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

Generalized Anxiety Disorder Clinical Trial

— KATES  

Official title:

A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569829
• Other study ID #: G04-06-117-04
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: March 28, 2012
• Start date: January 2004
• Est. completion date: June 2009

Study information

• Verified date: March 2012
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Separation Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• cognitive behavioral therapy
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician's Global Impressions-Improvement (CGI) scale		Posttreatment / postwaitlist	No
Secondary	Anxiety Disorders Interview Schedule IV: Child and Parent Version		Posttreatment / postwaitlist	No