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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00096642
Other study ID # CBT DEP
Secondary ID Ethics # 138/200
Status Completed
Phase N/A
First received November 12, 2004
Last updated August 4, 2011
Start date June 2002
Est. completion date June 2006

Study information

Verified date August 2011
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Depression is a debilitating illness affecting large numbers of young people. 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. By studying the role of parental involvement, we hope to develop more effective treatments for depressed children and teens in the future.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 17 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive Behavioral Therapy
Cognitive behaviour versus standard care

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis on structured interview pre and post-intervention No
Primary Children's Depression Inventory score pre- and post-intervention No
Secondary Multidimensional Anxiety Scale for Children pre- and post-intervention No
Secondary Children's Global Assessment Scale pre- and post-intervention No
Secondary Brief Family Assessment Measure pre- and post-intervention No
Secondary Perceived Competence Scale for Children pre- and post-intervention No
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