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，并且是智力迟钝的主要原因。非裔美国人和/或低社会经济地位妇女所生的婴儿似乎有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机构，以识别和减少酒精使用，其短暂的主动性质使其具有很大的潜力，可以接触到其他未识别的高危妇女。不幸的是，越来越多的证据表明，SBIRT方法的前景可能受到时间、培训、专业知识和承诺的限制。计算机提供的SBIRT方法可以通过提供一致的筛查和以证据为基础的简短干预，以低成本解决这一限制，而不需要医务人员投入大量时间或精力。然而，在进入II期临床试验之前，需要几个I期步骤。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的全面临床试验奠定基础。它将通过进行五项关键的初步研究来实现这一目标，包括：(1)评估手持移动设备的效用，以及在产前诊所就诊的患者中筛查高危饮酒的匿名自我访谈形式；(2)修改现有的计算机提供的怀孕期间饮酒动机干预，使其符合可接受的先验标准（专家和有代表性的孕妇）；(3)为单次简短干预提供基于证据的信息补充；(4)检查孕妇中生物标志物乙基糖甙（EtG）的有效性和评分；(5)通过一项N = 50的I期随机临床试验，收集改进的计算机传递干预的可接受性、可行性和估计效应量的数据。本试验的参与者将是有怀孕期间饮酒风险的不同女性样本，其中大多数是非裔美国人和/或低社会经济地位。这些关键的准备步骤将极大地促进R01申请的后续发展，以进行怀孕期间饮酒的II期临床试验。这些步骤还将为以下方面提供重要的初步数据：(a)在初级保健中筛查风险因素的新方法；(b) EtG作为孕期和围产期酒精使用的生物标志物的潜在效用；(c)仅需要一次接触即可实现的完全由计算机交付的综合简短互动/定制消息传递干预的效应大小估计。如果成功，这一系列的研究可能会导致对怀孕期间饮酒的高成本效益、高可及性干预；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。

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.