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Prevention of Depression in At-Risk Adolescents

Prevention of Depression in At-Risk Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00073671
Enrollment
316
Registered
2003-12-03
Start date
2003-03-31
Completion date
2009-01-31
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Adolescent

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALCognitive-behavioral prevention program

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

OTHERUsual care

Participants receive usual care

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor were unaware of condition assignment

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)Time to a score of 4 or higher between baseline and 9 months using survival analysisa score of 4 or greater is considered an onset

Secondary

MeasureTime frameDescription
Number of depression-free daysMeasured continuously through Month 33Using the depression symptom ratings (DSR) (1-6), each week is given a score of 1 to 6; depression-free days are those with ratings of 1 or 2 on the DSR.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026