Prevention of Depression in At-Risk Adolescents

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Depression Prevention Program for Adolescents

NCT00183417

Depression

COMPLETED NA

Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents

NCT00374439

Depressive Symptoms

COMPLETED NA

Family Cognitive Behavioral Therapy for Preventing Depression in Children

NCT00183482

Depression

COMPLETED NA

Predictors of Response to Treatment for Depression

NCT03154008

Adolescent Depression Depression

COMPLETED NA

Effect of Family-Based Prevention on Children of Depressed Parents

NCT00183365

Depression

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.

Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor were unaware of condition assignment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1= Cognitive behavioral prevention of depression program

Participants receive a group cognitive-behavioral prevention program, which involved 8 weekly sessions and 6 monthly sessions of CBT skills such as cognitive restructuring, problem-solving, assertivenss, and behavioral activation. Participants in this arm also were able to seek the same kinds of nonstudy treatments as described in the usual care arm.

Group Type EXPERIMENTAL

Cognitive-behavioral prevention program

Intervention Type BEHAVIORAL

Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.

2 = Usual care

Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Participants receive usual care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive-behavioral prevention program

Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.

Intervention Type BEHAVIORAL

Usual care

Participants receive usual care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A parent has had a depressive disorder during child's life
* Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)

Exclusion Criteria

* adolescent or parent ever diagnosed with bipolar I or schizophrenia;
* adolescent has a current DSM-IV mood disorder diagnosis

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Judith Garber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judy Garber, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard University Medical School

Boston, Massachusetts, United States

Site Status

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24. doi: 10.1001/jama.2009.788.

Reference Type RESULT

PMID: 19491183 (View on PubMed)

Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.

Reference Type RESULT

PMID: 24005242 (View on PubMed)

Brent DA, Brunwasser SM, Hollon SD, Weersing VR, Clarke GN, Dickerson JF, Beardslee WR, Gladstone TR, Porta G, Lynch FL, Iyengar S, Garber J. Effect of a Cognitive-Behavioral Prevention Program on Depression 6 Years After Implementation Among At-Risk Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Nov;72(11):1110-8. doi: 10.1001/jamapsychiatry.2015.1559.

Reference Type RESULT

PMID: 26421861 (View on PubMed)

Lynch FL, Dickerson JF, Clarke GN, Beardslee WR, Weersing VR, Gladstone TRG, Porta G, Brent DA, Mark TL, DeBar LL, Hollon SD, Garber J. Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up. Psychiatr Serv. 2019 Apr 1;70(4):279-286. doi: 10.1176/appi.ps.201800144. Epub 2019 Jan 3.

Reference Type DERIVED

PMID: 30929618 (View on PubMed)

Weersing VR, Shamseddeen W, Garber J, Hollon SD, Clarke GN, Beardslee WR, Gladstone TR, Lynch FL, Porta G, Iyengar S, Brent DA. Prevention of Depression in At-Risk Adolescents: Predictors and Moderators of Acute Effects. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):219-26. doi: 10.1016/j.jaac.2015.12.015. Epub 2016 Jan 18.

Reference Type DERIVED

PMID: 26903255 (View on PubMed)