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Community Clinic Test of Youth Anxiety Treatment (YADS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005836
First Posted: November 2, 2009
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Weisz, Harvard University
  Purpose
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.

Condition Intervention
Anxiety Depression Behavioral: Cognitive behavioral therapy for youth anxiety Other: Usual clinic care Behavioral: Cognitive behavioral treatment for youth depression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Community Clinic Test of Youth Anxiety and Depression Study

Resource links provided by NLM:


Further study details as provided by John Weisz, Harvard University:

Enrollment: 105
Study Start Date: February 1998
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-behavioral therapy: Anxiety
CBT for child anxiety. Coping Cat.
Behavioral: Cognitive behavioral therapy for youth anxiety
Other Name: Coping Cat
Usual care: Anxiety
Usual clinic care
Other: Usual clinic care
Experimental: Cognitive behavioral therapy: depression
CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.
Behavioral: Cognitive behavioral treatment for youth depression
Other Name: PASCET
Usual care: Depression
Usual clinic care for depression
Other: Usual clinic care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria:

  • Pervasive developmental disorder
  • Psychotic disorder
  • Mental retardation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005836


Sponsors and Collaborators
Harvard University
Investigators
Principal Investigator: John R Weisz, PhD Harvard University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Weisz, Professor and Primary Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT01005836     History of Changes
Other Study ID Numbers: R01MH057347 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by John Weisz, Harvard University:
Cognitive behavioral therapy
Anxiety treatment
Depression treatment
Child treatment
Usual care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders