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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00569829
First received: December 5, 2007
Last updated: March 28, 2012
Last verified: March 2012

December 5, 2007
March 28, 2012
January 2004
June 2008   (final data collection date for primary outcome measure)
Clinician's Global Impressions-Improvement (CGI) scale [ Time Frame: Posttreatment / postwaitlist ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00569829 on ClinicalTrials.gov Archive Site
Anxiety Disorders Interview Schedule IV: Child and Parent Version [ Time Frame: Posttreatment / postwaitlist ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Separation Anxiety Disorder
  • Generalized Anxiety Disorder
  • Social Phobia
Behavioral: cognitive behavioral therapy
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
  • Experimental: 1
    Cognitive behavioral therapy
    Intervention: Behavioral: cognitive behavioral therapy
  • No Intervention: 2
    Waitlist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2009
June 2008   (final data collection date for primary outcome measure)

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.
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00569829
G04-06-117-04
No
Jeffrey J. Wood, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Jeffrey J Wood, PhD University of California, Los Angeles
University of California, Los Angeles
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP