Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder

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.

Inclusion Criteria:

- Has at least one biological parent or stepparent with whom the child or adolescent
participant lives and who is willing to participate in family treatment

- Has a DSM-IV diagnosis of at least one of the following within the past 2 years :
bipolar disorder not otherwise specified (BD-NOS), major depressive disorder (MDD),
or cyclothymia

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

- Has 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

- Not currently enrolled in family or marital therapy

- Has at least one biological parent or sibling with a verifiable diagnosis of bipolar
disorder I or II

- Speaks English

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

- Has previously been treated with family-focused therapy

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