Bending Adolescent Depression Trajectories Through Personalized Prevention

NCT ID: NCT01948167

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interpersonal Psychotherapy- Adolescent Skills Training

Interpersonal Psychotherapy- Adolescent Skills Training

Group Type EXPERIMENTAL

Interpersonal Psychotherapy- Adolescent Skills Training

Intervention Type BEHAVIORAL

A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.

Coping with Stress

Coping with Stress

Group Type EXPERIMENTAL

Coping with Stress

Intervention Type BEHAVIORAL

A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.

Interventions

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Interpersonal Psychotherapy- Adolescent Skills Training

A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.

Intervention Type BEHAVIORAL

Coping with Stress

A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.

Intervention Type BEHAVIORAL

Other Intervention Names

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IPT-AST Teen Talk CWS

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Denver

OTHER

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jami F Young, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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University of Denver

Denver, Colorado, United States

Site Status

University of Illinois Urbana Champaign

Champaign, Illinois, United States

Site Status

Rutgers University

Piscataway, New Jersey, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Jones JD, Schwartz KTG, Davis M, Gallop R, Hankin BL, Young JF. Cognitive and interpersonal moderators of two evidence-based depression prevention programs. J Consult Clin Psychol. 2024 Jul;92(7):432-444. doi: 10.1037/ccp0000886. Epub 2024 Apr 18.

Reference Type DERIVED
PMID: 38635190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33189876 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01MH077178

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-013831

Identifier Type: -

Identifier Source: org_study_id

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