Preparing a computerized tool for preventing prenatal drinking for a larger trial

准备用于预防产前饮酒的计算机化工具以进行更大规模的试验

基本信息

批准号：
8918394
负责人：
Madhabika Nayak
金额：
$ 26.19万
依托单位：
PUBLIC HEALTH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-01 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8918394
关键词：
Address Affect Alcohol consumption Alcohols Applications Grants Behavior Therapy California Caring Child Clinic Congenital Abnormality Consumption Control Groups Data Development Disclosure Drug usage Electronics Experimental Designs Feedback Female of child bearing age Fetal Alcohol Spectrum Disorder Frequencies Fright Future Health Health Services Accessibility Health Services Research Healthcare Heavy Drinking Hispanics Individual Infant Intervention Intervention Studies Literature Manuals Maternal and Child Health Measures Mental Depression Modeling Outcome Outcome Measure Participant Patient Self-Report Pharmaceutical Preparations Pregnancy Pregnant Women Prevention Primary Prevention Procedures Public Health Randomized Randomized Clinical Trials Randomized Controlled Trials Reporting Research Research Project Grants Resources Risk Safety Sampling Self-Administered Specific qualifier value Staging Stigmatization Testing Therapeutic Studies Time Tobacco Treatment Efficacy United States Unplanned pregnancy Woman adverse outcome alcohol consumption during pregnancy alcohol intervention base bilingualism computerized computerized tools cost cost effective design disorder prevention drinking follow-up group intervention improved innovation intervention program multi-arm study novel phase II trial pregnant prenatal prevent primary outcome programs randomized trial screening and brief intervention secondary outcome sweetened beverage tool treatment as usual unintended pregnancy

项目摘要

DESCRIPTION (provided by applicant): This R34 grant application responds to PAR-12-279's call for new and adapted alcohol interventions. We focus on a national priority, the prevention of drinking during pregnancy and Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol use, a leading cause of preventable birth defects in the U.S., continues to be a public health problem. Delayed pregnancy recognition and stigmatization concerns related to disclosure of drinking hamper prevention efforts with pregnant women. Heavy drinking increases risk for unintended pregnancy and for prenatal drinking. Thus, high rates of heavy drinking and of unplanned pregnancies in women in the U.S. suggest the need for primary prevention with all women of childbearing age. Screening and brief intervention (SBI) reduces drinking but remains underutilized due to resource limitations in public health care. The impending implementation of the Affordable Care Act (ACA) in an economy with dwindling health care resources indicates an urgent need for low-cost tools for delivering SBI. We propose to study a recently piloted, self-administered, computerized tool for reducing prenatal drinking that adds novel components of drink size assessment and drink size feedback to traditional SBI. We will adapt this bilingual (English and Spanish) electronic SBI or "e-SBI" for use with non-pregnant women and conduct a small trial of its efficacy in a public health clinic. We will also study effects of drink size assessment by itself and if depression modifies e- SBI efficacy. Study findings will help design a larger trial of e-SBI's efficacy for reducing prenatal alcohol use. We will use an experimental design for the proposed small trial. We will randomly assign 150 women, who have not been pregnant in the past year and report drinking, to e-SBI or usual care. We will complete baseline, 3-month and 6-month follow-up assessments, and examine drinking and pregnancy as primary outcomes, and health risks, i.e., drug use, sweetened beverage and depression as secondary outcomes. Secondary outcome data allow us to examine e-SBI's potential negative effects and set our proposed study apart from prior e-SBI studies that did not examine possible SBI-related adverse outcomes, such as increased drug use. To address methodological limitations in prior research, we will incorporate drink size assessment to better measure drinking outcomes, minimize assessment reactivity for controls at baseline, and include a booster e-SBI at the 3-month follow up. This allows us to examine whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, ur study will provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohl use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.

描述（由申请人提供）：此 R34 拨款申请响应 PAR-12-279 对新的和适应性酒精干预措施的呼吁。我们关注国家优先事项，即预防怀孕期间饮酒和胎儿酒精谱系障碍 (FASD)。产前饮酒是美国可预防的出生缺陷的主要原因，仍然是一个公共卫生问题。与披露孕妇饮酒礼篮预防工作有关的延迟怀孕认识和耻辱问题。大量饮酒会增加意外怀孕和产前饮酒的风险。因此，美国女性酗酒和意外怀孕的比例很高，表明所有育龄女性都需要进行一级预防。筛查和简短干预 (SBI) 可以减少饮酒，但由于公共卫生保健资源有限，仍未得到充分利用。在医疗保健资源日益减少的经济体中，即将实施的《平价医疗法案》(ACA) 表明迫切需要低成本工具来实现 SBI。我们建议研究一种最近试行的、自我管理的计算机化工具，用于减少产前饮酒，该工具在传统 SBI 的基础上添加了饮酒量评估和饮酒量反馈的新组件。我们将调整这种双语（英语和西班牙语）电子 SBI 或“e-SBI”以供非孕妇使用，并在公共卫生诊所对其功效进行小型试验。我们还将研究饮酒量评估本身的影响以及抑郁症是否会改变 e-SBI 功效。研究结果将有助于设计更大规模的 e-SBI 减少产前饮酒功效的试验。我们将使用实验设计来进行拟议的小型试验。我们将随机分配 150 名过去一年未怀孕且报告饮酒的女性接受 e-SBI 或常规护理。我们将完成基线、3个月和6个月的随访评估，并将饮酒和怀孕作为主要结局，将健康风险（即吸毒、甜饮料和抑郁）作为次要结局。次要结果数据使我们能够检查 e-SBI 的潜在负面影响，并将我们提出的研究与之前的 e-SBI 研究区分开来，这些研究没有检查可能的 SBI 相关不良结果，例如药物使用增加。为了解决先前研究中的方法学局限性，我们将纳入饮酒量评估，以更好地衡量饮酒结果，最大限度地减少基线时对照的评估反应，并在 3 个月的随访中纳入加强 e-SBI。这使我们能够检查饮酒量评估本身是否会减少饮酒，以及其效果是否与完整的 e-SBI 相同。通过这些设计创新，您的研究将提供可以在后续多组试验中进行更严格评估的信息。因为它为 e-SBI 减少产前饮酒功效的 II 期试验奠定了基础，所以我们提出的研究对于改善孕产妇和儿童健康具有重要意义。研究结果还将影响有关减少酒精相关危害的成本效益策略的更广泛的干预文献。