Designing and Testing a Family Therapy for Adolescent Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavioral Family Treatment
Community-based treatment as usual
Sponsored by

About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Options Counseling
- Oregon Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.
Participants will receive treatment as usual 1 year prior to the experimental treatment group.
Outcomes
Primary Outcome Measures
Center for Epidemiological Studies-Depression (CES-D) Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT00867919
First Posted
March 23, 2009
Last Updated
April 16, 2013
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00867919
Brief Title
Designing and Testing a Family Therapy for Adolescent Depression
Official Title
Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual 1 year prior to the experimental treatment group.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Family Treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Community-based treatment as usual
Intervention Description
Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies-Depression (CES-D) Scale
Time Frame
Measured pre- and post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa B. Sheeber, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Options Counseling
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Designing and Testing a Family Therapy for Adolescent Depression
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