Community Clinic Test of Youth Anxiety Treatment (YADS)
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy for youth anxiety
Usual clinic care
Cognitive behavioral treatment for youth depression
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care
Eligibility Criteria
Inclusion Criteria:
- Primary DSM-IV anxiety or depressive disorder
Exclusion Criteria:
- Pervasive developmental disorder
- Psychotic disorder
- Mental retardation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
Cognitive-behavioral therapy: Anxiety
Usual care: Anxiety
Cognitive behavioral therapy: depression
Usual care: Depression
Arm Description
CBT for child anxiety. Coping Cat.
Usual clinic care
CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.
Usual clinic care for depression
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01005836
Brief Title
Community Clinic Test of Youth Anxiety Treatment
Acronym
YADS
Official Title
Community Clinic Test of Youth Anxiety and Depression Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy: Anxiety
Arm Type
Experimental
Arm Description
CBT for child anxiety. Coping Cat.
Arm Title
Usual care: Anxiety
Arm Type
Other
Arm Description
Usual clinic care
Arm Title
Cognitive behavioral therapy: depression
Arm Type
Experimental
Arm Description
CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol.
Arm Title
Usual care: Depression
Arm Type
Other
Arm Description
Usual clinic care for depression
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for youth anxiety
Other Intervention Name(s)
Coping Cat
Intervention Type
Other
Intervention Name(s)
Usual clinic care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral treatment for youth depression
Other Intervention Name(s)
PASCET
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary DSM-IV anxiety or depressive disorder
Exclusion Criteria:
Pervasive developmental disorder
Psychotic disorder
Mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Weisz, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19485581
Citation
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.
Results Reference
result
PubMed Identifier
20855049
Citation
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.
Results Reference
derived
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Community Clinic Test of Youth Anxiety Treatment
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