Community Clinic Test of Youth Anxiety Treatment

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Cognitive behavioral therapy for youth anxiety; Other: Usual clinic care; Behavioral: Cognitive behavioral treatment for youth depression

• Registration Number: NCT01005836
• Lead Sponsor: Harvard University

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 available

Study Timeline

• Study Start: 1998-02
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria

• Pervasive developmental disorder
• Psychotic disorder
• Mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioral therapy: Anxiety	Cognitive behavioral therapy for youth anxiety	CBT for child anxiety. Coping Cat.
Usual care: Depression	Usual clinic care	Usual clinic care for depression
Usual care: Anxiety	Usual clinic care	Usual clinic care
Cognitive behavioral therapy: depression	Cognitive behavioral treatment for youth depression	CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.