NCT00374439

Brief Summary

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an interpersonal therapy program for preventing depressive symptoms in adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

September 8, 2006

Last Update Submit

April 7, 2017

Conditions

Depressive Symptoms

Keywords

depressionadolescentspreventionschools

Outcome Measures

Primary Outcomes (2)

  • Children's Depression Inventory

    Change in depressive symptoms from baseline to post-intervention at 9 weeks

    9 weeks

  • Center for Epidemiological Studies - Depression scale

    Change in depressive symptoms from baseline to post-intervention at 9 weeks

    9 weeks

Study Arms (3)

Cognitive-behavioral

EXPERIMENTAL

Participants in this arm received a cognitive-behavioral program

Behavioral: Cognitive-behavioral

Interpersonal Therapy

EXPERIMENTAL

Participants in this arm received a prevention program based on interpersonal therapy for depression

Behavioral: Interpersonal Therapy

No intervention

NO INTERVENTION

Participants in this arm did not receive an intervention, but complete assessments only

Interventions

Cognitive-behavioralBEHAVIORAL

Cognitive-behavioral approach

Cognitive-behavioral
Interpersonal TherapyBEHAVIORAL

Interpersonal therapy approach

Interpersonal Therapy

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All students in 9th grade Wellness classes who have parental consent

You may not qualify if:

  • Students without parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203-5721, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Judy Garber, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Study Completion

April 1, 2006

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

US(1)