Scaling up: A multi-site trial of e-SBI for alcohol use in Pregnancy

扩大规模：针对妊娠期饮酒的 e-SBI 多中心试验

• 批准号: 10270064
• 负责人: STEVEN J. ONDERSMA
• 金额: $ 51.7万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10270064
• 关键词: Scaling; up; multi; site; trial

Nearly 1 in 10 pregnant women in the U.S. report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a spectrum of conditions known as Fetal Alcohol Spectrum Disorders (FASDs), with consequences including reductions in brain volume, neurochemical and connectivity-related abnormalities, executive functioning deficits, and preterm birth. The burden of these consequences is disproportionately borne by African-Americans. Screening, Brief Intervention, and Referral for Treatment (SBIRT) has been recommended as a key intervention for pregnant women by the American College of Obstetricians & Gynecologists and the National Task Force on Fetal Alcohol Syndrome/Fetal Alcohol Effect. SBIRT has clear advantages, including (a) its proactive and universal approach; and (b) its use of a single motivational session that is brief enough to be acceptable to a high proportion of patients, even among those with little interest in treatment. Unfortunately, provider time, training, and fidelity are tremendous obstacles for SBIRT implementation, and implementation challenges are associated with reductions in effectiveness. Technology- delivered SBIRT (e-SBIRT) may address these obstacles. e-SBIRT requires far less time and training on the part of providers, facilitates disclosure, and can be disseminated with perfect fidelity. In the first randomized trial of e-SBIRT with pregnant women, we developed a single-session e-SBIRT that received high satisfaction ratings and yielded odds ratios in the medium range for alcohol abstinence and a positive birth outcome. A subsequent trial with women in a reproductive health setting showed this approach to be equivalent to person- delivered SBIRT and superior to enhanced usual care, at far less cost. This exciting potential, however, must be optimized and validated carefully prior to implementation. The proposed study will build upon the pilot trial by testing whether the intervention reduces alcohol use among pregnant women screening positive for alcohol risk. We will also use intervention optimization techniques (Multiphase Optimization Strategy, or MOST) to evaluate the extent to which intervention effects can be enhanced by adding subsequent booster sessions via participants’ own mobile devices, and/or tailored text messaging. Specifically, we will (a) finalize booster session and text message content with iterative participant feedback, and (b) randomly assign pregnant women screening positive for alcohol risk (N = 384) to a 3 (no brief intervention; one session; or one session plus two boosters) X 2 (SMS present or not present) factorial trial. The primary analysis will test for dose- response effects of the e-intervention on alcohol use during pregnancy. Secondary analyses will examine main and interaction effects of tailored text messaging, as well as intervention effects on birth outcomes. Exploratory analyses will examine theory-driven mediators and moderators of intervention efficacy, as well as intervention effects on additional drinking-related outcomes (e.g., days of binge use). If successful, the proposed study would yield an optimized, practical, and readily disseminated method for prevention of FASD.

在美国，近十分之一的孕妇报告上个月饮酒。有力的证据表明产前 酒精暴露与一系列条件称为胎儿酒精谱系障碍（FASD）， 后果包括脑容量减少，神经化学和连接相关异常， 执行功能缺陷和早产这些后果的负担是不成比例的 由非裔美国人承担。筛查、短暂干预和转诊治疗（SBIRT）已被 被美国产科医师学会推荐为孕妇的关键干预措施， 妇科医生和胎儿酒精综合征/胎儿酒精效应国家工作队。SBIRT已明确 优势，包括（a）其积极主动和普遍的方法;和（B）其单一激励会议的使用 这足够简短，可以被高比例的患者接受，即使是那些对 治疗不幸的是，提供者的时间、培训和保真度是SBIRT的巨大障碍 实施和实施挑战与有效性的降低有关。技术- 交付的SBIRT（e-SBIRT）可以解决这些障碍。e-SBIRT所需的时间和培训要少得多， 作为提供者的一部分，便于披露，并可以完全忠实地传播。在第一次随机 在对孕妇进行e-SBIRT的试验中，我们开发了一种单次e-SBIRT，获得了很高的满意度 结果表明，在中等范围内，戒酒和积极的出生结果的比值比。一 随后在生殖健康环境中对妇女进行的试验表明，这种方法相当于人- 提供了SBIRT和上级增强的常规护理，成本低得多。然而，这种令人兴奋的潜力必须 在实施之前进行优化和仔细验证。拟议的研究将以试验性试验为基础 通过测试干预措施是否能减少酒精检测呈阳性的孕妇的酒精使用， 风险我们还将使用干预优化技术（多阶段优化策略，或MOST）， 评估通过增加后续加强疗程可以增强干预效果的程度， 参与者自己的移动的设备和/或定制的文本消息。具体而言，我们将（a）完成助推器 具有迭代参与者反馈的会话和文本消息内容，以及（B）随机分配怀孕 酒精风险筛查阳性的女性（N = 384）至3级（无短暂干预;一个疗程;或一个疗程 加两个加强剂）X2（SMS存在或不存在）析因试验。主要分析将测试剂量- 电子干预对怀孕期间饮酒的反应效果。次要分析将检查主要分析 定制短信的互动效应，以及对出生结果的干预效应。探索性 分析将研究理论驱动的中介和干预效果的主持人，以及干预 对其他饮酒相关结果的影响（例如，使用的时间）。如果成功，拟议的研究 将产生用于预防FASD的优化的、实用的和容易传播的方法。