria

• The child is currently in psychotherapy
• The family is currently in family therapy or a parenting class
• The child begins taking psychiatric medication or increases his/her dose of medication during the intervention
• For any reason the child or parents appear unable to participate in the intervention program.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cognitive behavioral therapy	Cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Clinician's Global Impressions-Improvement (CGI) scale	Posttreatment / postwaitlist

Secondary Outcome Measures

Name	Time	Method
Anxiety Disorders Interview Schedule IV: Child and Parent Version	Posttreatment / postwaitlist