Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis

对有精神病风险的青少年进行以家庭为中心的治疗的预防试验

• 批准号: 7941766
• 负责人: TYRONE D CANNON
• 金额: $ 47.04万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7941766
• 关键词: Address; Adolescent; Adult; Adverse effects; Age; Algorithms; American; Antidepressive Agents; Antipsychotic Agents; Area; Bipolar Disorder; Cardiovascular Diseases; Caring; Case Management; Child; Chronic; Clinical; Clinical Research; Communication; Deterioration; Development; Diabetes Mellitus; Diagnostic; Distress; Early Diagnosis; Early intervention trials; Economics; Educational workshop; Family; Feedback; Funding; Goals; Grant; Incidence; Individual; Intervention; Interview; Knowledge; Longitudinal Studies; Malignant Neoplasms; Manuals; Metabolic; Methodology; Modeling; North Carolina; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Prevalence; Prevention; Preventive; Problem Solving; Procedures; Psychiatry; Psychotic Disorders; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Relative (related person); Research; Resources; Risk; Role; Schizophrenia; Schools; Services; Severities; Site; Social Functioning; Societies; Structure; Supervision; Symptoms; Syndrome; Testing; Time; Training; Work; Youth; active method; aged; base; cost; cost effective; disability; efficacy testing; evidence base; follow up assessment; follow-up; functional disability; functional improvement; functional outcomes; high risk; improved; meetings; neurotoxic; non-compliance; prevent; proband; prospective; psychoeducation; psychoeducational; psychosocial; public health relevance; randomized trial; research clinical testing; service intervention; skills training; stress management; symposium; therapy design; treatment as usual

DESCRIPTION (provided by applicant): This application addresses Broad Challenge Area 4 (Clinical Research) and Specific Challenge Topic 04- MH-105 (Developing interventions and service delivery models for the transition to adulthood). The goal of our research is to conduct a four-site (UCLA, Emory, North Carolina, Yale) pilot randomized trial (N = 96), to determine the efficacy of a 6-month Family-Focused Treatment (FFT) in comparison with Treatment-As-Usual (TAU) in enhancing functional outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in youth aged 12-25 years who meet criteria for a prodromal risk syndrome according to the Structured Interview for Prodromal Syndromes (SIPS). Our primary, secondary, and tertiary hypotheses, respectively, are that at-risk probands will respond better to FFT than TAU at 6- and 12-month follow-ups, in terms of (1) school and social functioning, family functioning, and parental distress, (2) symptom trajectories (SIPS scores), and (3) time to first onset of full psychosis. Subjects will be drawn from the participants in a currently funded prospective, longitudinal study elucidating predictors and mechanisms of conversion to psychosis (North American Prodrome Longitudinal Study, or NAPLS), on which the four sites collaborate. Subjects will be interviewed every 6 months for 2 years to assess positive and negative symptoms, academic and social functioning, family functioning, and conversion to psychosis. A major advantage of our proposal is that the costs of recruitment and clinical evaluation will be borne by the NAPLS grant, which allows the resources of the Challenge Grant to be concentrated on performing the proposed Treatment Study. Recent progress in risk ascertainment methodology has enabled reliable identification of persons with prodromal or "clinical high-risk" syndromes, 35% of whom develop psychosis within 2 and 1/2 years. This paradigm provides an opportunity for developing and testing interventions in the prodromal phase, before the onset of full psychosis and accumulation of substantial functional disability. Psychosocial interventions appear to be well suited to address issues of motivational deficits and functional disability in the psychosis prodrome. Given our present state of knowledge regarding the mechanisms of psychosis onset, and given that initial studies of antipsychotic drugs in prodromal patients have produced discouraging results in terms of prevention, a reduction in functional disability may represent a more achievable target in the short term than a reduction in psychosis incidence. We have developed and piloted a version of FFT for prodromal youth (FFT-PY) consisting of psychoeducation, communication training, and problem-solving skills training. In randomized trials, adults and adolescents with bipolar disorder and children at-risk for bipolar disorder undergoing FFT improved symptomatically and functionally compared to patients in brief psychoeducational control conditions. Further, an open trial of family psychoeducation for youth at risk for psychosis demonstrated symptomatic and functional improvements relative to baseline scores. However, no randomized controlled study has examined the efficacy of FFT for reducing functional disability and preventing functional deterioration or onset of full psychosis. In view of the improvements in quality of life and the reductions in costs of care that have occurred with preventive approaches to cardiovascular disease, diabetes, and certain forms of cancer, the field of psychiatry is in need of a major commitment to an early detection/prevention framework for its most debilitating syndromes - the psychotic disorders. The prodromal risk syndrome criteria have resulted in clinical algorithms that are highly effective in predicting onset of full psychosis. However, such knowledge will be of limited utility if we lack the means of intervening in the pre-onset phase in a way that either reduces the likelihood of progression to full psychosis, the accumulation of functional disability, or both. There are currently no cost- effective, evidence-based psychosocial approaches to psychosis prevention. Preventing the neurotoxic effects of early episodes, before these illnesses become chronic, and minimizing the psychosocial sequelae of early episodes, may do much to prevent the long-term disability caused by psychosis and thereby have a major impact on public health. Our study will take the critical next step by performing an initial efficacy test of a highly promising family-focused intervention designed to stabilize symptoms and improve social and role functioning in at risk youth. PUBLIC HEALTH RELEVANCE: Preventing psychotic disorders such as schizophrenia and associated functional disability could relieve an enormous burden of personal and family suffering and economic losses to society. This 4-site project aims to conduct a pilot randomized trial to determine the efficacy of a family-focused treatment in comparison with treatment-as-usual in enhancing functional outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in transitional age youth with prodromal symptoms. The results of this study will be crucial for the development of cost-effective, evidence-based psychosocial approaches to psychosis prevention and thus will have major implications for public health.

描述（由申请人提供）：此申请介绍了广泛的挑战区域4（临床研究）和特定挑战主题04- MH-105（开发过过渡到成年的干预措施和服务交付模型）。我们研究的目的是进行四个站点（UCLA，埃默里，北卡罗来纳州，耶鲁大学）随机试验（n = 96），以确定6个月以家庭为中心的治疗（FFT）的功效，而治疗效果（tau）与稳定的症状相比，并延迟了稳定的症状，并延迟了稳定的症状，并延迟了稳定的症状，并延迟了稳定的症状，并延迟了一项稳定的症状。前驱风险综合征根据前驱综合征（SIP）的结构化访谈。我们的主要，次要和第三级假设是，在（1）学校和社会功能，家庭功能和父母的遇险方面，处于6个月和12个月的随访中，处于危险的探险对FFT的反应比TAU的反应更好，（2）症状轨迹（SIPS得分），以及（3）首先发作完整的精神病。受试者将从参与者中汲取当前资助的前瞻性，纵向研究，阐明了转化为精神病的预测因素和机制（北美前驱纵向研究或NAPLS），这四个地点在其上合作。每6个月每6个月每6个月接受接受面试，以评估积极和负面症状，学术和社会功能，家庭功能以及转化为精神病。我们提案的一个主要优点是，NAPLS赠款将承担招聘和临床评估的成本，这使挑战赠款的资源可以集中于进行拟议的治疗研究。风险确定方法的最新进展使人们能够可靠地鉴定前往前序或“临床高风险”综合征的人，其中35％在2年和1/2年内发展精神病。该范式为在完全的精神病和实质性功能障碍的积累开始之前提供了一个在前驱阶段开发和测试干预措施的机会。社会心理干预似乎非常适合解决精神病前景中动机缺陷和功能障碍的问题。鉴于我们目前关于精神病发作机制的知识状态，并且鉴于对前驱患者的抗精神病药的初步研究在预防方面产生了令人沮丧的结果，因此在短期内，功能残疾的降低可能代表了比精神病发生率的降低的目标。我们已经开发并试行了由心理教育，沟通培训和解决问题的技能培训组成的前驱青年（FFT-PY）的FFT版本。在随机试验中，与短暂的心理教育对照条件下的患者相比，与患有FFT的躁郁症和儿童患有双相情感障碍的成年人和青少年在症状和功能上有所改善。此外，针对患有精神病风险的年轻人的家庭心理教育的开放试验相对于基线得分表现出症状和功能改善。但是，尚无随机对照研究检查FFT在减少功能障碍并防止功能降解或全部精神病发作的功效。鉴于生活质量的改善以及用于心血管疾病，糖尿病和某些形式的癌症的预防方法所发生的护理成本的降低，精神病学领域需要对早期发现/预防框架的主要承诺，以实现其最衰弱的衰弱综合症 - 精神病患者。前驱风险综合征标准已导致临床算法，这些算法非常有效地预测了全精神病的发作。但是，如果我们缺乏在预发阶段进行干预的手段，以降低发展为全精神病的可能性，功能障碍的积累或两者兼有的方式，那么这种知识将是有限的。目前没有具有成本效益的，基于证据的心理心理健康预防方法。在这些疾病变得慢性之前，可以防止早期发作的神经毒性作用，并最大程度地减少早期发作的心理后遗症，这可能对预防精神病引起的长期残疾有很大的作用，从而对公共卫生产生重大影响。我们的研究将通过对旨在稳定症状并改善AT风险青年的社交和角色功能的高度有希望的家庭干预措施进行初步疗效测试来迈出关键的下一步。 公共卫生相关性：预防精神分裂症和相关功能障碍等精神病患者可能会减轻个人和家庭苦难以及对社会的经济损失的巨大负担。这个四个站点的项目旨在进行一项试验随机试验，以确定以家庭治疗为中心的治疗的疗效，与惯常的治疗方法相比，在增强功能性结果，稳定症状并防止或延迟了具有前途症状的过渡时代青年中的全部精神病的发作。这项研究的结果对于开发具有成本效益的，基于证据的心理心理健康的心理心理方法的方法至关重要，因此将对公共卫生产生重大影响。