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

调整和测试行为干预措施以预防 FASD 和不良婴儿结局

• 批准号: 10707467
• 负责人: Yukiko Washio
• 金额: $ 23.07万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10707467
• 关键词: Abstinence; Address; Adverse effects; Affect; Alcohol consumption; Alcohols; Animal Model; Behavior Therapy; Behavioral; Biochemical; Birth; Breast Feeding; Cannabinoids; Cannabis; Categories; Centers for Disease Control and Prevention (U.S.); Child; Child Development; Clinic; Clinical; Cognitive; Communities; Confidential Information; Congenital Abnormality; Consolidated Framework for Implementation Research; Cost Effectiveness Analysis; Country; Data; Discipline of obstetrics; Disparity; Education; Effectiveness; Evidence based intervention; Exposure to; Fetal Alcohol Exposure; Fetal Alcohol Spectrum Disorder; Goals; Health; Health Benefit; Health Promotion; Incentives; Infant; Infant Development; Intervention; Lactation; Mission; Modification; Mothers; National Institute on Alcohol Abuse and Alcoholism; Outcome; Phase; Policy Maker; Population; Postpartum Period; Pregnancy; Prevention; Process; Provider; Public Health; Qualitative Research; Randomized; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Research Design; Research Methodology; Research Personnel; South Africa; Testing; Text; Tobacco; Tobacco use; United States; Woman; Women' s Group; Women' s Health; alcohol consumption during pregnancy; brief intervention; cocaine use in pregnancy; contingency management; cost; disorder risk; effectiveness evaluation; effectiveness study; effectiveness testing; evidence base; feasibility testing; follow-up; health disparity; implementation study; infant outcome; intervention cost; marijuana legalization; marijuana use; marijuana use in pregnancy; maternal alcohol use; outcome disparities; policy recommendation; polysubstance use; pregnant; prenatal; prenatal exposure; prevent; programs; response; social disparities; substance use; substance use treatment; success; syndemic; texting support

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.

项目摘要/摘要 描述：陈述该应用程序的广泛，长期目标和具体目标，参考项目的健康相关性（即 与该机构的任务有关）。描述实现既定目标的研究设计和方法。确保项目摘要 反映了拟议项目的关键重点，以便可以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。不要超过提供的空间。 该R61/R33应用程序适应和测试基于证据的行为干预以减少 在怀孕和哺乳期间使用多刺激性（即酒精和烟草/大麻）并防止广告 临床结果，包括南非（SA）的胎儿酒精谱系障碍（FASD）。 SA有很长的时间 社会和健康差异的历史，导致世界上最高的FASD（每1,000）111.1） 终身性认知和身体影响是由于产前酒精暴露而产生的。 FASD完全 如果妇女在怀孕期间不喝酒，则可以预防。产前饮酒经常与其他 使用物质，尤其是烟草和大麻。酒精和酒精对出生结果的不利影响 烟草一起使用比单独的任何一种物质都要差。动物模型的最新证据表明 大麻素和酒精潜力的产前暴露于酒精引起的先天缺陷的可能性。 来自SA的Cape Metropole的数据表明，所有报告产前酒精使用的女性也都进行了测试 烟草使用阳性，还有25％的人报告使用大麻。母乳喂养时还会使用饮酒 以相对高的速度在SA中。尽管有母乳喂养，但孕产妇饮酒带来了巨大的健康益处 母乳喂养显着损害了婴儿的发育。应急管理（CM）已经 在美国（美国）降低产前可卡因，酒精和烟草使用方面有效。女人的 卫生库（WHC）是一种基于证据的简短干预措施，针对以妇女为中心的联合问题 以及与物质和饮酒有关的分布。这些基于证据的干预措施 需要合并和适应用于解决Mater Polysubstance使用和相关的健康以及 SA中怀孕和哺乳期间的行为问题。具体目的如下：（1）R61 AIM 1- 与怀孕或母乳喂养的妇女进行新历史的妇女进行形成性定性研究 PolySubstance使用，诊所和社区利益相关者以及既定的社区合作 木板。 （2）R61 AIM 2 - 适用的干预措施的检验可行性，可接受性和适当性 SA开普大都市中有48名妇女（24名怀孕和24个母乳喂养）。 （3）R33 AIM 1-检查 改编干预的有效性（即，通过WHC教育提供基于CM和基于文本的支持 组件）在2组随机对照试验中，有184位怀孕并随访的妇女 怀孕期间和产后3个月。 （4）R33 AIM 2-对妊娠，出生和 婴儿的结果。 （5）R33 AIM 3 - 轨道成本和进行初步成本效益分析。