Family-Focused Treatment for Bipolar Adolescents

描述（由申请人提供）：即使使用情绪稳定剂和抗精神病药物积极治疗，双相情感障碍（BP）青少年的复发率、自杀企图、功能损害和服务利用率也很高。尽管其相当大的公共卫生风险，有没有以精神病学为基础的，特定于障碍的心理干预与BP青少年。这项为期5年的研究将测试一种有前途的新干预措施对BP青少年的疗效，家庭为中心的治疗（FFT），作为一项3个地点的随机试验（U。科罗拉多的D. Miklowitz，PI]，U.匹兹堡[D. Axelson，PI]和Cinn。儿童[R. Kowatch，PI]）。在科罗拉多和匹兹堡的一项为期1年的治疗开发研究中，FFT是一项为期9个月的干预措施，包括心理教育、沟通训练和解决问题，导致青少年临床症状显著改善。我们将150例近期急性情感发作的BP I或BP II青少年（50例/研究中心）随机分为：（1）FFT加药物治疗或（2）简短的心理教育（增强护理或EC）加药物治疗。随机化将根据临床试验机构、双相I型和疾病极性进行分层。药物治疗将遵循由药物治疗委员会密切监测的一套最佳实践指南。结果评估包括K-SADS和纵向间隔随访评估，每3-6个月对父母和青少年进行一次，为期2年。生存和混合效应回归模型将测试的假设，FFT和药物治疗加速恢复，延迟复发，减少躁狂和抑郁症状，提高功能和生活质量，并减少辅助服务的使用相比，EC和药物治疗。次要分析将检验两个关于治疗调节因子（家族表达的情绪、基线症状严重程度）的假设和两个中介假设：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/觉醒规律性的改善预测躁狂症状的稳定。最后，我们将比较治疗的相对成本。在这项研究完成后，我们将获得一个知识库，以帮助开发一个最佳实践模式的治疗BP青少年，整合家庭为中心的问题解决与精神药理学。

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.