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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569829
First Posted: December 7, 2007
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles
  Purpose
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
Separation Anxiety Disorder Generalized Anxiety Disorder Social Phobia Behavioral: cognitive behavioral therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings

Resource links provided by NLM:


Further study details as provided by Jeffrey J. Wood, University of California, Los Angeles:

Primary Outcome Measures:
  • Clinician's Global Impressions-Improvement (CGI) scale [ Time Frame: Posttreatment / postwaitlist ]

Secondary Outcome Measures:
  • Anxiety Disorders Interview Schedule IV: Child and Parent Version [ Time Frame: Posttreatment / postwaitlist ]

Enrollment: 60
Study Start Date: January 2004
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569829


Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jeffrey J Wood, PhD University of California, Los Angeles
  More Information

Responsible Party: Jeffrey J. Wood, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00569829     History of Changes
Other Study ID Numbers: G04-06-117-04
First Submitted: December 5, 2007
First Posted: December 7, 2007
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by Jeffrey J. Wood, University of California, Los Angeles:
cognitive behavioral therapy
anxiety disorders
school-based intervention
randomized, controlled trial

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Phobic Disorders
Neurodevelopmental Disorders