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

计算机传输的针对妊娠期饮酒的 SBIRT：规划 II 期试验

• 批准号: 8251211
• 负责人: STEVEN J. ONDERSMA
• 金额: $ 21.85万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-05 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8251211
• 关键词: Address; Adverse effects; Advisory Committees; African American; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; American College of Obstetricians and Gynecologists; Area; Behavioral; Biological Markers; Birth; Caring; Child; Clinic; Clinical Trials; Cognitive; Communities; Computer software; Computers; Data; Development; Electronic Mail; Ethnic group; Evaluation; Exhibits; Feedback; Fetal Alcohol Spectrum Disorder; Fetal Alcohol Syndrome; Fetal alcohol effects; Grant; Infant; Intervention; Interview; Investments; Lead; Literature; Mails; Medical; Medical Staff; Mental Retardation; Methods; Modification; Mothers; National Institute on Alcohol Abuse and Alcoholism; Nature; Neurocognitive; Nurses; Outcome; Participant; Patient Self-Report; Patients; Perinatal; Phase; Phase II Clinical Trials; Planned Pregnancy; Population; Pregnancy; Pregnant Women; Prenatal care; Primary Health Care; Privacy; Procedures; Process; Race; Randomized Clinical Trials; Recommendation; Reporting; Research; Research Design; Risk; Risk Factors; Sampling; Screening procedure; Series; Societies; Staging; Technology; Time; Touch sensation; Training; Woman; Work; alcohol exposure; base; binge drinking; brief intervention; care systems; cost; cost effective; evidence base; follow-up; handheld mobile device; high risk drinking; life time cost; motivational intervention; novel; pregnant; prenatal; prenatal exposure; primary care setting; public health relevance; reduced alcohol use; screening and brief intervention; screening, brief intervention, referral, and treatment; social; tailored messaging; therapy development; tool

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.

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，并且是智力低下的主要原因。非裔美国人和/或社会经济地位低的女性所生的婴儿似乎面临更高的不良影响风险。筛查、简短干预和转诊治疗 (SBIRT) 方法是解决这一重大需求的一个有前途的选择：许多研究表明，这些方法可以成功地用于初级保健环境中，以识别和减少饮酒，而且其短暂的主动性质使它们有巨大的潜力接触到其他未识别的高危女性。不幸的是，越来越多的证据表明，SBIRT 方法的前景可能会受到其所需的时间、培训、专业知识和承诺的限制。计算机提供的 SB​​IRT 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，需要几个第一阶段步骤。因此，该 R34 应用程序将为计算机交付的 SBIRT 用于怀孕期间饮酒的全功能临床试验奠定基础。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实用性和匿名自我访谈形式在产前诊所筛查患者中的饮酒风险； (2) 修改现有的计算机提供的针对怀孕期间饮酒的动机干预措施，以达到可接受的先验标准（对于专家以及有代表性的孕妇）； (3) 开发基于证据的定制信息补充，以补充单次简短干预； (4) 检查生物标志物乙基葡萄糖苷酸 (EtG) 在孕妇中的有效性和分数； (5) 通过 N = 50 的 I 期随机临床试验收集有关改进的计算机干预措施的可接受性、可行性和估计效果大小的数据。该试验的参与者将是怀孕期间有饮酒风险的不同女性样本，其中大多数是非裔美国人和/或社会经济地位较低的女性。这些关键的准备步骤将极大促进后续R01应用程序的开发，以进行妊娠期饮酒的II期临床试验。这些步骤还将提供以下方面的重要初步数据：(a) 初级保健中风险因素筛查的新方法； (b) EtG 作为怀孕期间和围产期饮酒生物标志物的潜在用途； (c) 仅需要一次联系的完全由计算机提供的、组合的简短交互式/定制消息传递干预的效果大小估计。如果成功，这一系列研究可能会导致针对怀孕期间饮酒的高成本效益、高影响力的干预措施。酒精使用量的减少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：产前接触酒精会对母亲在怀孕期间饮酒的孩子产生持久的负面影响。事实证明，在产前护理机构中对母亲饮酒情况进行简短筛查和干预是有帮助的，但往往没有实施。计算机提供的筛查和简短的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。