Cognitive Behavioral Therapy for Early-Onset Depression
Primary Purpose
Major Depressive Disorder, Dysthymic Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring cognitive behavioral therapy, depression, group therapy, parenting, children and adolescents
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
Sites / Locations
- Centre for Addiction and Mental Health
Outcomes
Primary Outcome Measures
Diagnosis on structured interview
Children's Depression Inventory score
Secondary Outcome Measures
Multidimensional Anxiety Scale for Children
Children's Global Assessment Scale
Brief Family Assessment Measure
Perceived Competence Scale for Children
Full Information
NCT ID
NCT00096642
First Posted
November 12, 2004
Last Updated
August 4, 2011
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT00096642
Brief Title
Cognitive Behavioral Therapy for Early-Onset Depression
Official Title
Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymic Disorder
Keywords
cognitive behavioral therapy, depression, group therapy, parenting, children and adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Cognitive behaviour versus standard care
Primary Outcome Measure Information:
Title
Diagnosis on structured interview
Time Frame
pre and post-intervention
Title
Children's Depression Inventory score
Time Frame
pre- and post-intervention
Secondary Outcome Measure Information:
Title
Multidimensional Anxiety Scale for Children
Time Frame
pre- and post-intervention
Title
Children's Global Assessment Scale
Time Frame
pre- and post-intervention
Title
Brief Family Assessment Measure
Time Frame
pre- and post-intervention
Title
Perceived Competence Scale for Children
Time Frame
pre- and post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Manassis, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
8936909
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. doi: 10.1097/00004583-199611000-00011.
Results Reference
background
PubMed Identifier
8973063
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. doi: 10.1097/00004583-199612000-00008.
Results Reference
background
PubMed Identifier
10632230
Citation
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. doi: 10.1001/archpsyc.57.1.29.
Results Reference
background
Links:
URL
http://www.aacap.org
Description
Website of American Academy of Child & Adolescent Psychiatry
Learn more about this trial
Cognitive Behavioral Therapy for Early-Onset Depression
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