NCT00867919

Brief Summary

This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Apr 2009

Typical duration for phase_1 depression

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

3.6 years

First QC Date

March 23, 2009

Last Update Submit

April 16, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Center for Epidemiological Studies-Depression (CES-D) Scale

    Measured pre- and post-intervention

Study Arms (2)

1

EXPERIMENTAL

Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.

Behavioral: Behavioral Family Treatment

2

ACTIVE COMPARATOR

Participants will receive treatment as usual 1 year prior to the experimental treatment group.

Other: Community-based treatment as usual

Interventions

11 to 15 sessions of a cognitive behavioral family therapy that will be developed during the course of this study and will address the following: * parent-adolescent conflict * adolescent development * support and closeness * behavioral activation * response to adolescent negative affect * relapse prevention * suicide prevention, if necessary

1

Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment

2

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Family with an adolescent between 14 and 18 years of age and at least one parent or permanent guardian with whom the adolescent resides
  • Family's primary concerns include depressive symptoms
  • Adolescent has a score above 24 on the Center for Epidemiological Studies-Depression Scale
  • Family will be seeking services at the community mental health center that is associated with the study

You may not qualify if:

  • Adolescents presenting with evidence of severe difficulties associated with comorbid conditions, such that the focus of treatment would need to shift to nonaffective symptoms
  • Adolescents evidencing symptoms of mania or psychoses or with suicidal behaviors requiring inpatient care
  • Adolescents with cognitive limitations of severity that will preclude meaningful participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Options Counseling

Eugene, Oregon, 97403, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Lisa B. Sheeber, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations