Cognitive Behavioral Therapy for Early-Onset Depression

• ClinicalTrials.gov Identifier: NCT00096642
• Recruitment Status: Completed
• First Posted: November 15, 2004
• Last Update Posted: August 5, 2011
• Sponsor: Centre for Addiction and Mental Health
• Information provided by: Centre for Addiction and Mental Health

Tracking Information

• First Submitted Date: November 12, 2004
• First Posted Date: November 15, 2004
• Last Update Posted Date: August 5, 2011
• Study Start Date: June 2002
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2011)

• Diagnosis on structured interview [ Time Frame: pre and post-intervention ]
• Children's Depression Inventory score [ Time Frame: pre- and post-intervention ]

Original Primary Outcome Measures (submitted: June 23, 2005)

• Diagnosis on structured interview
• Children's Depression Inventory score

Current Secondary Outcome Measures (submitted: August 4, 2011)

• Multidimensional Anxiety Scale for Children [ Time Frame: pre- and post-intervention ]
• Children's Global Assessment Scale [ Time Frame: pre- and post-intervention ]
• Brief Family Assessment Measure [ Time Frame: pre- and post-intervention ]
• Perceived Competence Scale for Children [ Time Frame: pre- and post-intervention ]

Original Secondary Outcome Measures (submitted: June 23, 2005)

• Multidimensional Anxiety Scale for Children
• Children's Global Assessment Scale
• Brief Family Assessment Measure
• Perceived Competence Scale for Children

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Behavioral Therapy for Early-Onset Depression
• Official Title: Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
• Brief 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.

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Major Depressive Disorder
• Dysthymic Disorder

Intervention

Behavioral: Cognitive Behavioral Therapy

Cognitive behaviour versus standard care

• Study Arms: Not Provided

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. Review.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2011): 30
• Original Enrollment (submitted: June 23, 2005): 90
• Actual Study Completion Date: June 2006
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00096642
• Other Study ID Numbers: CBT DEP; Ethics # 138/2001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Katharina Manassis, MD, Centre for Addiction and Mental Health
• Study Sponsor: Centre for Addiction and Mental Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: Katharina Manassis, MD; Centre for Addiction and Mental Health

• PRS Account: Centre for Addiction and Mental Health
• Verification Date: August 2011