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）：本申请涉及广泛挑战领域4（临床研究）和特定挑战主题04- MH-105（为成年过渡制定干预措施和服务提供模式）。我们的研究目标是进行一项四中心（UCLA, Emory, North Carolina, Yale）的随机试验（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）在增强功能结局，稳定症状以及预防或延迟根据前驱综合征（SIPS）符合前驱风险综合征标准的12-25岁青年的完全精神病发作方面的疗效。我们的主要、次要和第三假设分别是，在6个月和12个月的随访中，有风险的先证者对FFT的反应比TAU更好，在以下方面：(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）；(3)首次出现完全精神病的时间。受试者将从目前资助的前瞻性纵向研究（北美前驱期纵向研究，或NAPLS）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。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化。我们建议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可以集中在执行拟议的治疗研究上。最近在风险确定方法方面取得的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%的人在两年半内发展为精神病。这种模式为开发和测试前驱阶段的干预措施提供了机会，在完全精神病发作和大量功能残疾积累之前。心理社会干预似乎非常适合解决精神疾病前驱症状的动机缺陷和功能残疾问题。鉴于我们目前对精神病发病机制的了解，以及对前驱精神病患者的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，减少功能残疾可能是短期内比减少精神病发病率更容易实现的目标。我们已经开发并试点了一个针对前驱青少年的FFT （FFT- py）版本，包括心理教育、沟通培训和问题解决能力培训。在随机试验中，接受FFT治疗的成人和青少年双相情感障碍患者以及有双相情感障碍风险的儿童在症状和功能上都比在短暂心理教育控制条件下的患者有所改善。此外，一项对有精神病风险的青少年进行家庭心理教育的公开试验表明，相对于基线得分，症状和功能得到了改善。然而，没有随机对照研究检验FFT在减少功能残疾和预防功能恶化或完全精神病发作方面的功效。鉴于对心血管疾病、糖尿病和某些形式的癌症采取预防措施，提高了生活质量，降低了护理费用，精神病学领域需要作出重大承诺，对其最使人衰弱的综合症——精神病——建立早期发现/预防框架。前驱风险综合征的标准导致了临床算法，在预测完全精神病的发作是非常有效的。然而，如果我们缺乏在发病前阶段进行干预的手段，以减少发展为完全精神病的可能性，减少功能性残疾的积累，或两者兼而有之，那么这些知识的效用将是有限的。目前还没有成本效益高、循证的心理社会预防精神病的方法。在这些疾病变成慢性疾病之前，预防早期发作的神经毒性影响，并尽量减少早期发作的社会心理后遗症，可能会在很大程度上预防精神病造成的长期残疾，从而对公众健康产生重大影响。我们的研究将采取关键的下一步，对一个非常有前途的以家庭为中心的干预措施进行初步疗效测试，旨在稳定症状，改善有风险的青少年的社会和角色功能。