Early Intervention for Youth at Risk for Bipolar Disorder

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.

Inclusion Criteria:

- For a child to be eligible:

- At least one biological parent or stepparent with whom the child or adolescent
lives must be willing to participate in family treatment

- At least one biological parent has a verifiable diagnosis of bipolar disorder I
or II

- The child must have a DSM-IV diagnosis of bipolar disorder not otherwise
specified or major depressive disorder (MDD)

- If the main diagnosis is MDD, the depressive episode must have occurred within
the past 2 years

- The child must have evidence of current significant affective symptoms, as
determined by a score greater than 11 on the Young Mania Rating Scale within the
last week or a score greater than 29 on the Child Depression Rating
Scale-Revised within the last 2 weeks

- The family must speak English, although English need not be their first language

Exclusion Criteria:

- Fully diagnosable bipolar disorder I or II

- Diagnosis of autism or pervasive developmental disorder

- Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than
70

- Presence of comorbid neurologic diseases such as seizure disorder

- Substance or alcohol abuse or dependence disorders in the 4 months prior to study
recruitment

- Evidence of a life-threatening eating disorder or other medical disorder that
requires emergency medical treatment

- Currently enrolled in regular family therapy

- Evidence of current sexual or physical abuse or domestic abuse between the adult
partners