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Community Clinic Test of Youth Anxiety Treatment (YADS)

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy for youth anxiety
Usual clinic care
Cognitive behavioral treatment for youth depression
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria:

  • Pervasive developmental disorder
  • Psychotic disorder
  • Mental retardation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Other

    Experimental

    Other

    Arm Label

    Cognitive-behavioral therapy: Anxiety

    Usual care: Anxiety

    Cognitive behavioral therapy: depression

    Usual care: Depression

    Arm Description

    CBT for child anxiety. Coping Cat.

    Usual clinic care

    CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.

    Usual clinic care for depression

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2009
    Last Updated
    March 28, 2017
    Sponsor
    Harvard University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01005836
    Brief Title
    Community Clinic Test of Youth Anxiety Treatment
    Acronym
    YADS
    Official Title
    Community Clinic Test of Youth Anxiety and Depression Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1998 (undefined)
    Primary Completion Date
    May 2005 (Actual)
    Study Completion Date
    May 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. But can these lab-tested treatments actually work in service-oriented clinics with referred youth? Available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. To assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. To help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: Kendall's (1994) cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The program has shown unusually positive effects across a series of clinical trials in the U.S. and Australia, but it has never been tested in real-world clinical conditions. The proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the Kendall program, carried out by clinic staff who have been trained to proficiency. Therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression
    Keywords
    Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-behavioral therapy: Anxiety
    Arm Type
    Experimental
    Arm Description
    CBT for child anxiety. Coping Cat.
    Arm Title
    Usual care: Anxiety
    Arm Type
    Other
    Arm Description
    Usual clinic care
    Arm Title
    Cognitive behavioral therapy: depression
    Arm Type
    Experimental
    Arm Description
    CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.
    Arm Title
    Usual care: Depression
    Arm Type
    Other
    Arm Description
    Usual clinic care for depression
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral therapy for youth anxiety
    Other Intervention Name(s)
    Coping Cat
    Intervention Type
    Other
    Intervention Name(s)
    Usual clinic care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral treatment for youth depression
    Other Intervention Name(s)
    PASCET

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary DSM-IV anxiety or depressive disorder Exclusion Criteria: Pervasive developmental disorder Psychotic disorder Mental retardation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John R Weisz, PhD
    Organizational Affiliation
    Harvard University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19485581
    Citation
    Weisz JR, Southam-Gerow MA, Gordis EB, Connor-Smith JK, Chu BC, Langer DA, McLeod BD, Jensen-Doss A, Updegraff A, Weiss B. Cognitive-behavioral therapy versus usual clinical care for youth depression: an initial test of transportability to community clinics and clinicians. J Consult Clin Psychol. 2009 Jun;77(3):383-96. doi: 10.1037/a0013877.
    Results Reference
    result
    PubMed Identifier
    20855049
    Citation
    Southam-Gerow MA, Weisz JR, Chu BC, McLeod BD, Gordis EB, Connor-Smith JK. Does cognitive behavioral therapy for youth anxiety outperform usual care in community clinics? An initial effectiveness test. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1043-52. doi: 10.1016/j.jaac.2010.06.009. Epub 2010 Jul 31.
    Results Reference
    derived

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    Community Clinic Test of Youth Anxiety Treatment

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