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Clinical Trials/NCT00867919
NCT00867919CompletedPhase 1

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

Oregon Research Institute2 sites in 1 country56 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
Center for Epidemiological Studies-Depression (CES-D) Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

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

Intervention: Behavioral Family Treatment (Behavioral)

2

Active Comparator

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

Intervention: Community-based treatment as usual (Other)

Outcomes

Primary Outcomes

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

Time Frame: Measured pre- and post-intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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