Alcohol and Contraception Risk Reduction Internet Intervention to Prevent FASD

描述(申请人提供)：胎儿酒精谱系障碍(FASD)，包括胎儿酒精综合症，导致巨大的社会和经济成本。胎儿酒精暴露会导致一系列后果，从轻微的学习和社交问题到对儿童面部、大脑、器官和健康的悲剧性永久损害。酒精暴露妊娠(AEP)被定义为任何怀孕期间妇女在任何时间饮酒，并可能导致FASD。如果饮酒妇女防止意外怀孕，或者如果打算怀孕的妇女减少或戒酒，AEP及其后遗症的初级预防是可能的。已经开发了有效的干预措施来降低AEP的风险，但还没有得到广泛的应用。在这个项目中，我们将开发一种新型的互联网干预措施，通过将两个研究团队的资源结合起来，分别专注于FASD的初级预防和强大的互联网干预，以降低AEP风险。我们将使用我们的循证AEP降低风险干预材料和我们现有的互联网干预开发平台，在第一阶段行为和综合疗法开发项目中建立并试点测试互联网干预(避孕和降低酒精风险互联网干预，CARI)。这个为期三年的R34项目将开发和规划新的互联网干预，并将在试点RCT中确定干预的可行性和初步效果。在干预措施的开发阶段，我们将使用专家顾问来调整基于证据的选择干预措施，以便为创建吸引人的计划提供信息，获取用户输入，修改计划以最大化可行性、吸引力和影响，然后在有风险的用户中反复进行试点测试。一旦干预措施最终完成，我们将在一项试验性随机对照试验中评估CARI针对患者教育网站情况的可行性和初步疗效，评估时间为前、后和6个月。试验性随机对照试验的参与者将包括70名有AEP风险的妇女。将使用标准的、可靠的预测因素、协变量、过程变量和结果的测量方法。主要结果将是每天饮酒，由预期自我报告日记和TLFB相结合来衡量，其次是避孕无效的事件。分析将涉及其他连续的结果指标，包括暴饮暴食的数量、酗酒天数和受保护的性行为事件的数量，将使用重复测量ANOVA进行分析。在探索性分析中，我们将使用我们的互联网干预模型来识别用户特征、网站使用变量，并改变预测AEP风险降低的机制。我们将为未来在更大的随机对照研究中进行成本效益评估做准备，然后对拟议的措施进行试点测试。试验性随机对照试验将为随后的全功率试验产生效果大小估计。如果互联网干预是有希望的，那么它应该在一场全面的全国性试验中进行测试。互联网干预可以大大增加AEP预防的选择，并可能导致事件FASD的减少。

DESCRIPTION (provided by applicant): Fetal Alcohol Spectrum Disorders (FASDs), including Fetal Alcohol Syndrome, lead to enormous societal and financial costs. Fetal alcohol exposure can result in a range of outcomes from mild learning and social problems to tragic permanent damage to the child's face, brain, organs, and health. Alcohol-exposed pregnancy (AEP) has been defined as any pregnancy during which a woman drank any alcohol at any time, and can result in FASD. Primary prevention of AEP and its sequelae is possible if drinking women prevent unintended pregnancy, or if women intending pregnancy reduce or eliminate drinking. Efficacious interventions to reduce the risk of AEP have been developed, but are not widely available. In this project, we will develop a novel Internet intervention to reduce AEP risk by combining the resources of two research teams focused on primary prevention of FASD and robust Internet interventions, respectively. We will use our evidence- based AEP risk reduction intervention materials and our existing Internet intervention development platform to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction Internet Intervention, CARRI) in a stage 1 behavioral and integrative therapies development project. This three year R34 project will develop and program the new Internet intervention, and will determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. During the intervention development phase, we will adapt the evidence-based CHOICES intervention using expert consultants to inform the creation of an appealing program, obtain user input, modify the program to maximize feasibility, appeal, and impact, and then pilot test it with users at risk iteratively. Once the intervention is finalized, we will assess the feasibility and preliminary efficacy of CARRI against a Patient Education Website condition in a pilot RCT with assessments at pre-, post-, and 6 months. Participants in the pilot RCT will include 70 women who are at risk for AEP. Standard, reliable measures of predictors, covariates, process variables, and outcomes will be used. The primary outcome will be drinks per drinking day measured by the combination of prospective self-report diaries and the TLFB, with a secondary outcome of episodes of ineffective contraception. Analyses will address additional continuous outcome markers including number of binges, number of heavy drinking days, and number of protected sexual intercourse events, to be analyzed using repeated measures ANOVAs. In exploratory analyses, we will use our Model of Internet interventions to identify user characteristics, website use variables, and change mechanisms that predict AEP risk reduction. We will prepare for a future cost effectiveness evaluation in the larger RCT to follow by pilot testing proposed measures. The pilot RCT will yield effect size estimates for a subsequent fully powered trial. If the Internet intervention is promising, it should be tested in a fully powered national trial. The Internet intervention could substantially increase the options for AEP prevention, and could lead to a reduction in incident FASD.