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

据报道，美国近十分之一的孕妇在过去一个月中饮酒。强有力的证据将产前联系起来 酒精暴露与一系列称为胎儿酒精谱系障碍(FASD)的疾病， 后果包括大脑体积减少，神经化学和连接相关的异常， 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、短期干预和转诊治疗(SBIRT) 被美国妇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/胎儿酒精影响国家工作队。SBIRT有明确的 优势，包括(A)其积极和普遍的做法；(B)使用单一的激励会议 这是足够简短的，足以被高比例的患者接受，即使是那些对 治疗。不幸的是，提供商的时间、培训和保真度是SBIRT的巨大障碍 执行和执行方面的挑战与效力的降低有关。技术-- 交付的SBIRT(e-SBIRT)可能会解决这些障碍。E-SBIRT需要更少的时间和培训 作为提供者的一部分，有助于披露，并可以完美地传播。在第一次随机化 E-SBIRT在孕妇中的试验，我们开发了单次e-SBIRT，获得了很高的满意度 对于戒酒和积极的出生结局，评级和产生的优势比在中等范围内。一个 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SBIRT，优于增强型常规护理，成本低得多。然而，这种令人兴奋的潜力必须 在实施之前进行仔细的优化和验证。拟议的研究将建立在试点试验的基础上 通过测试干预措施是否减少了酒精阳性筛查阳性孕妇的酒精使用量 风险。我们还将使用干预优化技术(多阶段优化策略，或MOST)来 评估可通过以下方式添加后续助推器会话来增强干预效果的程度 参与者自己的移动设备和/或定制的文本消息。具体来说，我们将(A)敲定助推器 具有迭代参与者反馈的会议和文本消息内容，以及(B)随机分配怀孕 女性酒精风险筛查呈阳性(N=384)至3(无短暂干预；一次治疗；或一次治疗 加两个助剂)×2(短信存在或不存在)析因试验。初步分析将测试剂量- 电子干预对孕期饮酒反应的影响。二次分析将检查Main 以及定制短信的交互效应，以及对出生结果的干预效应。探索性的 分析将检查理论驱动的干预效果的调解者和调节者，以及干预 对其他与饮酒有关的结果的影响(例如，酗酒天数)。如果成功，拟议的研究 将产生一种优化的、实用的、易于传播的预防FASD的方法。

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.