Community Clinic Test of Youth Anxiety Treatment

NCT ID: NCT01005836

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28
• Study Completion Date: 2005-05-31

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.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cognitive-behavioral therapy: Anxiety

CBT for child anxiety. Coping Cat.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for youth anxiety

Intervention Type: BEHAVIORAL

Usual care: Anxiety

Usual clinic care

Group Type: OTHER

Usual clinic care

Intervention Type: OTHER

Cognitive behavioral therapy: depression

CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.

Group Type: EXPERIMENTAL

Cognitive behavioral treatment for youth depression

Intervention Type: BEHAVIORAL

Usual care: Depression

Usual clinic care for depression

Group Type: OTHER

Usual clinic care

Intervention Type: OTHER

Interventions

Cognitive behavioral therapy for youth anxiety

Intervention Type: BEHAVIORAL

Usual clinic care

Intervention Type: OTHER

Cognitive behavioral treatment for youth depression

Intervention Type: BEHAVIORAL

Other Intervention Names

Coping Cat; PASCET

Eligibility Criteria

Inclusion Criteria

• Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria

• Pervasive developmental disorder
• Psychotic disorder
• Mental retardation

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard University

OTHER

Sponsor Role: lead

Responsible Party

John Weisz

Professor and Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John R Weisz, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

References

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.

Reference Type: RESULT

PMID: 19485581 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20855049 (View on PubMed)

Other Identifiers

R01MH057347

Identifier Type: NIH

Identifier Source: org_study_id

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