Computer-delivered SBIRT for alcohol use in pregnancy: Planning a Stage II trial

描述(由申请人提供)：产前接触酒精会对注意力、认知、社交和行为领域的功能产生持久影响，是导致智力低下的主要原因。非裔美国人和/或低SES妇女所生的婴儿似乎面临更高的不良反应风险。筛查、短暂干预和转诊治疗(SBIRT)方法是解决这一重大需求的一个有希望的选择：许多研究表明，这些方法可以成功地用于初级保健环境中，以识别和减少酒精使用，其短暂的主动性使其具有接触其他身份不明的高危妇女的巨大潜力。不幸的是，越来越多的证据表明，SBIRT方法的前景可能受到它们所需的时间、培训、专业知识和承诺的限制。计算机提供的SBIRT方法可以通过以低成本提供一致的筛查和基于证据的简短干预来解决这一限制，而不需要医务人员投入大量的时间或精力。然而，在进入第二阶段临床试验之前，几个第一阶段的步骤是必要的。因此，这一R34应用程序将为计算机提供的用于怀孕期间酒精使用的SBIRT的全功率临床试验奠定基础。它将通过进行五项关键的初步研究来实现这一点，其中包括：(1)评估手持移动设备和匿名自访形式在产前诊所筛查高危饮酒患者中的效用；(2)修改现有的计算机传递的怀孕期间饮酒动机干预措施，使之成为(专家和有代表性的孕妇)可接受的先验标准；(3)为单次简短干预开发基于证据的定制信息补充；(4)检查生物标记物乙基葡萄糖苷(EtG)在孕妇中的有效性并降低其得分；以及(5)通过一项N=50的I期随机临床试验，收集关于改良的计算机传递干预的可接受性、可行性和估计效果大小的数据。这项试验的参与者将是怀孕期间有饮酒风险的妇女的不同样本，其中大多数将是非裔美国人和/或低SES。这些关键的准备步骤将极大地促进R01应用程序的后续开发，以进行怀孕期间酒精使用的第二阶段临床试验。这些步骤还将为以下方面提供重要的初步数据：(A)初级保健中风险因素筛选的新方法；(B)EtG作为孕期和围产期饮酒生物标志物的潜在用途；(C)只需一名联系人的完全电脑传递的、综合的简短互动/量身定制的信息干预的效果大小估计。如果成功，这一系列研究可能导致对怀孕期间酒精使用的高成本效益、高覆盖范围的干预；这些酒精使用的减少反过来可能对胎儿酒精谱系障碍产生有意义的人口影响。 公共卫生相关性：产前接触酒精会对母亲在怀孕期间饮酒的孩子产生持久的负面影响。在产前护理环境中对母亲饮酒进行简短的筛查和干预已被证明是有帮助的，但往往没有得到实施。计算机提供的筛查和短暂干预可能更容易实施。因此，拟议的项目将进行一系列重要的初步研究，旨在为全面的临床试验奠定基础。

DESCRIPTION (provided by applicant): Prenatal exposure to alcohol can have lasting effects on functioning in attentional, cognitive, social, and behavioral domains, and is a major cause of mental retardation. Infants born to African-American and/or low SES women appear to be at increased risk of adverse effects. Screening, brief intervention, and referral for treatment (SBIRT) approaches are a promising option for addressing this significant need: many studies have suggested that these approaches can be successfully used in primary care settings to identify and reduce alcohol use, and their brief proactive nature gives them substantial potential for reaching otherwise unidentified at-risk women. Unfortunately, growing evidence suggests that the promise of SBIRT approaches may be limited by the amount of time, training, expertise, and commitment they require. Computer-delivered SBIRT approaches may address this limitation by providing consistent screening and evidence-based brief interventions, at low cost, without requiring substantial investments of time or energy from medical staff. However, several Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and an anonymous self-interview format in screening for at-risk drinking among patients attending a prenatal clinic; (2) modification of an existing computer-delivered motivational intervention for alcohol use during pregnancy, to a priori standards of acceptability (to experts as well as representative pregnant women); (3) development of an evidence-based tailored messaging supplement to the single-session brief intervention; (4) examining the validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and (5) collecting data on the acceptability, feasibility, and estimated effect size of the modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial. Participants in this trial will be a diverse sample of women at-risk for alcohol use during pregnancy, the majority of whom will be African-American and/or low SES. These key preparatory steps will greatly facilitate the subsequent development of an R01 application to conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also provide important preliminary data on (a) a novel method for risk factor screening in primary care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in the perinatal period; and (c) the effect size estimate for a fully computer-delivered, combined brief interactive/tailored messaging intervention requiring only a single contact. If successful, this line of research could lead to a highly cost-effective, high-reach intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn have a meaningful population impact on Fetal Alcohol Spectrum Disorders. PUBLIC HEALTH RELEVANCE: Prenatal exposure to alcohol can have lasting negative effects on children whose mothers used alcohol during pregnancy. Brief screening and intervention for maternal alcohol use in prenatal care settings has been shown to be helpful, but is often not implemented. Computer-delivered screening and brief intervention may be much easier to implement. The proposed project will therefore conduct a series of crucial preliminary studies designed to lay the groundwork for a full-scale clinical trial.