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），包括胎儿酒精综合症，会导致巨大的社会和财务成本。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，并可能导致胎儿酒精谱系障碍 (FASD)。如果饮酒的女性能够防止意外怀孕，或者打算怀孕的女性减少或消除饮酒，那么 AEP 及其后遗症的一级预防是可能的。降低 AEP 风险的有效干预措施已经开发出来，但尚未广泛应用。在这个项目中，我们将结合两个分别专注于 FASD 一级预防和强有力的互联网干预的研究团队的资源，开发一种新颖的互联网干预措施来降低 AEP 风险。我们将使用基于证据的 AEP 风险降低干预材料和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措施，并将在试点随机对照试验中确定干预措施的可行性和初步效果。在干预开发阶段，我们将利用专家顾问调整基于证据的 CHOICES 干预措施，以指导创建有吸引力的计划，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，然后与面临风险的用户迭代进行试点测试。一旦干预最终确定，我们将在试点随机对照试验中针对患者教育网站条件评估 CARRI 的可行性和初步功效，并在术前、术后和 6 个月进行评估。试点随机对照试验的参与者将包括 70 名有 AEP 风险的女性。将使用预测变量、协变量、过程变量和结果的标准、可靠的度量。主要结果是通过前瞻性自我报告日记和 TLFB 相结合来衡量每个饮酒日的饮酒量，次要结果是无效避孕事件的发生。分析将涉及其他连续结果标记，包括暴饮暴食的次数、酗酒的天数和受保护的性交事件的次数，并使用重复测量方差分析进行分析。在探索性分析中，我们将使用互联网干预模型来识别用户特征、网站使用变量以及预测 AEP 风险降低的改变机制。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，然后对提议的措施进行试点测试。试点随机对照试验将为后续的全面试验提供效应大小估计。如果互联网干预有希望，就应该在全面的国家试验中进行测试。互联网干预可以大大增加 AEP 预防的选择，并可能导致 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.