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

以家庭为中心的治疗作为双相情感障碍风险青少年的早期治疗

• 批准号: 7391065
• 负责人: DAVID Jay MIKLOWITZ
• 金额: $ 21.01万
• 依托单位: UNIVERSITY OF COLORADO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7391065
• 关键词: Adolescent; Adult; Advocate; Age; Behavioral Symptoms; Bipolar Disorder; Child; Child Health Services; Colorado; Communication; Condition; Confidence Intervals; Consumer Satisfaction; Cyclothymic Disorder; DSM-IV; Data; Deterioration; Development; Diagnosis; Diagnostic; Disease; Disease regression; Disease remission; Distress; Early Intervention; Early intervention trials; Early treatment; Effectiveness; Emotional; Enrollment; Family; Family Relationship; Family history of; Family member; Feasibility Studies; Feedback; First Degree Relative; Goals; Health Care Costs; Impairment; Individual; Intervention; Intervention Studies; Lead; Life; Major Depressive Disorder; Manic; Manuals; Mental Health Services; Modeling; Mood stabilizers; Moods; Morbidity - disease rate; Not Otherwise Specified; Outcome; Parents; Participant; Patients; Personal Satisfaction; Pharmacotherapy; Phase; Population; Practice Guidelines; Principal Investigator; Problem Solving; Procedures; Process; Protocols documentation; Psychiatrist; Puberty; Public Health; Randomized; Randomized Controlled Clinical Trials; Rate; Recurrence; Relapse; Research; Resistance; Risk; Risk Factors; Schools; Score; Self Care; Severities; Siblings; Site; Social Functioning; Standards of Weights and Measures; Suicide; Symptoms; Testing; Time; Training; Universities; Week; Work; Youth; aged; base; child depression; child mental health service; coping; cost; depressive symptoms; disability; early /brief intervention /therapy; early onset; follow-up; functional outcomes; hypomania; improved; improved functioning; pilot trial; prevent; proband; programs; psychoeducation; psychoeducational intervention; psychosocial; response; size; skills; skills training; social; stressor; success; therapy development; treatment site

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.

青少年中的双相情感障碍(BD)与严重的功能障碍、治疗耐药性和高昂的公共卫生成本有关。最近对BD先兆形式的研究已经确定了症状危险因素，这些因素增加了遗传易感儿童发展为BD I或II障碍的机会。我们研究的长期目标是减少或推迟BD在高危青年中充分表达的可能性。第一阶段(R34)的目的是开发和测试基于手动的早期心理教育干预--以家庭为中心的治疗(FFT)--以确定是否有必要进行大规模的早期干预试验，并进行更长时间的随访。FFT包括心理教育、沟通增强训练和解决问题的技能训练，已被发现与药物治疗相结合在预防复发和稳定成人和青少年BD症状方面是有效的。本研究包括两个阶段，将在两个地点进行：科罗拉多大学(主要申请地点；D.Miklowitz，Pi)和斯坦福大学(次要地点，K.Chang，共同-PI)。在第一阶段，我们会找出12名年龄介乎9-17岁的先兆BD儿童，他们符合研究的高风险标准(即有I或II双相情感障碍的一级亲属，并符合BD的标准，而该等标准并无特别说明)、循环胸腺症或伴有低躁狂症状的严重抑郁障碍。在第一阶段，我们将为有BD风险的儿童开发一份为期4个月、12节的FFT版本的手册，测试治疗师的忠诚度量表，并根据临床医生和消费者的反馈以迭代的方式修订手册。我们将检查消费者对干预措施的接受程度，以及高危儿童症状和功能(抑郁和躁狂评分，青少年纵向间隔随访中的精神状态)在一年期间的前后变化。在第二阶段，我们将随机将40名高危儿童分配到新的手册FFT或照常治疗(TAU)比较中。所有需要药物治疗的儿童都将按照最佳实践指南从研究精神病学家那里获得药物治疗。第二阶段的参与者将接受一年多的检查，以测试FFT在以下方面比TAU更有效的假设：FFT在减轻躁狂和抑郁症状的严重性、增加良好花费的时间、推迟首次躁狂、混合或轻度躁狂发作、改善功能、减少父母的痛苦以及增加儿童获得适当心理健康服务的机会方面比TAU更有效。数据分析计划强调混合效应回归和生存分析模型。第二阶段有40名参与者，在假设预期的流失率的情况下，能够很好地检测大中型影响。试点试验将产生一份最终的治疗手册，应该可以出口到其他治疗地点。它将产生作为治疗功能的目标结果中的人群变异性的估计，这应该会为更大规模的早期干预试验的发展提供信息。首席调查员/项目主任：Miklowitz，David J.