Designing and Testing a Family Therapy for Adolescent Depression

April 16, 2013 updated by: Oregon Research Institute

Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adolescent depression causes persistent feelings of sadness, loss of self-worth, discouragement, and loss of interest in usual activities. Treatments for adolescent depression have mixed success, with 25% to 40% of depressed adolescents still experiencing depressive symptoms at the end of the most effective treatments and gains made in treatment sometimes fading over time. Research suggests that family processes are associated with the effectiveness of treatments for adolescent depression and with reducing symptoms over time. Evidence also shows that treatments developed and tested in a research setting are not easily applied to community settings. This study will first design a cognitive behavioral therapy for adolescent depression that will involve the families of the depressed adolescents and then test the therapy in several settings, including clinics.

Development of this therapy will involve five different groups of participants. Each group will include both depressed adolescents and a parent or guardian. The first group of participants will partake in a focus group, in which they will break into two discussion groups, one of parents and guardians and one of adolescents, that will discuss what kind of help and information would be useful to them and why they would consider seeing a therapist.

The second group will participate in alpha testing, which will involve receiving the first version of the therapy. The therapy is anticipated to include 8 to 12 weekly treatment sessions, with homework assignments to practice their learned skills in everyday life. Participants in alpha testing will also complete interviews and questionnaires at Week 7 and at the end of treatment to assess satisfaction with treatment, treatment clarity, and usefulness of the information and strategies they learned. After alpha testing, the therapy will be revised based on the feedback received. The third group will participate in beta testing, which will involve receiving the second version of the therapy and completing the same assessments as those done by the alpha group.

The fourth group of participants will receive pilot testing of the finalized therapy. This finalized version will involve 11 to 15 weekly sessions. The fifth group will receive treatment as usual from a mental health clinic and serve as a control group to compare to the pilot testing group. Before and after treatment, both of these groups will complete questionnaires and interviews assessing the effectiveness of their treatment and questionnaires and observations of family functioning. All sessions throughout the study involving the newly designed family therapy will be videotaped.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute
      • Eugene, Oregon, United States, 97403
        • Options Counseling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.
Behavioral: Behavioral Family Treatment

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
Active Comparator: 2
Participants will receive treatment as usual 1 year prior to the experimental treatment group.
Other: Community-based treatment as usual
Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiological Studies-Depression (CES-D) Scale
Time Frame: Measured pre- and post-intervention
Measured pre- and post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Lisa B. Sheeber, PhD, Oregon Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH076966 (U.S. NIH Grant/Contract)
  • DDTR B4-TBI (ClinicalTrials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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