Adapting and testing a behavioral intervention to prevent FASD and adverse infant outcomes

项目总结/摘要 描述：说明申请的广泛、长期目标和具体目标，并参考项目的健康相关性（即， 与原子能机构的使命相关）。描述研究设计和实现既定目标的方法。确保项目摘要 反映了拟议项目的重点，以便对应用程序进行适当的分类。不包括专有/机密 信息或商业秘密。不要超过所提供的空间。 该R61/R33申请建议调整和测试基于证据的行为干预，以减少 多物质使用（即，酒精和烟草/大麻），并防止不良 临床结果，包括南非（SA）的胎儿酒精谱系障碍（FASD）。A长 社会和健康差距的历史，导致世界上最高的FASD率（每1，000人111.1），其中 产前酒精暴露会对认知和身体产生终身的负面影响。FASD完全是 如果妇女在怀孕期间不喝酒，可以预防。产前酒精使用经常与其他并发症同时发生 药物使用，特别是烟草和大麻。酒精对出生结果的不利影响， 同时使用烟草比单独使用任何一种物质都要糟糕。最近的动物模型证据表明， 产前接触大麻素和酒精会增加酒精引起的出生缺陷的可能性。 来自南非大都会角的数据显示，所有报告产前饮酒的妇女也进行了测试。 烟草使用呈阳性，25%的人还报告使用大麻。母乳喂养时饮酒也会发生 在南澳的比例相对较高。尽管母乳喂养对健康有巨大的好处， 而母乳喂养严重损害婴儿发育。应急管理（CM） 有效减少产前可卡因，酒精和烟草的使用在美国（美国）。妇女 健康合作计划（WHC）是一项以证据为基础的简短干预措施，旨在解决以女性为重点的综合征问题 以及由此产生的与物质和酒精使用相关的差异。这些基于证据的干预措施 需要加以结合和调整，以解决产妇使用多种药物和相关健康问题， 行为问题在怀孕和哺乳期在SA。具体目标如下：（1）R61目标1- 对近期怀孕或哺乳的妇女进行形成性定性研究 多物质使用，诊所和社区利益相关者，以及一个既定的社区合作 纸板. (2)R61目标2-测试适应性干预的可行性、可接受性和适当性， 48例女性（24例妊娠和24例哺乳），来自Cape Metropole，SA。(3)R33目标1-检查 适应性干预的有效性（即，CM和基于文本的支持与WHC教育 在一项2组随机对照试验中，184名孕妇和随访 怀孕期间和产后3个月。(4)R33目标2-检查对妊娠、分娩和 婴儿的结果。(5)R33目标3-跟踪成本并进行初步的成本效益分析。

PROJECT SUMMARY/ABSTRACT DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe the research design and methods for achieving the stated goals. Be sure that the project summary reflects the key focus of the proposed project so that the application can be appropriately categorized. Do not include proprietary/confidential information or trade secrets. DO NOT EXCEED THE SPACE PROVIDED. This R61/R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA. The Specific Aims are as follows: (1) R61 Aim 1— Conduct formative qualitative research with women who are pregnant or breastfeeding with a recent history of polysubstance use, clinic and community stakeholders, and an established Community Collaborative Board. (2) R61 Aim 2—Test feasibility, acceptability, and appropriateness of the adapted intervention with 48 women (24 pregnant and 24 breastfeeding) in Cape Metropole, SA. (3) R33 Aim 1—Examine the effectiveness of the adapted intervention (i.e., CM and text-based support with WHC educational components) in a 2-group randomized controlled trial with 184 women who are pregnant and follow up during pregnancy and 3 months postpartum. (4) R33 Aim 2—Examine the impact on gestational, birth, and infant outcomes. (5) R33 Aim 3—Track cost and conduct preliminary cost-effectiveness analyses.