Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the effectiveness of family-focused psychoeducational treatment
      along with medication in treating adolescents with bipolar I disorder.
    

Detailed description: 
      Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes
      dramatic changes in a person's mood and energy. People with bipolar disorder undergo periods
      of extreme happiness and extreme sadness, known as episodes of mania and depression. Early
      onset of bipolar disorder poses an especially high health risk to affected individuals. For
      example, adolescents with bipolar I disorder are at increased risk for hospitalizations,
      social and academic deterioration, suicide, substance abuse, and nonadherence to medications.
      Treatment-based research for bipolar adolescents has lagged behind research for adults,
      particularly in the psychosocial arena. Family-focused treatment (FFT), consisting of
      psychoeducation about bipolar disorder for the patient and relatives, communication
      enhancement training, and problem-solving training, has shown promise as an effective
      psychosocial model. In two previous studies, FFT was found to be a useful addition to bipolar
      medications in treating adult bipolar I disorder. This study will test the effectiveness of
      FFT that is centered upon the developmental needs of adolescents with bipolar I disorder.

      This study will be divided into three phases. In Phases I and II, adolescent participants and
      their parents will be enrolled into FFT sessions; the adolescents will also be treated with
      medications using a clinical management manual. The first two phases will be used to revise
      and perfect the FFT adolescent (FFT-A) focused manual to be used in the Phase III clinical
      trial portion of the study.

      Participation in Phase III will last about 2 years. All adolescent and parent participants in
      Phase III will first undergo research interviews. Child-only interviews will last 2 hours and
      will include questions about mood problems, problems with friends or family members, and
      substance use history. Parent-only interviews will be conducted in two 1-hour sessions and
      will include questions about their child's mood and behavioral problems, treatments, and how
      their child's problems have affected family life. Parent participants will also be asked to
      assist their child in filling out a questionnaire on mood and behavioral problems and to fill
      out a questionnaire concerning their own history of problems with mood or anxiety. The last
      of the initial research interviews will be conducted at the University of Colorado's
      Psychology Department. Parent and child participants, as well as other relatives, will be
      asked to talk about problems in family life and ways to solve them. Participants will also be
      asked to describe pictures from inkblot cards.

      Next, participants in Phase III will be divided into 1 of 2 treatment groups: FFT-A plus
      standard bipolar medication or treatment as usual (TAU) plus standard bipolar medication.
      There will be a total of 25 FFT sessions over a 2-year period. The sessions will occur weekly
      for 12 weeks, every other week for the next 12 weeks, every month for 3 more months, and
      every 3 months for 1 more year. During FFT sessions, parent and adolescent participants will
      learn about mood disorders and ways to solve family problems. The sessions will be held at
      the Denver Children's Hospital, the University of Colorado Health Sciences Center's
      outpatient offices, or the University of Colorado's Psychology Department. Participants
      receiving TAU will be given an educational workbook on mood disorders and ways to cope with
      them as a family. TAU participants will attend three 3-hour family counseling sessions to
      explain the content of the workbook. The sessions will take place at the same locations as
      the FFT sessions. Child participants in both groups will take their prescribed medications
      for their bipolar disorder and will continue to see their psychiatrists on a regular basis.

      Repeat research interviews will occur every 3 months during the first year of the study and
      every 6 months during the second year of the study. Questionnaires will be distributed for
      children and their parents every 6 weeks during the first year of the study and every 3
      months during the second year of the study. A questionnaire on the child's functioning in the
      school setting will also be sent to the child participant's school teacher every 3 months.
      Outcome assessments will be made at baseline and Months 3, 6, 9, and 12.
    

Intervention name(s): Family-focused therapy for adolescents; Enhanced care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.; Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
Other intervention name(s): FFT-A; Treatment as usual (TAU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Family Treatment; Pharmacotherapy