- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01005836
Community Clinic Test of Youth Anxiety Treatment (YADS)
March 28, 2017 updated by: John Weisz, Harvard University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary DSM-IV anxiety or depressive disorder
Exclusion Criteria:
- Pervasive developmental disorder
- Psychotic disorder
- Mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive-behavioral therapy: Anxiety
CBT for child anxiety.
Coping Cat.
|
Other Names:
|
|
Other: Usual care: Anxiety
Usual clinic care
|
|
|
Experimental: Cognitive behavioral therapy: depression
CBT for youth depression.
The Primary and Secondary Control Enhancement Training protocol.
|
Other Names:
|
|
Other: Usual care: Depression
Usual clinic care for depression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R Weisz, PhD, Harvard University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1998
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
October 30, 2009
First Submitted That Met QC Criteria
October 30, 2009
First Posted (Estimate)
November 1, 2009
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH057347 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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