Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This study will test a family-based therapy aimed at preventing or reducing the symptoms of
      bipolar disorder in at-risk children.
    

Detailed description: 
      Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age 18.
      In addition to the debilitating effects of BD, which include episodes of lethargic depression
      and exhausting mania, children and adolescents with BD often have co-occurring disorders,
      such as attention deficit hyperactivity disorder, conduct disorder, substance abuse
      disorders, and anxiety disorders. Early interventions may lead to better mental health by
      preventing BD from ever fully expressing itself. This study will test an early intervention
      for BD called family-focused treatment (FFT), which targets children and adolescents who are
      at risk for developing BD. FFT will include education about BD and training in communication
      strategies and problem-solving skills. It will focus on the family, because family
      environmental factors are related to the course and recurrence of BD. By reducing risk
      factors and teaching coping skills, FFT aims to prevent expression of BD, delay the onset or
      reduce the severity of manic episodes, and ensure that the first treatment received is
      appropriate.

      Participation in this study will last 1 year and include three parts. In the first part,
      participating children and their families will complete research interviews and
      questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants
      will also provide information on the family background of mood or anxiety problems. In the
      second part, participants will be randomly assigned to receive one of two treatments: FFT or
      brief educational treatment. Participants receiving FFT will complete 12 therapy sessions in
      which parents, children, and siblings learn how to cope with mood disorders, new ways to talk
      to each other, and strategies for solving family problems. FFT sessions will occur weekly for
      the first 8 weeks and then every other week for the next 8 weeks. Participants receiving
      brief educational treatment will complete diagnostic assessments and a 1-hour individualized
      feedback session, and they will be given a workbook about childhood mood disorders. A
      counselor will be available to all participants, in case of emergencies, for the full study
      year. All participants will also be provided with standard pharmacotherapy as needed. In the
      third part of the study, participants will complete follow-up assessments every 4 months for
      1 year. Assessments will include interviews and questionnaires similar to those completed in
      the first part of the study.
    

Intervention name(s): Family-focused therapy; Brief educational treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. Ongoing medication management from a study psychiatrist will be available.; Thorough diagnostic assessment by a study evaluator, separate evaluation by a child psychiatrist, feedback session with parents and child, and provision of reading materials pertinent to managing childhood mood disorders. Ongoing medication management and crisis-oriented family sessions will be available as needed.
Other intervention name(s): FFT; Family Therapy; Psychoeducation; Psychosocial Intervention; Psychotherapy; Behavior Therapy; Psychoeducation; Crisis Management; Enhanced Care; Diagnostic Evaluation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Early Signs of Bipolar Disorder; High Risk Youth; Adolescence; Childhood