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）：本申请解决广泛挑战领域 4（临床研究）和具体挑战主题 04-MH-105（制定向成年过渡的干预措施和服务提供模型）。我们研究的目标是进行一项四中心（加州大学洛杉矶分校、埃默里大学、北卡罗来纳州、耶鲁大学）试点随机试验（N = 96），以确定 6 个月的以家庭为中心的治疗 (FFT) 与常规治疗 (TAU) 相比，对于符合治疗标准的 12-25 岁青少年，在增强功能结果、稳定症状以及预防或延缓完全精神病发作方面的功效。 根据前驱综合症结构化访谈 (SIPS)，出现前驱风险综合症。我们的第一、第二和第三假设分别是，在 6 个月和 12 个月的随访中，高危先证者对 FFT 的反应比 TAU 更好，具体体现在 (1) 学校和社会功能、家庭功能和父母痛苦、(2) 症状轨迹（SIPS 评分）和 (3) 首次完全精神病发作的时间方面。受试者将从目前资助的一项前瞻性纵向研究的参与者中抽取，该研究阐明了精神病转化的预测因素和机制（北美前驱症状纵向研究，简称 NAPLS），该研究由四个中心合作开展。受试者将在 2 年内每 6 个月接受一次访谈，以评估阳性和阴性症状、学业和社会功能、家庭功能以及向精神病的转变。我们提案的一个主要优点是招募和临床评估的费用将由 NAPLS 拨款承担，这使得挑战拨款的资源能够集中用于执行拟议的治疗研究。风险确定方法的最新进展使得能够可靠地识别患有前驱症状或“临床高风险”综合征的人，其中 35% 在 2 又 1/2 年内出现精神病。这种范式为在完全精神病发作和严重功能障碍积累之前的前驱阶段提供了开发和测试干预措施的机会。心理社会干预似乎非常适合解决精神病前驱症状中的动机缺陷和功能障碍问题。鉴于我们目前对精神病发病机制的了解，并且考虑到前驱患者抗精神病药物的初步研究在预防方面产生了令人沮丧的结果，减少功能障碍可能是短期内比减少精神病发病率更容易实现的目标。我们开发并试点了针对前驱青少年的 FFT 版本（FFT-PY），包括心理教育、沟通培训和解决问题技能培训。在随机试验中，与处于短暂心理教育控制条件下的患者相比，患有双相情感障碍的成人和青少年以及有双相情感障碍风险的儿童接受 FFT 后，症状和功能均得到改善。此外，针对有精神病风险的青少年进行的家庭心理教育的公开试验表明，相对于基线分数，症状和功能有所改善。然而，尚无随机对照研究检验 FFT 在减少功能障碍和预防功能恶化或完全精神病发作方面的功效。鉴于心血管疾病、糖尿病和某些癌症的预防方法提高了生活质量并降低了护理成本，精神病学领域需要大力致力于为其最令人衰弱的综合症（精神障碍）建立早期检测/预防框架。前驱风险综合征标准已经产生了在预测完全精神病发作方面非常有效的临床算法。然而，如果我们缺乏在发病前阶段进行干预的手段，以降低发展为完全精神病、功能障碍累积或两者兼而有之的可能性，那么这些知识的作用将是有限的。目前还没有经济有效、循证的心理社会方法来预防精神病。在这些疾病变成慢性之前预防早期发作的神经毒性作用，并最大限度地减少早期发作的社会心理后遗症，可能有助于预防精神病引起的长期残疾，从而对公众健康产生重大影响。我们的研究将迈出关键的下一步，对一项非常有前途的以家庭为中心的干预措施进行初步功效测试，该干预措施旨在稳定高危青少年的症状并改善其社会和角色功能。 公共卫生相关性：预防精神分裂症等精神疾病和相关功能障碍可以减轻个人和家庭痛苦以及社会经济损失的巨大负担。这个4中心项目旨在进行一项试点随机试验，以确定以家庭为中心的治疗与常规治疗相比在增强功能结果、稳定症状以及预防或延迟有前驱症状的过渡年龄青少年的完全精神病发作方面的功效。这项研究的结果对于开发具有成本效益、基于证据的心理社会方法来预防精神病至关重要，因此将对公共卫生产生重大影响。