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 说明：说明应用程序的广泛、长期目标和具体目标，并参考项目与健康相关的内容(即， 与该机构的使命相关)。描述为实现所述目标而进行的研究设计和方法。请确保项目摘要 反映拟议项目的主要重点，以便对应用程序进行适当分类。不包括专有/机密 信息或商业机密。不要超过所提供的空间。 此R61/R33应用程序建议调整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种物质(即酒精和烟草/大麻)，并防止不良反应 临床结果，包括南非(SA)的胎儿酒精谱障碍(FASD)。Sa有很长一段时间 社会和健康差距的历史，导致世界上FASD比率最高(每1,000人中有111.1人)，其中 出生前接触酒精会对认知和身体造成终生负面影响。FASD完全是 如果女性在怀孕期间不喝酒，是可以预防的。产前经常饮酒与其他 物质使用，特别是烟草和大麻。酒精和酒精对分娩结局的不良影响 同时使用烟草比单独使用任何一种物质都更糟糕。最近来自动物模型的证据表明 产前接触大麻素和酒精都会增加酒精导致出生缺陷的可能性。 来自南卡罗来纳州大都会角市的数据显示，所有报告产前饮酒的女性也进行了测试 烟草使用呈阳性，25%的人还报告使用大麻。在母乳喂养时饮酒也会发生 在南非，这一比例相对较高。尽管母乳喂养对健康有极大的好处，但母亲饮酒 而母乳喂养严重损害了婴儿的发育。应急管理(CM)一直是 在美国有效地减少产前可卡因、酒精和烟草的使用。女子组 健康合作(WHC)是一种以证据为基础的简短干预措施，旨在解决以妇女为重点的综合征问题 以及由此导致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 需要结合和调整，以解决孕产妇多物质使用和相关健康问题 SA患者孕期和哺乳期的行为问题。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、临床和社区利益相关者以及已建立的社区协作 冲浪板。(2)R61目标2-测试适应性干预的可行性、可接受性和适当性 南非大都会角市的48名妇女(24名孕妇和24名哺乳期妇女)。(3)R33目标1-检查 适应干预措施的有效性(即，CM和以文本为基础的对WHC教育的支持 在一项两组随机对照试验中，对184名怀孕和随访的妇女进行了 孕期和产后3个月。(4)R33目标2-检查对妊娠、分娩和 婴儿结局。(5)R33目标三轨成本，并进行初步成本效益分析。