Clinical trial NCT00867919: Designing and Testing a Family Therapy for Adolescent Depression
Official title: Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-24
Enrollment: 56
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Center for Epidemiological Studies-Depression (CES-D) Scale
timeFrame: Measured pre- and post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Options Counseling
state: Oregon
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Lisa B. Sheeber, PhD
role: PRINCIPAL_INVESTIGATOR
References: