Designing and Testing a Family Therapy for Adolescent Depression
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|ClinicalTrials.gov Identifier: NCT00867919|
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : April 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Behavioral Family Treatment Other: Community-based treatment as usual||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1|
|Study Start Date :||April 2009|
|Primary Completion Date :||November 2012|
|Study Completion Date :||December 2012|
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:
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
- Center for Epidemiological Studies-Depression (CES-D) Scale [ Time Frame: Measured pre- and post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867919
|United States, Oregon|
|Eugene, Oregon, United States, 97403|
|Oregon Research Institute|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Lisa B. Sheeber, PhD||Oregon Research Institute|