- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00096642
Cognitive Behavioral Therapy for Early-Onset Depression
Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression is a debilitating illness affecting large numbers of young people. Psychotherapy approaches have shown some promise in teens, but few studies have examined these interventions when offered in a group format. The role of parents in treatment outcome has also received little attention.
In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group to help them better manage their depressed children and teens. We will randomly assign children to CBT with or without parental involvement. We hope to show that involving parents results in additional improvements in the children. We will also study factors that predict which children do best in treatment, and maintenance of gains at 6 month and 1 year follow-up. These findings will allow us to provide more effective treatments to depressed children and teens in the future.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children and adolescents meeting DSM-IV criteria for either Major Depression or Dysthymic Disorder.
Exclusion Criteria:
- Psychotic,
- Actively suicidal,
- IQ less than 80,
- Unable to speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnosis on structured interview
Time Frame: pre and post-intervention
|
pre and post-intervention
|
|
Children's Depression Inventory score
Time Frame: pre- and post-intervention
|
pre- and post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Multidimensional Anxiety Scale for Children
Time Frame: pre- and post-intervention
|
pre- and post-intervention
|
|
Children's Global Assessment Scale
Time Frame: pre- and post-intervention
|
pre- and post-intervention
|
|
Brief Family Assessment Measure
Time Frame: pre- and post-intervention
|
pre- and post-intervention
|
|
Perceived Competence Scale for Children
Time Frame: pre- and post-intervention
|
pre- and post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Katharina Manassis, MD, Centre for Addiction and Mental Health
Publications and helpful links
General Publications
- Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. doi: 10.1097/00004583-199611000-00011.
- Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J. Childhood and adolescent depression: a review of the past 10 years. Part II. J Am Acad Child Adolesc Psychiatry. 1996 Dec;35(12):1575-83. doi: 10.1097/00004583-199612000-00008.
- Birmaher B, Brent DA, Kolko D, Baugher M, Bridge J, Holder D, Iyengar S, Ulloa RE. Clinical outcome after short-term psychotherapy for adolescents with major depressive disorder. Arch Gen Psychiatry. 2000 Jan;57(1):29-36. doi: 10.1001/archpsyc.57.1.29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT DEP
- Ethics # 138/2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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