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Community Clinic Test of Youth Anxiety Treatment (YADS)

P

President and Fellows of Harvard College

Status

Completed

Conditions

Depression
Anxiety

Treatments

Other: Usual clinic care
Behavioral: Cognitive behavioral therapy for youth anxiety
Behavioral: Cognitive behavioral treatment for youth depression

Study type

Interventional

Funder types

Other

Identifiers

NCT01005836
R01MH057347

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

8 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary DSM-IV anxiety or depressive disorder

Exclusion criteria

  • Pervasive developmental disorder
  • Psychotic disorder
  • Mental retardation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

105 participants in 4 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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