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Cognitive Behavioral Therapy for Early-Onset Depression

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dysthymic Disorder Behavioral: Cognitive Behavioral Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
Study Start Date : June 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Behavioral: Cognitive Behavioral Therapy
    Cognitive behaviour versus standard care

Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis on structured interview [ Time Frame: pre and post-intervention ]
  2. Children's Depression Inventory score [ Time Frame: pre- and post-intervention ]

Secondary Outcome Measures :
  1. Multidimensional Anxiety Scale for Children [ Time Frame: pre- and post-intervention ]
  2. Children's Global Assessment Scale [ Time Frame: pre- and post-intervention ]
  3. Brief Family Assessment Measure [ Time Frame: pre- and post-intervention ]
  4. Perceived Competence Scale for Children [ Time Frame: pre- and post-intervention ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096642


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

Publications:

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Responsible Party: Katharina Manassis, MD, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00096642    
Other Study ID Numbers: CBT DEP
Ethics # 138/2001
First Posted: November 15, 2004    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011
Keywords provided by Centre for Addiction and Mental Health:
cognitive behavioral therapy
depression
group therapy
parenting
children and adolescents
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
 Pathologic Processes
Mood Disorders
Mental Disorders