Early Intervention for Youth at Risk for Bipolar Disorder
Condition: Bipolar Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      Children or teens with mood swings or depression who have a parent with bipolar disorder are
      at high risk for developing bipolar disorder themselves. This study will test a family-based
      therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk
      children (ages 9-17). In a randomized trial, the investigators will compare two kinds of
      family-based treatment (one more and one less intensive) on the course of early mood symptoms
      and social functioning among high-risk children followed for up to 4 years. The investigators
      will examine the effects of family treatment on measures of neural activation using
      functional magnetic resonance imaging.
    

Detailed description: 
      Children who are at high risk for developing bipolar disorder (BD) often are showing
      significant mood swings or depression well before they develop the full disorder. Often,
      these children have one or more parents who have bipolar disorder. In addition to brief
      episodes of lethargic depression and mania or hypomania (periods of excessive activity),
      children and adolescents at risk for 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 has been designed to help children and adolescents who are at risk for
      developing BD. FFT will combine education about BD with 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 reduce the early symptoms of BD, improve functioning, and delay the onset
      or reduce the severity of manic episodes.

      Participation in this study will last up to 4 years, although the majority of the study will
      occur in the first year. There are 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 provide information on the family
      background of mood or anxiety problems. All participants will receive a thorough
      medical-psychiatric evaluation and be provided with pharmacotherapy (as needed) from a study
      psychiatrist for the first year of the study.

      In the second part, participants will be randomly assigned to receive one of two treatments:
      FFT or enhanced care. 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
      enhanced care will have 3 weekly sessions which will involve the youth and all family
      members. In session 1, clinicians summarize the diagnostic assessment, introduce mood
      charting, and offer instructional handouts on managing mood swings. In session 2, clinicians
      revisit mood charting, discuss medications (if relevant), and help the child and family
      develop a mood management plan. In session 3, families rehearse mood regulation strategies
      for current family, social or academic problems. Clinicians then meet with the child
      individually every month for the next 3 mos. to provide support, assist with problem-solving,
      and troubleshoot use of the mood management plan. So, both treatments last 4 months.

      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.

      The statistical analyses for this study will examine changes in symptoms and functioning from
      the baseline assessment through the 4 month follow-ups in year 1 and the 6 month follow-ups
      in years 2-4.
    

Intervention name(s): Enhanced Care; Family-Focused Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 3 family sessions involve the youth and all family members. These sessions will help the child and family members with mood charting and developing a mood management plan. Families will rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan.; 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. The goal of this intervention is to improve the child's ability to regulate moods and to reduce tension and conflict in the family.
Other intervention name(s): Psychoeducation; Case Management; Family Therapy; Family Psychoeducation; FFT; Family Intervention; Psychoeducation; Family Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bipolar disorder; Major depressive disorder; Mania; Depression; Cyclothymic Disorder