Family-Focused Treatment for Bipolar Adolescents

描述（由申请人提供）：患有双相情感障碍（BP）的青少年即使接受情绪稳定剂和抗精神病药物的积极治疗，也有很高的复发率、自杀未遂率、功能障碍率和服务利用率。尽管其具有相当大的公共健康风险，但对于患有BP的青少年，尚无基于经验的、针对特定障碍的心理社会干预措施。这项为期5年的研究将在一项3点随机试验中测试一种有希望的新干预措施对BP青少年的疗效，即以家庭为中心的治疗（FFT），作为仔细对照药物治疗的辅助手段。Axelson, PI]，和Cinn。儿童(R。Kowatch,π])。FFT是一项为期9个月的干预，包括心理教育、沟通训练和解决问题，在科罗拉多和匹兹堡进行的一项为期一年的治疗发展研究中，FFT在青少年中取得了显著的临床改善。我们将随机抽取150名最近有急性情感发作的BP I或BP II青少年（50人/个地点）分为：(1)FFT加药物治疗或(2)简短的心理教育（强化护理或EC）加药物治疗。随机化将根据现场、双相I型和疾病极性进行分层。药物治疗将遵循一套由药物治疗委员会密切监测的最佳实践指南。结果评估包括K-SADS和纵向间隔随访评估，在2年内每3-6个月对父母和青少年进行一次。与EC和药物治疗相比，生存和混合效应回归模型将检验FFT和药物治疗加速恢复、延迟复发、减少躁狂和抑郁症状、增强功能和生活质量、减少辅助服务利用的假设。二级分析将检验两个关于治疗调节因子的假设（家族表达的情绪，基线症状严重程度）和两个中介假设：治疗相关的家庭功能改善预测抑郁症状的稳定，而药物依从性和睡眠/觉醒规律的改善预测躁狂症状的稳定。最后，我们将比较治疗的相对费用。在研究完成后，我们将获得一个知识库，以帮助开发一个治疗BP青少年的最佳实践模型，该模型将以家庭为中心的问题解决与精神药理学相结合。

DESCRIPTION (provided by applicant): 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.