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

描述（由申请人提供）：产前暴露于酒精可能对注意力，认知，社会和行为领域的功能产生持久影响，并且是精神发育迟滞的主要原因。非洲裔美国人和/或低社会经济地位的妇女所生的婴儿似乎有更大的不良反应风险。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，以识别和减少酒精使用，其短暂的主动性使其具有很大的潜力，可以接触到其他身份不明的高危妇女。不幸的是，越来越多的证据表明，SBIRT方法的承诺可能受到时间，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II期临床试验之前，需要进行几个I期步骤。因此，R34的应用将为计算机提供的SBIRT在怀孕期间使用酒精的完全有效的临床试验奠定基础。它将通过进行五项关键的初步研究来做到这一点，包括：（1）评价手持移动的设备和匿名自我访谈形式在产前诊所就诊的病人中筛查危险饮酒的效用;（2）修改现有的计算机提供的动机干预怀孕期间使用酒精，先验的可接受性标准（针对专家和孕妇代表）;（3）为单次简短干预编写一份有针对性的循证信息补充材料;（4）检查孕妇中生物标志物乙基葡萄糖醛酸苷（EtG）的有效性和截分;（5）通过N = 50的I期随机临床试验收集关于改良计算机递送干预的可接受性、可行性和估计效应量的数据。这项试验的参与者将是一个多样化的样本，妇女在怀孕期间使用酒精的风险，其中大多数将是非洲裔美国人和/或低社会经济地位。这些关键的准备步骤将极大地促进R 01申请的后续开发，以进行妊娠期间饮酒的第二阶段临床试验。这些步骤还将提供重要的初步数据：（a）初级保健中风险因素筛查的新方法;（B）EtG作为妊娠期和围产期酒精使用生物标志物的潜在效用;以及（c）仅需单次接触即可进行完全计算机交付的组合简短交互式/定制消息传递干预的效应量估计。如果成功的话，这一系列的研究可能会导致一个高成本效益，高范围的干预怀孕期间的酒精使用;这些减少酒精使用反过来可能会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：产前接触酒精可能对母亲在怀孕期间饮酒的儿童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简短干预可能更容易实施。因此，拟议的项目将进行一系列关键的初步研究，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.