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

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder
• Intervention / Treatment: Behavioral: cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Cognitive behavioral therapy	Behavioral: cognitive behavioral therapy; 1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
NO_INTERVENTION: 2; Waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician's Global Impressions-Improvement (CGI) scale	Posttreatment / postwaitlist

Secondary Outcome Measures

Outcome Measure	Time Frame
Anxiety Disorders Interview Schedule IV: Child and Parent Version	Posttreatment / postwaitlist

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Jeffrey J Wood, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: December 5, 2007
• First Submitted That Met QC Criteria: December 5, 2007
• First Posted (ESTIMATE): December 7, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; anxiety disorders; school-based intervention; randomized, controlled trial
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Anxiety, Separation
• Other Study ID Numbers: G04-06-117-04