Informed Consent for Latinos with Schizophrenia

描述(申请人提供)：拉美裔是美国最大的少数族裔群体，但在NIMH和FDA相关的精神健康研究中仍然远远没有得到充分的代表。对于一些拉丁裔来说，注册的最突出的障碍之一可能是知情同意过程中的语言障碍。重要的是要避免将拉美裔人刻板印象为单一的背景、偏好或技能；与知情同意程序有关的关键因素(如语言、文化适应、教育和健康素养)可能差异很大，但也往往在拉丁裔亚群中交织在一起。尽管在过去15年中已经积累了关于神经精神病学人群的决策能力和知情同意程序的宝贵经验数据，但在拉丁裔社区中，侧重于知情同意的这类研究一直很少。该项目将填补这一重要的经验信息缺口。具体目标包括确定语言、文化适应、教育、健康和研究素养对参与者的初始理解和1个月信息保留的影响程度。此外，基于强调研究模式在同意过程中的作用的概念模型，我们还将测试同意前教育干预(在讨论特定方案之前向参与者传授临床研究和同意过程)对初始理解和1个月保留的影响。参与者将包括180名精神分裂症或分裂情感障碍患者[60名西班牙语偏好的拉丁裔，60名英语偏好的拉丁裔，以及60名(讲英语的)非拉丁裔白人]。参与者将被随机分配到常规的或教育增强的同意程序中进行假设性的第三阶段临床试验。措施将包括文化适应、健康素养和对同意程序中披露的信息的理解程度的标准评分表。此外，将对30名参与者进行定性访谈，以确定他们对同意程序的印象，以及他们对知情同意和参与研究决策的偏好。所有程序、面谈和评估都将由双语双文化研究人员用每位参与者首选的语言(西班牙语或英语)进行。通过提供信息，促进有效的、在语言和文化上适当的同意程序，拟议的工作将有助于实现NIMH战略计划的目标3，即“开发新的更好的精神障碍干预措施，纳入精神疾病患者的不同需求和情况。”

DESCRIPTION (provided by applicant): Latinos are the largest ethnic minority group in the U.S., yet remain vastly underrepresented in NIMH and FDA-associated mental health research. One of the most salient barriers to enrollment for some Latinos may be language barriers in the informed consent process. It is important to avoid stereotyping Latinos as being characterized by a monolithic background, preferences, or skills; key factors likely relevant to the informed consent process (such as language, acculturation, education, and health literacy) vary widely, yet also tend to be intertwined among Latino subgroups. Although valuable empirical data on decisional capacity and the informed consent process in neuropsychiatric populations has amassed over the past 15 years, there has been a dearth of such research focused on informed consent in the Latino Community. This project will serve to fill this vital empirical information gap. Specific aims include identifying the degree to which language, acculturation, education, health, and research literacy affect participants' initial comprehension and 1-month retention of information. In addition, grounded in a conceptual model highlighting the role of a research schema in the consent process, we will also test the effects of a pre-consent educational intervention (teaching participants about clinical research and the consent process prior to discussing a specific protocol) on initial comprehension and 1-month retention. Participants will include 180 people with schizophrenia or schizoaffective disorder [60 Latinos with Spanish language preference, 60 Latinos with English preference, and 60 (English speaking) non-Latino whites]. Participants will be randomized to a routine or educationally enhanced consent procedure for a hypothetical phase 3 clinical trial. Measures will include standard rating scales of acculturation, health literacy, and comprehension of information disclosed during consent procedures. In addition, qualitative interviews will be conducted with a subsample of 30 participants to ascertain their impressions of the consent procedures, as well as their preferences regarding informed consent and decision making about research participation. All procedures, interviews, and assessments will be conducted in each participant's preferred language (Spanish or English) by bilingual- bicultural research staff. By providing information to foster effective and linguistically and culturally appropriate consent procedures, the work proposed will facilitate pursuit of Objective 3 in the NIMH Strategic Plan, i.e., to "Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness."