Alcohol and Contraception Risk Reduction Internet Intervention to Prevent FASD

描述（由申请人提供）：胎儿酒精谱系障碍（FASD），包括胎儿酒精综合征，导致巨大的社会和经济成本。胎儿酒精暴露会导致一系列结果，从轻微的学习和社会问题到对孩子的面部、大脑、器官和健康造成悲惨的永久性损害。酒精暴露妊娠（AEP）被定义为女性在任何时间饮用任何酒精的任何妊娠，并可能导致FASD。AEP及其后遗症的一级预防是可能的，如果饮酒的妇女防止意外怀孕，或如果妇女打算怀孕减少或消除饮酒。已经开发了降低AEP风险的有效干预措施，但尚未广泛使用。在这个项目中，我们将开发一种新的互联网干预，以减少AEP的风险，通过结合两个研究团队的资源，分别专注于FASD的一级预防和强大的互联网干预。我们将使用我们基于证据的AEP风险降低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构建和试点测试互联网干预（避孕和酒精风险降低互联网干预，CARRI）。这个为期三年的R34项目将开发和规划新的互联网干预，并将在一个试点RCT中确定干预的可行性和初步疗效。在干预开发阶段，我们将使用专家顾问来调整基于证据的CHOICES干预，以告知有吸引力的计划的创建，获取用户输入，修改计划以最大限度地提高可行性，吸引力和影响力，然后反复对处于风险中的用户进行试点测试。一旦干预措施最终确定，我们将在一项试点RCT中评估CARRI对患者教育网站状况的可行性和初步疗效，并在术前、术后和6个月进行评估。试验RCT的参与者将包括70名有AEP风险的女性。将使用标准、可靠的预测因子、协变量、过程变量和结局指标。主要结局将是通过前瞻性自我报告日记和TLFB相结合测量的每个饮酒日的饮酒量，次要结局是无效避孕发作。分析将涉及额外的连续结果标志物，包括狂欢次数、大量饮酒天数和保护性性交事件次数，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预测AEP风险降低的用户特征、网站使用变量和变化机制。我们将准备在更大的随机对照试验中进行未来的成本效益评估，然后对拟议的措施进行试点测试。试点RCT将为后续的完全把握度试验提供效应量估计值。如果互联网干预是有希望的，它应该在一个充分的国家试验测试。互联网干预可以大幅增加AEP预防的选择，并可能导致FASD事件的减少。

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.