NCT00904891

Brief Summary

This study will test the effectiveness of two programs for preventing depression in adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for phase_2 depression

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2 depression

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, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

4.4 years

First QC Date

May 19, 2009

Last Update Submit

March 10, 2014

Conditions

Depression

Keywords

AdolescentsPreventionBibliotherapy

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms obtained from Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months

Secondary Outcomes (1)

  • Score on Beck Depression Inventory (BDI)

    Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months

Study Arms (3)

1

EXPERIMENTAL

Participants will receive a cognitive-behavioral group intervention.

Behavioral: Cognitive-behavioral group

2

ACTIVE COMPARATOR

Participants will receive cognitive-behavioral bibliotherapy.

Behavioral: Cognitive-behavioral bibliotherapy

3

NO INTERVENTION

Participants will only complete study assessments.

Interventions

Cognitive-behavioral groupBEHAVIORAL

Six sessions of cognitive-behavioral depression prevention group intervention

1
Cognitive-behavioral bibliotherapyBEHAVIORAL

Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"

2

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school student
  • Subthreshold depressive symptoms

You may not qualify if:

  • Meets criteria for major depression or dysthymia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Paul D. Rohde, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

US(1)