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

基本信息

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
项目类别：
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&apos s Group Women&apos 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

项目摘要

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.

项目概要/摘要描述：说明应用程序的广泛、长期目标和具体目标，并参考项目的健康相关性（即，描述实现既定目标的研究设计和方法。确保项目摘要。反映了拟议项目的重点，以便可以对应用程序进行适当分类不包括专有/机密。信息或商业秘密不得超出所提供的空间。该 R61/R33 应用建议调整和测试基于证据的行为干预措施，以减少怀孕和哺乳期间使用多种物质（即酒精和烟草/大麻）并预防不良反应临床结果，包括胎儿酒精谱系障碍 (FASD) 在南非 (SA) 具有悠久的历史。社会和健康差异的历史，导致了世界上最高的 FASD 发病率（每 1,000 人 111.1 人），其中胎儿酒精谱系障碍（FASD）对认知和身体造成终生的负面影响。如果女性在怀孕期间不饮酒，那么产前饮酒是可以预防的。药物使用，尤其是烟草和大麻，酒精和大麻对出生结果的不利影响。动物模型的最新证据表明，同时使用烟草比单独使用任何一种物质更糟糕。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。来自南澳州开普梅特波尔的数据显示，所有报告产前饮酒的女性也进行了测试吸烟呈阳性，25% 的人还报告说，母乳喂养期间也曾吸食大麻。尽管母乳喂养对健康有巨大好处，但孕产妇饮酒的比例相对较高。而母乳喂养会严重影响婴儿的发育。有效减少美国产前可卡因、酒精和烟草的使用。健康合作社 (WHC) 是一项基于证据的简短干预措施，旨在解决以女性为中心的流行病问题以及由此产生的与物质和酒精使用相关的差异。需要进行组合和调整，以解决孕产妇多物质使用和相关健康问题 SA 怀孕和哺乳期间的行为问题具体目标如下： (1) R61 目标 1— 对有近期病史的怀孕或哺乳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已建立的社区协作董事会 (2) R61 目标 2——测试调整后的干预措施的可行性、可接受性和适当性。南澳州开普梅特波尔的 48 名妇女（24 名怀孕，24 名哺乳）(3) R33 目标 1 — 检查适应性干预措施（即 CM 和 WHC 教育的基于文本的支持）的有效性一项 2 组随机对照试验，受试者为 184 名怀孕妇女并进行随访 (4) R33 目标 2——检查对妊娠、分娩和生育的影响 (5) R33 目标 3——跟踪成本并进行初步成本效益分析。