- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115737
Group Treatment for Adolescents With Depression
November 16, 2015 updated by: Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
Youth with depressive symptoms are at risk for a range of problems later in life.
This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders.
The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth.
A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time.
Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group.
This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh.
The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking
- male or female, ages 14 to 19, all races and ethnicities
- Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
- Has a treating psychiatrist at Sunnybrook Health Sciences Centre
Exclusion Criteria:
- Current manic episode
- current psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dialectical Behavior Therapy Skills Group
Twelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path
|
|
|
Experimental: Psychoeducation group treatment
The comparison group used in the present study is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Depression Rating Scale - Revise (CDRS-R)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 12, 24)
|
Measure mood symptom severity.
Response is defined as greater than or equal to 50% reduction in CDRS-R score
|
Change from baseline to endpoint (assessed at weeks 0, 12, 24)
|
|
The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
|
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
|
Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Adverse Childhood Experiences
Time Frame: Assessed at baseline
|
Used to measure adverse events that have happened up until the 18th year of life
|
Assessed at baseline
|
|
The Children's Affective Lability Scale
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
|
Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment
|
Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
|
|
The Stressful Life Events Schedule
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
Used to ascertain 80 adolescent and parent reported negative life events, during the preceding year or time since last assessment
|
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
|
The DBT Ways of Coping Checklist
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
This is a self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
|
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
|
The Life Problems Inventory
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.
|
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin I Goldstein, MD, Sunnybrook Health Science Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
April 14, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (Estimate)
April 16, 2014
Study Record Updates
Last Update Posted (Estimate)
November 17, 2015
Last Update Submitted That Met QC Criteria
November 16, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 213-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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