NCT00096642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

November 12, 2004

Last Update Submit

August 4, 2011

Conditions

Major Depressive DisorderDysthymic Disorder

Keywords

cognitive behavioral therapydepressiongroup therapyparentingchildren and adolescents

Outcome Measures

Primary Outcomes (2)

  • Diagnosis on structured interview

    pre and post-intervention

  • Children's Depression Inventory score

    pre- and post-intervention

Secondary Outcomes (4)

  • Multidimensional Anxiety Scale for Children

    pre- and post-intervention

  • Children's Global Assessment Scale

    pre- and post-intervention

  • Brief Family Assessment Measure

    pre- and post-intervention

  • Perceived Competence Scale for Children

    pre- and post-intervention

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Cognitive behaviour versus standard care

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents meeting DSM-IV criteria for either Major Depression or Dysthymic Disorder.

You may not qualify if:

  • Psychotic,
  • Actively suicidal,
  • IQ less than 80,
  • Unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 8936909BACKGROUND

  • 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.

    PMID: 8973063BACKGROUND

  • 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.

    PMID: 10632230BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Katharina Manassis, MD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2004

First Posted

November 15, 2004

Study Start

June 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

CA(1)