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Community Clinic Test of Youth Anxiety Treatment (YADS)

This study has been completed.
Sponsor:
Information provided by:
Harvard University
ClinicalTrials.gov Identifier:
NCT01005836
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 30, 2009
October 30, 2009
February 1998
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No Changes Posted
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Community Clinic Test of Youth Anxiety Treatment
Community Clinic Test of Youth Anxiety and Depression Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety
  • Depression
  • Behavioral: Cognitive behavioral therapy for youth anxiety
    Other Name: Coping Cat
  • Other: Usual clinic care
  • Behavioral: Cognitive behavioral treatment for youth depression
    Other Name: PASCET
  • Experimental: Cognitive-behavioral therapy: Anxiety
    CBT for child anxiety. Coping Cat.
    Intervention: Behavioral: Cognitive behavioral therapy for youth anxiety
  • Usual care: Anxiety
    Usual clinic care
    Intervention: Other: Usual clinic care
  • Experimental: Cognitive behavioral therapy: depression
    CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.
    Intervention: Behavioral: Cognitive behavioral treatment for youth depression
  • Usual care: Depression
    Usual clinic care for depression
    Intervention: Other: Usual clinic care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
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Inclusion Criteria:

  • Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria:

  • Pervasive developmental disorder
  • Psychotic disorder
  • Mental retardation
Both
8 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01005836
R01MH57347
Yes
John R. Weisz, Judge Baker Children's Center/Harvard Medical School
Harvard University
Not Provided
Principal Investigator: John R Weisz, PhD Harvard University
Harvard University
October 2009

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