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（FASDs），包括胎儿酒精综合征，导致巨大的社会和经济成本。胎儿酒精暴露可导致一系列后果，从轻微的学习和社会问题到对儿童面部、大脑、器官和健康的悲剧性永久性损伤。酒精暴露怀孕（AEP）被定义为任何怀孕期间妇女在任何时间饮用任何酒精，并可能导致FASD。如果饮酒妇女能够预防意外怀孕，或者如果打算怀孕的妇女减少或消除饮酒，就有可能对AEP及其后遗症进行初级预防。减少急性心绞痛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，我们将结合两个研究小组的资源，分别专注于FASD的一级预防和强大的互联网干预，开发一种新的互联网干预措施，以降低AEP的风险。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，在行为和综合治疗开发项目的第一阶段中建立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。在干预措施开发阶段，我们将利用专家顾问对基于证据的CHOICES干预措施进行调整，以制定有吸引力的方案，获取用户的意见，修改方案以最大限度地提高可行性、吸引力和影响，然后在有风险的用户中进行迭代试验。一旦干预完成，我们将在一项试验性随机对照试验中评估CARRI在患者教育网站条件下的可行性和初步疗效，并在术前、术后和6个月进行评估。这项试验性随机对照试验的参与者将包括70名有AEP风险的女性。将使用标准、可靠的预测指标、协变量、过程变量和结果。主要结果将是通过前瞻性自我报告日记和TLFB结合测量的每天饮酒量，次要结果是无效避孕的发作。分析将涉及其他连续结局指标，包括酗酒次数、重度饮酒天数和保护性性交次数，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。我们将准备未来在更大的随机对照试验中进行成本效益评估，然后对拟议的措施进行试点测试。该试点随机对照试验将为随后的全动力试验产生效应量估计。如果互联网干预是有希望的，它应该在一个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.