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
  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 Phase
Anxiety
Depression
Behavioral: Cognitive behavioral therapy for youth anxiety
Other: Usual clinic care
Behavioral: Cognitive behavioral treatment for youth depression
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Harvard University:

Enrollment: 105
Study Start Date: February 1998
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

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01005836

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John R. Weisz, Judge Baker Children's Center/Harvard Medical School
ClinicalTrials.gov Identifier: NCT01005836     History of Changes
Other Study ID Numbers: R01MH57347
Study First Received: October 30, 2009
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014