Clinical Trial: Bending Adolescent Depression Trajectories Through Personalized Prevention

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Bending Adolescent Depression Trajectories Through Personalized Prevention

Brief Summary: This project, which will innovatively combine risk factor research and evidence-based prevention programs, will advance knowledge on personalized approaches to prevention that may be able to better"bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will deliver equal doses of IPT-AST and CWS for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.

Detailed Summary:
Sponsor: Rutgers University

Current Primary Outcome:

  • Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) [ Time Frame: Post intervention (approximately 3 months post baseline) ]
    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
  • Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) [ Time Frame: 6-months post-intervention ]
    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
  • Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) [ Time Frame: 12-months post-intervention ]
    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
  • Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) [ Time Frame: 18-months post-intervention ]
    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
  • Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) [ Time Frame: 24-months post-intervention ]
    Presence of a depression diag

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Children's Depression Inventory (CDI) [ Time Frame: Post intervention (approximately 3 months after baseline) ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 6-months post-intervention ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 12-months post-intervention ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 18-months post-intervention ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 24-months post-intervention ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 30-months post-intervention ]
      Self-reported depression scores
    • Children's Depression Inventory (CDI) [ Time Frame: 36-months post-intervention ]
      Self-reported depression scores
    • Children's Global Assessment Scale (CGAS) [ Time Frame: Post Intervention (approximately 3 months following baseline) ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 6-months followup ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 12-months followup ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 18-months followup ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 24-months followup ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 30-months followup ]
      Assesses global functioning
    • Children's Global Assessment Scale (CGAS) [ Time Frame: 36-months followup ]
      Assesses global functioning


    Original Secondary Outcome: Same as current

    Information By: Rutgers University

    Dates:
    Date Received: September 18, 2013
    Date Started: September 2013
    Date Completion: August 2018
    Last Updated: April 10, 2017
    Last Verified: April 2017