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

基本信息

批准号：
8451591
负责人：
STEVEN J. ONDERSMA
金额：
$ 20.32万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
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/8451591
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 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 screening and brief intervention screening, brief intervention, referral, and treatment social tailored messaging therapy development tool

项目摘要

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.

描述（由申请人提供）：产前暴露于酒精会对注意力，认知，社会和行为领域的功能产生持久影响，并且是造成智力低下的主要原因。非裔美国人和/或低SES妇女出生的婴儿似乎有不良反应的风险。筛查，简短的干预和治疗方法（SBIRT）方法是满足这一重大需求的有前途的选择：许多研究表明，这些方法可以在初级保健环境中成功使用，以识别和减少酒精的使用，并且它们的短暂积极主动的性质赋予了他们在其他未知未知的处于危险中的潜力。不幸的是，越来越多的证据表明，SBIRT方法的承诺可能受到所需的时间，培训，专业知识和承诺的限制。通过计算机交付的SBIRT方法可以通过低成本提供一致的筛查和基于证据的简短干预措施来解决此限制，而无需向医务人员提供大量时间或精力。但是，在进行II期临床试验之前，必须进行几个阶段I步骤。因此，此R34应用将为一项在怀孕期间用于饮酒的计算机销售SBIRT的临床试验奠定基础。它将通过进行五项关键初步研究来做到这一点，包括：（1）评估手持移动设备的效用以及一种匿名的自我采访格式，以筛查在产前诊所的患者中处于危险中的饮酒；（2）修改现有的计算机传递的动机干预妊娠期间的饮酒，以确定可接受的标准（对专家和代表性的孕妇）；（3）开发基于循证的量身定制的消息补充，以简短干预措施；（4）检查孕妇的生物标志物葡萄糖醛酸乙酰葡萄糖醛酸乙酯（ETG）的有效性和降低分数；（5）通过n = 50阶段的随机临床试验，收集有关修饰的计算机交付干预措施的可接受性，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饮酒危险的各种样本，其中大多数将是非裔美国人和/或SES。这些关键的预备步骤将极大地促进随后开发R01应用，以进行II期临床试验，以在怀孕期间进行饮酒。这些步骤还将提供有关（a）新颖的初级保健风险因素筛查方法的重要初步数据；（b）ETG作为怀孕期间和围产期饮酒的生物标志物的潜在效用；（c）完全计算机交付的简短交互式/量身定制的消息干预措施的效果尺寸估计值仅需要一次触点。如果成功的话，这项研究可能会导致怀孕期间对饮酒的高度效率高度高的干预；这些减少酒精的减少可能会对胎儿酒精谱系疾病产生有意义的影响。