Clinical trial NCT00096642: Cognitive Behavioral Therapy for Early-Onset Depression
Official title: Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Dysthymic Disorder
Keywords: cognitive behavioral therapy
depression
group therapy
parenting
children and adolescents
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2004-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Diagnosis on structured interview
timeFrame: pre and post-intervention
measure: Children's Depression Inventory score
timeFrame: pre- and post-intervention
Secondary outcomes:
measure: Multidimensional Anxiety Scale for Children
timeFrame: pre- and post-intervention
measure: Children's Global Assessment Scale
timeFrame: pre- and post-intervention
measure: Brief Family Assessment Measure
timeFrame: pre- and post-intervention
measure: Perceived Competence Scale for Children
timeFrame: pre- and post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Katharina Manassis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.