Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.
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DOI:
10.1136/bmjopen-2022-062735
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发表时间:
2022-08-03
期刊:
影响因子:
2.9
通讯作者:
Yonkers, Kimberly A.
Yonkers, Kimberly A.
中科院分区:
医学3区
文献类型:
--
作者:
Ondersma, Steven J.;Todd, Lisa;Jablonski, Samantha;Ahuja, Chaarushi;Gilstad-Hayden, Kathryn;Goyert, Gregory;Loree, Amy;Heffner, Jaimee;Yonkers, Kimberly A.

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在美国,大约七分之一的孕妇报告上个月饮酒。强有力的证据将产前酒精暴露与一系列不良围产期结局联系起来,包括称为胎儿酒精谱系障碍的一系列疾病。筛查和简短干预(SBI)已被推荐给孕妇,但已被证明难以实施。这项研究将测试单次技术交付的SBI(电子SBI)在怀孕期间使用酒精的有效性,同时在3×2析因试验中评估定制短信和/或助推器会议的可能额外益处。这项全面析因试验将使用在线广告和诊所传单招募符合不健康酒精使用标准的孕妇,并将她们随机分配到六种条件之一,包括三个级别的短暂干预(无,单次120分钟的会议和单次会议加上两个5分钟的助推器)和两个级别的定制短信(无vs每周两次消息)。主要分析将检测短暂干预对戒酒的剂量反应效应,戒酒定义为妊娠34周前90天内没有自我报告饮酒,指甲样本的乙基葡萄糖醛酸苷分析结果为阴性。次要分析将检查定制短信的主要和交互作用以及对出生结果的干预作用。伦理批准由密歇根州立大学生物医学和健康机构审查委员会提供(编号Y 00005298)。研究结果将在会议和社区论坛上公布,并发表在同行评审的期刊上。将公开提供证明足够有效性和安全性的干预内容。ClinicalTrials.gov注册表(NCT 04332172)。
Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose–response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks’ gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. ClinicalTrials.gov Registry (NCT04332172).
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