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Group Treatment for Adolescents With Depression

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ClinicalTrials.gov Identifier: NCT02115737
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 16, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 16, 2014
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02115737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • The Adverse Childhood Experiences [ Time Frame: Assessed at baseline ]
    Used to measure adverse events that have happened up until the 18th year of life
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • The Adverse Childhood Experiences [ Time Frame: Assessed at baseline ]
    Used to measure adverse events that have happened up until the 18th year of life
  • The Children's Affective Liability 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
  • 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
  • The DBT Ways of Coping Checklist [ Time Frame: Change for baseline to endpoint (assessed at weeks 0, 4, 12, and 24) ]
    Used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Treatment for Adolescents With Depression
Official Title  ICMJE Group Treatment for Adolescents With Depression
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Dialectical Behavior Therapy Skills Group
  • Behavioral: Psychoeducation group treatment
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Dialectical Behavior Therapy Skills Group
  • 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
    Intervention: Behavioral: Psychoeducation group treatment
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2014)
60
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
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 NCT02115737
Other Study ID Numbers  ICMJE 213-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin I Goldstein, MD Sunnybrook Health Science Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date November 2015

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