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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
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

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

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 5, 2007
    Last Updated
    March 28, 2012
    Sponsor
    University of California, Los Angeles
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    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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