Adventures in the Design and Trial of an Innovative FASD Risk Assessment: Integrating Known Risks with New Measures of Weekly Prenatal Alcohol Exposure, Maternal Mental Health, and Paternal Alcohol

创新性 FASD 风险评估的设计和试验中的冒险：将已知风险与每周产前酒精暴露、母亲心理健康和父亲酒精的新措施相结合

• 批准号: 10434286
• 负责人: Philip Alan May
• 金额: $ 23.4万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10434286
• 关键词: Adolescence; Age; Age Months; Alcohol consumption; Alcohols; Anxiety; Behavioral; Birth; Breast Feeding; Cannabis; Categories; Child; Childhood; Clinic; Clinical assessments; Conceptions; Consent; Consultations; Data; Development; Diagnosis; Diagnostic; Dietary intake; Distal; Drug usage; Dysmorphology; Environmental Exposure; Environmental Risk Factor; Environmental and Occupational Exposure; Epigenetic Process; Etiology; Event; Exposure to; Fathers; Feedback; Fetal Alcohol Exposure; Fetal Alcohol Spectrum Disorder; Genetic; Goals; Growth; Growth Disorders; Health; Health Status; Human Milk; Individual; Infrastructure; Interview; Knowledge; Learning; Life; Link; Longitudinal cohort; Longitudinal cohort study; Measures; Mental Depression; Mental Health; Methamphetamine; Methodology; Methods; Moods; Mothers; Outcome; Parents; Participant; Pharmaceutical Preparations; Phase; Post-Traumatic Stress Disorders; Postpartum Period; Predisposition; Pregnancy; Prevention; Prospective Studies; Prospective, cohort study; Protocols documentation; Questionnaires; Recording of previous events; Research; Research Methodology; Retrospective Studies; Risk; Risk Assessment; Risk Estimate; Risk Factors; Severities; Specificity; Stress; Techniques; Teratogens; Time; Toxic Environmental Substances; Trauma; Validation; Violence; Weather; Woman; alcohol and other drug; alcohol exposure; biomarker validation; child bearing; clinical epidemiology; cohort; design; disorder risk; efficacy evaluation; efficacy trial; efficacy validation; experience; improved; innovation; insight; maternal alcohol use; multidisciplinary; novel; offspring; pilot test; prenatal; prospective; recruit; remediation; response; social; trait

Project Abstract/Summary The two-phased research mechanism will permit us to design, pilot test, and validate the efficacy of innovative new multivariate protocols for estimating actual risk for the birth of a child with fetal alcohol spectrum disorders (FASD). In the R61 Phase we will research, create, design, and pilot test new protocols for: 1) interviewing mothers (with biomarker validation) to determine maternal alcohol consumption on a daily/weekly basis across pregnancy and postpartum alcohol use during breastfeeding to assess their specific contributions to child traits and severity of FASD outcomes; 2) determining maternal experience with stress, trauma, and mental health status during pregnancy and their contribution to the severity of effect on FASD diagnostic traits; 3) interviewing fathers regarding paternal traits that contribute to the risk for FASD from exposure to teratogens such as alcohol, other drugs, and environmental toxins during pre-conception; and 4) establishing a comprehensive, summary FASD risk score from the above innovations when combined with multiple other empirically-established proximal and distal variables of risk. The R33 Phase will then initiate an exploration of a multivariate, comprehensive approach to FASD risk via two applications for better understanding FASD etiology. One application is prospective and the other retrospective. In the prospective study, 200 women (and as many of their partners as we can consent) will be recruited from prenatal clinics, and their offspring will be assessed at six weeks and nine months postpartum and diagnosed by pediatric dysmorphologists and a multidisciplinary team. The second application of the new methods will gather the new data retrospectively and link the data to two existing cohorts of maternal/child dyads whom we have followed over time to assess their FASD status and the severity of their physical, neurodevelopmental, and behavioral traits. Both of these studies will add new insight to our long-term quest to understand more completely the respective contributions of a broad range of host, agent, and environmental factors to the etiology of FASD. This R33 Phase will provide substantial validation of the weekly alcohol use data, mental health status assessments, paternal questionnaire, and FASD risk score innovations via the clinical assessment of the offspring of each pregnancy. In developing this more comprehensive approach to FASD risk, both study phases draw on our existing clinical epidemiology infrastructure, the experience of our multi- disciplinary team, and the participants in existing longitudinal cohorts.

项目摘要/摘要 两阶段的研究机制将使我们能够设计，试点测试和验证 创新的新的多变量协议的有效性，估计实际风险的出生， 胎儿酒精谱系障碍（FASD）在R61阶段，我们将研究，创造， 设计和试点测试新的协议：1）采访母亲（生物标志物验证）， 确定母亲在整个怀孕期间每天/每周的饮酒量， 母乳喂养期间产后饮酒，以评估其对儿童特征的具体贡献 FASD结局的严重程度; 2）确定母亲的压力，创伤和 妊娠期间的心理健康状况及其对FASD影响严重程度的影响 诊断特征; 3）采访父亲关于父亲的特征，有助于风险， FASD暴露于致畸剂，如酒精，其他药物和环境毒素， 怀孕前;以及4）根据上述内容建立全面的汇总FASD风险评分 当与多个其他经外科手术建立的近端和远端 风险变量。 然后，R33阶段将开始探索多元、全面的 通过两个应用程序来更好地了解FASD病因。一 一种是前瞻性的，另一种是追溯性的。在这项前瞻性研究中，200名女性（ 我们可以同意的尽可能多的伴侣）将从产前诊所招募，他们的 将在产后6周和9个月对后代进行评估，并由儿科医生进行诊断。 畸形学家和多学科团队。新方法的第二次应用将 回顾性地收集新数据，并将数据与现有的两个孕产妇/儿童队列联系起来 我们随时间推移对他们进行了随访，以评估他们的FASD状态和他们的严重程度。 身体、神经发育和行为特征。这两项研究将为我们提供新的见解， 我们长期寻求更全面地了解广泛的各个领域的贡献， 宿主、病原体和环境因素对FASD病因学的影响。本R33阶段将提供 每周饮酒数据的实质性验证，心理健康状况评估， 问卷调查，和FASD风险评分创新，通过临床评估的后代， 每次怀孕。在开发这种更全面的FASD风险方法时， 阶段利用我们现有的临床流行病学基础设施，我们的多个经验， 学科团队和现有纵向队列的参与者。