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: 10686027
• 负责人: STEVEN J. ONDERSMA
• 金额: $ 49.69万
• 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/10686027
• 关键词: Abstinence; Address; Advisory Committees; Affect; African American population; Alcohol consumption; American College of Obstetricians and Gynecologists; Birth; Birth Weight; Cells; Child; Disclosure; Dose; Effectiveness; Ethics; Executive Dysfunction; Exhibits; Family; Feedback; Fetal Alcohol Exposure; Fetal Alcohol Spectrum Disorder; Fetal Alcohol Syndrome; Fetal Death; Fetal alcohol effects; Friends; Health; Health Care Costs; Healthcare; Healthcare Systems; Intellectual functioning disability; Intensive Care; Intention; Intervention; Leeches; Live Birth; Mediating; Mediator; Mental Depression; Methods; Motivation; Neonatal Intensive Care; Odds Ratio; Outcome; Participant; Patients; Persons; Pregnancy; Pregnant Women; Premature Birth; Prevention; Provider; Public Health; Race; Randomized; Recommendation; Reporting; Reproductive Health; Risk; Self Determination; Severities; Site; Techniques; Technology; Testing; Text Messaging; Time; Training; Treatment Efficacy; Woman; alcohol abstinence; alcohol risk; behavioral health; brain volume; brief intervention; cost; disorder prevention; drinking; effectiveness evaluation; executive function; handheld mobile device; implementation barriers; interest; intervention effect; multi-site trial; multiphase optimization strategy; neurochemistry; pilot trial; public health priorities; randomized effectiveness trial; reduced alcohol use; response; satisfaction; scale up; screening; screening, brief intervention, referral, and treatment; secondary analysis; statistics; tailored text messaging; theories; treatment as usual

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，将近十分之一的孕妇报告了过去的月份饮酒。有力的证据连接产前 酒精暴露，具有称为胎儿酒精谱系（FASD）的各种疾病，带有 后果包括减少脑体积，神经化学和连通性异常， 执行功能定义和早产。这些后果的燃烧不成比例 由非裔美国人承担。筛查，简短干预和治疗转诊（SBIRT）已有 建议作为美国产科学院对孕妇的关键干预和 妇科医生和国家胎儿酒精综合征/胎儿酒精效应。 Sbirt清晰 优势，包括（a）其主动和普遍的方法； （b）使用一次励志会议 这是足够的简短，以至于很大比例的患者也可以接受，即使在那些对 治疗。不幸的是，提供者时间，培训和忠诚是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）可能会解决这些障碍。 E-Sbirt所需的时间要少得多，培训 提供者的一部分，促进披露，并可以以完美的保真度进行传播。在第一个随机中 与孕妇的E-Sbirt试验，我们开发了一项单次E-Sbirt，获得了很高的满意 评级和产生戒酒和阳性出生结果的中等比值比。一个 随后在生殖健康环境中与妇女进行的试验表明，这种方法等同于人 以较低的成本交付了SBIRT，优于增强的通常护理。但是，这种令人兴奋的潜力必须 在实施之前，请先仔细地对其进行优化和验证。拟议的研究将基于试点审判 通过测试干预措施是否减少了孕妇的酒精饮酒效果 风险。我们还将使用干预优化技术（多相优化策略，或大多数） 通过通过添加随后的助推器会话来评估可以增强干预效果的程度 参与者自己的移动设备和/或量身定制的文本消息传递。具体来说，我们将（a）最终确定助推器 会议和短信内容与迭代参与者的反馈，以及（b）随机分配怀孕 妇女筛查酒精风险阳性（n = 384）至3（没有简短的干预；一次会议；或一次会议 加上两个助推器）x 2（SMS存在或不存在）阶乘试验。主要分析将测试剂量 电子干预对怀孕期间饮酒的反应影响。次要分析将检查主要 量身定制的文本消息传递以及干预对出生结果的影响。探索性 分析将检查理论驱动的介体和干预效率的主持人以及干预措施 对其他与饮酒有关的结果的影响（例如，使用暴饮暴食的天数）。如果成功，拟议的研究 将产生一种预防FASD的优化，实用且容易传播的方法。