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Cognitive Behavioral Therapy for Early-Onset Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 12, 2004
First Posted Date  ICMJE November 15, 2004
Last Update Posted Date August 5, 2011
Study Start Date  ICMJE June 2002
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: June 23, 2005)
  • Diagnosis on structured interview
  • Children's Depression Inventory score
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Cognitive Behavioral Therapy for Early-Onset Depression
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Dysthymic Disorder
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy
Cognitive behaviour versus standard care
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2011)
30
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
90
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00096642
Other Study ID Numbers  ICMJE CBT DEP
Ethics # 138/2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katharina Manassis, MD, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katharina Manassis, MD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP