Adolescents with bipolar disorder (BP) have high rates of recurrence, suicide attempts, functional impairment, and service utilization even when aggressively treated with mood stabilizers and antipsychotics. Despite its considerable public health risk, there are no empirically-based, disorder-specific psychosocial interventions for adolescents with BP. This 5-year study will test the efficacy of a promising new intervention for BP adolescents, family-focused treatment (FFT), as adjunct to carefully controlled pharmacotherapy in a 3-site randomized trial (U. of Colorado [coordinating site;D. Miklowitz, PI], U. of Pittsburgh [D. Axelson, PI], and Cinn. Childrens [R. Kowatch, PI]). FFT, a 9-month intervention consisting of psychoeducation, communication training, and problem-solving, led to significant clinical improvements among adolescents in a 1-year treatment development study at Colorado and Pittsburgh. We will randomize 150 BP I or BP II adolescents (50/site) with a recent acute affective episode to: (1) FFT plus pharmacotherapy or (2) brief psychoeducation (enhanced care, or EC) plus pharmacotherapy. Randomization will stratify on site, bipolar I, and illness polarity. Pharmacotherapy will follow a set of best practice guidelines as closely monitored by a pharmacotherapy committee. Outcome assessments include the K-SADS and the Longitudinal Interval Follow-up Evaluation given to parents and adolescents every 3-6 months over 2 years. Survival and mixed effects regression models will test the hypotheses that FFT and pharmacotherapy hasten recovery, delay recurrences, reduce manic and depressive symptoms, enhance functioning and quality of life, and reduce ancillary service utilization when compared to EC and pharmacotherapy. Secondary analyses will test two hypotheses concerning treatment moderators (familial expressed emotion, baseline symptom severity) and two mediational hypotheses: treatment-associated improvements in family functioning predict the stabilization of depressive symptoms, whereas improvements in medication adherence and sleep/wake regularity predict the stabilization of manic symptoms. Finally, we will compare the relative costs of treatments. At the study's completion, we will have obtained a knowledge base to help develop a best practice model of treatment for BP adolescents that integrates family-focused problem-solving with psychopharmacology.
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