Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies Supplement

产前酒精暴露(PAE)会增加患胎儿酒精谱系障碍(FASD)的风险。致信地址 这一健康威胁，我们提议在纽约大学、德克萨斯大学的研究人员之间开展一项令人兴奋的合作 健康科学中心-休斯顿、普渡大学和CIFASD开发、实施和评估酒精 对妇女产前护理的干预。我们提出了一项随机对照试验(N=600)来评估疗效 酒精干预，相对于通常的产前护理，在减少(1)妇女饮酒和2)贫穷方面 婴儿出生结局。我们将在妇女第一次产前检查时招募她们。资格标准包括(1)年龄&>18岁 年；(2)≤怀孕8周；(3)最近几年EtG尿液快速检测呈阳性 前三周饮酒或自我报告饮酒，以及(4)书面知情同意。合资格 妇女完成由项目研究护士(PRN)进行的基线评估，该评估由ACASI和 采集血迹进行血液生化分析，以评估饮酒情况。随后，女性被 随机分为(1)干预条件，通常的产前加酒精干预，或(2) 对比情况，仅限常规产前检查。产前常规护理包括临床医生评估酒精使用情况 并就与酒精相关的风险向女性提供咨询。酒精干预包括(1)一台自定进度的计算机- 提供组件，以增强减少酒精的知识、规范和动机，以及(2)PRN- 提供部分，以加强计算机提供的内容，并解决妇女问题。两者都有 组件是理论驱动的，基于激励增强理论(MET)，并使用激励 促进减少饮酒的战略。酒精干预是在多个组织的指导下发展起来的 资料来源，包括：(1)项目的妇女咨询委员会；从拟议的征聘诊所征聘 世卫组织自我报告怀孕期间饮酒情况，以及(2)项目调查人员和顾问拥有广泛的 在研究和试验设计以及开发和实施SBIRT方面的经验和专业知识 妇女，包括孕妇，酗酒和其他药物的使用。酒精干预是在 三次：(1)在基线和第二和第三个三个月评估之后。妇女被随机分配到 只接受常规的产前护理，按照与干预中的妇女相同的时间表完成评估 条件。我们将使用广义估计方程模型和意向治疗分析来评估 干预条件相对于常规产前护理条件在(1)提高比例方面的效果 在怀孕期间经实验室确认的peth测试呈阴性的妇女，以及(2)减少 婴儿中不良分娩结局的比例。建议的研究是科学的和临床的。 意义重大。如果证明有效，该干预措施可能代表了一种可扩展的减少酒精策略 适用于其他妇产医院和临床点的产前临床护理，减少产前酒精 暴露和不良生育后果。如果成功，这将是CIFASD的第一次预防干预。

Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders (FASD). To address this health threat, we propose an exciting collaboration between researchers at NYU, the University of Texas Health Science Center-Houston, Purdue University, and CIFASD to develop, implement, and evaluate an alcohol intervention for women in prenatal care. We propose a randomized controlled trial (N=600) to assess the efficacy of the alcohol intervention, relative to usual prenatal care only, in reducing (1) women’s alcohol use and 2) poor infant birth outcomes. We will recruit women at their first prenatal care visit. Eligibility criteria include (1) age >18 years; (2) ≤8 weeks gestation; (3) a positive rapid point-of-care ethyl glucuronide (EtG) urine test for recent alcohol use or self-reported alcohol use in the prior three weeks, and (4) written informed consent. Eligible women complete a baseline assessment by a Project Research Nurse (PRN) consisting of an ACASI and collection of bloodspots for PEth analysis to assess alcohol consumption biologically. Subsequently, women are randomized to either (1) the intervention condition, the usual prenatal plus the alcohol intervention, or (2) the comparison condition, usual prenatal care only. Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks. The alcohol intervention consists of (1) a self-paced computer- delivered component to enhance knowledge, norms, and motivation for alcohol reduction and (2) a PRN- delivered component to reinforce the computer-delivered content and address women’s questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction. The alcohol intervention is developed with guidance from multiple sources, including (1) the project’s Women’s Advisory Board; recruited from the proposed recruitment clinics who self-report alcohol use during pregnancy, and (2) project investigators and consultants with extensive experience and expertise in research and trial design, and developing and implementing SBIRTs for reducing alcohol use and other drugs among women, including pregnant women. The alcohol intervention is delivered on three occasions: (1) following the baseline and the 2nd- and 3rd-trimester assessments. Women randomized to receive usual prenatal care only complete assessments on the same schedule as women in the intervention condition. We will use generalized estimating equation models and an intent-to-treat analysis to evaluate the efficacy of the intervention condition relative to the usual prenatal care condition in (1) increasing the proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy and (2) reducing the proportion of adverse birth outcomes among infants. The proposed research is scientifically and clinically significant. If demonstrated effective, the intervention may represent a scalable alcohol reduction strategy suitable for prenatal clinical care in other maternity hospitals and clinical sites to reduce prenatal alcohol exposure and adverse birth outcomes. If successful, this would be the first prevention intervention for CIFASD.