Cognitive Behavioral Therapy for Early-Onset Depression

This study has been completed.
Sponsor:
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00096642
First received: November 12, 2004
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dysthymic Disorder
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Diagnosis on structured interview [ Time Frame: pre and post-intervention ] [ Designated as safety issue: No ]
  • Children's Depression Inventory score [ Time Frame: pre- and post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multidimensional Anxiety Scale for Children [ Time Frame: pre- and post-intervention ] [ Designated as safety issue: No ]
  • Children's Global Assessment Scale [ Time Frame: pre- and post-intervention ] [ Designated as safety issue: No ]
  • Brief Family Assessment Measure [ Time Frame: pre- and post-intervention ] [ Designated as safety issue: No ]
  • Perceived Competence Scale for Children [ Time Frame: pre- and post-intervention ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive Behavioral Therapy
    Cognitive behaviour versus standard care
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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096642

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Katharina Manassis, MD Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
Responsible Party: Katharina Manassis, MD, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00096642     History of Changes
Other Study ID Numbers: CBT DEP, Ethics # 138/2001
Study First Received: November 12, 2004
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
cognitive behavioral therapy
depression
group therapy
parenting
children and adolescents

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Dysthymic Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014