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

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Bipolar disorder (BD) in youth is associated with significant impairments in functioning, treatment-resistance, and high public health costs. Recent research on prodromal forms of BD have identified symptomatic risk factors which increase the chances that genetically predisposed children will develop BD I or II disorder. The long-term goal of our research is to reduce the likelihood of or delay the full expression of BD among at-risk youth. The aim of this first phase (R34) is to develop and test a manual-based early psychoeducational intervention - family-focused treatment (FFT) - to determine if a large-scale early intervention trial with longer follow-up is warranted. FFT, consisting of psychoeducation, communication enhancement training, and problem-solving skills training, has been found to be effective in combination with pharmacotherapy in preventing recurrences and stabilizing the symptoms of adults and adolescents with BD. The present study consists of two phases and will be conducted at two sites: the University of Colorado (primary applicant site; D. Miklowitz, PI) and Stanford University (secondary site; K. Chang, Co-PI). In Phase I, we will identify 12 children aged 9-17 with putative prodromal BD who meet study criteria for high risk (i.e., have a first-degree relative with bipolar I or II disorder and meet criteria for BD not otherwise specified, cyclothymia, or major depressive disorder with hypomanic symptoms). In phase I, we will develop a manual for a 4-month, 12-session version of FFT for children at risk for BD, test therapist fidelity scales, and revise the manual in an iterative fashion in response to clinician and consumer feedback. We will examine consumer acceptance of the intervention and pre/post changes in the symptoms and functioning of the at-risk children (depression and mania scores, psychiatric status on the Adolescent Longitudinal Interval Follow-up) over a 1-year period. In phase II, we will randomly assign 40 high-risk children to either the newly manualized FFT or a treatment-as-usual (TAU) comparison. All children who require pharmacotherapy will receive it from study psychiatrists following best- practice guidelines. Participants in phase II will be examined over one year to test the hypothesis that FFT is more effective than TAU in reducing the severity of manic and depressive symptoms, increasing the amount of time spent well, delaying the onset of first manic, mixed or hypomanic episodes, improving functioning, decreasing distress among parents, and increasing the child's access to appropriate mental health services. The data analytic plan emphasizes mixed effects regression and survival analytic models. With 40 participants, phase II is well-powered to detect large and medium effect sizes assuming expected rates of attrition. The pilot trial will produce a finalized treatment manual that should be exportable to other treatment sites. It will yield estimates of population variability in targeted outcomes as a function of treatments, which should inform the development of a larger-scale early intervention trial. Principal Investigator/Program Director: Miklowitz, David J.