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

Tracking Information

First Received Date ^ICMJE

October 30, 2009

Last Updated Date

October 30, 2009

Start Date ^ICMJE

February 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Community Clinic Test of Youth Anxiety Treatment

Official Title ^ICMJE

Community Clinic Test of Youth Anxiety and Depression Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety
Depression

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria:

Pervasive developmental disorder
Psychotic disorder
Mental retardation

Gender

Both

Ages

8 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01005836

Other Study ID Numbers ^ICMJE

R01MH57347

Has Data Monitoring Committee

Yes

Responsible Party

John R. Weisz, Judge Baker Children's Center/Harvard Medical School

Study Sponsor ^ICMJE

Harvard University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John R Weisz, PhD

Harvard University

Information Provided By

Harvard University

Verification Date

October 2009

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

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