Bending Adolescent Depression Trajectories Through Personalized Prevention

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT01948167
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.

Detailed Description

Investigators will innovatively combine risk factor research and evidence-based prevention programs, to 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 examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Currently in the 6th to 11th grades
• Adolescent and parent must be English-speaking
• Parental consent and adolescent consent

Exclusion Criteria

• Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
• Suicide attempt in the past week or significant suicidal ideation in the past week
• Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	36-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)	Post intervention (approximately 3 months post baseline)	Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Children's Depression Inventory (CDI)	36-months post-intervention	Self-reported depression scores

Secondary Outcome Measures

Name	Time	Method
Children's Global Assessment Scale (CGAS)	36-months followup	Assesses global functioning

Trial Locations

Locations (4)

University of Denver; 🇺🇸 Denver, Colorado, United States

University of Illinois Urbana Champaign; 🇺🇸 Champaign, Illinois, United States

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States