Clinical trial NCT01948167: Bending Adolescent Depression Trajectories Through Personalized Prevention
Official title: Bending Adolescent Depression Trajectories Through Personalized Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Prevention
Adolescents
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Denver
name: Rutgers University
name: University of Illinois at Urbana-Champaign
First posted: 2013-09-23
Enrollment: 205
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Post intervention (approximately 3 months post baseline)
measure: 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)
timeFrame: 6-months post-intervention
measure: 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)
timeFrame: 12-months post-intervention
measure: 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)
timeFrame: 18-months post-intervention
measure: 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)
timeFrame: 24-months post-intervention
measure: 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)
timeFrame: 30-months post-intervention
measure: 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)
timeFrame: 36-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: Post intervention (approximately 3 months after baseline)
measure: Children's Depression Inventory (CDI)
timeFrame: 6-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: 12-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: 18-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: 24-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: 30-months post-intervention
measure: Children's Depression Inventory (CDI)
timeFrame: 36-months post-intervention
Secondary outcomes:
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Post Intervention (approximately 3 months following baseline)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 6-months followup
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 12-months followup
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 18-months followup
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 24-months followup
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 30-months followup
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 36-months followup
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
city: Champaign
country: United States
facility: University of Illinois Urbana Champaign
state: Illinois
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jami F Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young JF, Jones JD, Gallop R, Benas JS, Schueler CM, Garber J, Hankin BL. Personalized Depression Prevention: A Randomized Controlled Trial to Optimize Effects Through Risk-Informed Personalization. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1116-1126.e1. doi: 10.1016/j.jaac.2020.11.004. Epub 2020 Nov 13.