A Randomized Clinical Trial Of Culturally Tailored MI

针对文化定制的 MI 的随机临床试验

• 批准号: 8776241
• 负责人: CHRISTINA S LEE
• 金额: $ 58.39万
• 依托单位: NORTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-12-15 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8776241
• 关键词: Acculturation; Address; Adopted; Adverse effects; Affect; Alcohol consumption; Alcoholic beverage heavy drinker; Alcohols; Area; Behavior; Caring; Cells; Cirrhosis; Clinical; Clinical Trials; Communities; Complex; Data; Dependence; Disadvantaged; Discrimination; Early Intervention; Ensure; Epidemiology; Equilibrium; Ethnic group; Evidence based treatment; Funding; Goals; Health; Health Services Research; Health behavior; Heavy Drinking; Immigrant; Informed Consent; Injury; Intervention; K-Series Research Career Programs; Knowledge; Language; Latino; Legal; Life; Mainstreaming; Minority; Modeling; Modification; Participant; Pattern; Pilot Projects; Population; Poverty; Process; Public Health; Randomized; Randomized Clinical Trials; Recovery; Recruitment Activity; Reporting; Research; Research Design; Research Personnel; Resources; Risk; Role; Services; Severities; Sexually Transmitted Diseases; Social Network; Source; Stress; Testing; Time; Translating; Treatment Efficacy; Treatment outcome; United States; United States National Academy of Sciences; Vehicle crash; Violent injury; Woman; Workplace; addiction; alcohol abuse therapy; alcohol related problem; alcohol risk; alcohol use disorder; base; behavioral outcome; behavioral response; burden of illness; comparative efficacy; cultural values; density of AOD outlets; drinking; drinking behavior; experience; follow-up; gender preference; hazardous drinking; health disparity; improved; individualized medicine; meetings; men; motivational enhancement therapy; motivational intervention; named group; prevent; programs; prospective; psychosocial; racial and ethnic; response; screening; screening and brief intervention; social; stressor; substance abuse treatment; treatment response; trial comparing

DESCRIPTION (provided by applicant): This application addresses the priority area Treatment for Health Disparities/Special Populations. Epidemiological and psychosocial research indicates that Latinos suffer greater adverse effects from hazardous drinking compared to other racial/ethnic groups, including higher rates of cirrhosis fatality and alcohol-involved motor vehicle crashes. Culturally-tailored empirically-based interventions are needed because Latinos suffer alcohol-related health disparities, are less likely to initiate and to remai in treatment, and are more likely to live in communities with high density of alcohol outlets. However, research on the field is challenged by the lack of studies comparing tailored to non-tailored treatments. We have pilot data from the PI's (New Investigator) K award (AA014905) demonstrating that culturally tailored motivational interviewing (CTMI) outperformed motivational interviewing (MI) that was not tailored to the needs of Latino heavy drinkers. This study will be the basis for the current proposed study, which is a larger scale version of the pilot. The key modification was to incorporate social stressors in the context of acculturation. Thus, in the proposed study, we will also explore acculturation stress as an influence on the relationship between acculturation and alcohol consumption behavior. The public health impact of this study will be to develop a program of early screening and brief intervention to reduce hazardous drinking among Latinos in communities that may lack such services. By providing early screening and intervention, we hope to minimize the burden of illness and social consequences that disproportionately affect Latino communities. Study Design: 357 Latino men and women who meet criteria for hazardous drinking (> 5/occasion for men, >4/occasion for women) will be recruited from the community. Following informed consent, they will complete a baseline assessment in either Spanish or English, and will then be randomized to receive either un-tailored motivational intervention (MI) or a culturally-tailored motivational intervention (CTMI). Participant randomization will be balanced by language preference, gender, alcohol severity, acculturation stress, and negative consequences, to ensure there is equivalent representation in each cell. Participants will be contacted by research assistants unaware of treatment assignment at 2, 6, and 12 months follow-up. Primary Aim 1: It is hypothesized that those randomized to receive the tailored treatment will report fewer alcohol- related negative consequences and fewer heavy drinking days at follow-up vs. those randomized to receive the un-tailored treatment. Primary Aim 2: Explore acculturation stress as a moderator of alcohol treatment outcomes. Long term goals: Develop a model of care that is easily disseminated in the community, and to generate theoretically-informed hypotheses to better understand how acculturation stress and processes confer risk for increased drinking among Latinos. We expect that this project will contribute needed knowledge about the role of acculturation stress in alcohol drinking behavior and treatment response.

描述（由申请人提供）：此申请涉及健康差异/特殊人群治疗的优先领域。流行病学和社会心理研究表明，与其他种族/族裔群体相比，拉丁美洲人因危险饮酒而遭受的不利影响更大，包括肝硬化死亡率和与酒精有关的机动车碰撞率更高。需要根据文化量身定制的基于经验的干预措施，因为拉丁美洲人遭受与酒精有关的健康差异，不太可能开始并继续接受治疗，并且更有可能生活在酒精销售点密集的社区。然而，由于缺乏对定制治疗和非定制治疗进行比较的研究，该领域的研究受到了挑战。我们有来自PI（新研究者）K奖（AA014905）的试点数据表明，文化定制的动机访谈（CTMI）优于非针对拉丁裔重度饮酒者需求定制的动机访谈（MI）。这项研究将是目前拟议研究的基础，这是一个更大规模的试点版本。关键的修改是将社会压力因素纳入文化适应的背景下。因此，在本研究中，我们还将探讨文化适应压力对文化适应与酒精消费行为之间关系的影响。这项研究的公共卫生影响将是制定一个早期筛查和简短干预计划，以减少可能缺乏此类服务的社区中拉丁裔人的危险饮酒。通过提供早期筛查和干预，我们希望将疾病负担和社会后果降到最低，这些疾病和社会后果对拉丁裔社区的影响尤为严重。研究设计：将从社区中招募357名符合危险饮酒标准的拉丁裔男性和女性（男性50岁/次，女性41岁/次）。在知情同意后，他们将用西班牙语或英语完成基线评估，然后随机接受非量身定制的动机干预（MI）或文化量身定制的动机干预（CTMI）。参与者的随机分配将根据语言偏好、性别、酒精严重程度、文化适应压力和负面后果进行平衡，以确保每个细胞中有相同的代表。在随访2个月、6个月和12个月时，研究助理将在不知道治疗分配的情况下与参与者联系。主要目的1：假设随机接受量身定制治疗的患者与随机接受非量身定制治疗的患者相比，在随访中报告的酒精相关负面后果和重度饮酒天数较少。主要目的2：探索文化适应压力对酒精治疗结果的调节作用。长期目标：发展一种易于在社区传播的护理模式，并产生有理论依据的假设，以更好地理解文化适应压力和过程如何赋予拉丁美洲人饮酒增加的风险。我们期望这个项目将有助于了解文化适应压力在饮酒行为和治疗反应中的作用。