Designing and Testing a Family Therapy for Adolescent Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00867919
First received: March 23, 2009
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Behavioral Family Treatment
Other: Community-based treatment as usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Center for Epidemiological Studies-Depression (CES-D) Scale [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: April 2009
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867919

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Options Counseling
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Lisa B. Sheeber, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00867919     History of Changes
Other Study ID Numbers: R34 MH076966, R34MH076966, DDTR B4-TBI
Study First Received: March 23, 2009
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014