Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings (KATES)
Primary Purpose
Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Separation Anxiety Disorder focused on measuring cognitive behavioral therapy, anxiety disorders, school-based intervention, randomized, controlled trial
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Cognitive behavioral therapy
Waitlist
Outcomes
Primary Outcome Measures
Clinician's Global Impressions-Improvement (CGI) scale
Secondary Outcome Measures
Anxiety Disorders Interview Schedule IV: Child and Parent Version
Full Information
NCT ID
NCT00569829
First Posted
December 5, 2007
Last Updated
March 28, 2012
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT00569829
Brief Title
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings
Acronym
KATES
Official Title
A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia
Keywords
cognitive behavioral therapy, anxiety disorders, school-based intervention, randomized, controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
Waitlist
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
Primary Outcome Measure Information:
Title
Clinician's Global Impressions-Improvement (CGI) scale
Time Frame
Posttreatment / postwaitlist
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule IV: Child and Parent Version
Time Frame
Posttreatment / postwaitlist
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Wood, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings
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