HeartPREP: A virtually-delivered psychosocial intervention for mothers expecting a baby with congenital heart disease

项目总结 先天性心脏病(CHD)是最常见的出生缺陷。CHD影响所有种族、民族和 社会经济群体，但服务不足的人群(例如，低收入黑人和西班牙裔患者)是 不成比例地受到与疾病相关的疾病的影响。他们更有可能早产，可能是 手术后再次入院，表现出发育迟缓，最终死于冠心病。先心病 在种族/民族群体中越来越多地被产前诊断。虽然产前诊断可能对 婴儿在出生后立即进行医疗护理，母亲们描述她们的产前 有高度压力和创伤的经历。孕期母亲的压力对 出生结果和发展轨迹，特别是对服务不足人口中的儿童。目标明确 目前缺乏努力减轻产妇压力对这一高度脆弱人口的影响。与以下公司合作 不同的家长和临床医生利益相关者，我们的团队设计了HeartPREP，一种创新的虚拟交付 预产儿先天疾病母亲的心理社会干预HeartPREP将以英语和 通过Nemour App使用西班牙语，这是一个可访问的工具，可用于远程医疗、教育和与 临床医生。这项拟议的研究将评估HeartPREP是否能改善产妇和家庭结果 在产前诊断为冠心病之后。所有研究目标的参与者将是不同的孕妇携带 一名被确认患有先天性心脏病的胎儿，从内穆尔儿童健康系统内的两家医院招募。我们 已经组建了一个以家庭为基础的心理社会干预和以患者为中心的结果专家团队 通过对15-20名孕妇进行有声思考测试来提炼心脏事件相关电位的研究和评估 通过对10名孕妇进行Beta测试，初步确定可行性、可用性和可接受性(目标2) 心脏PREP模块是否在临床上显著改善了结果(情绪困扰， 社会隔离、育儿自我效能感和希望；用Promis测量)对20名孕妇(证据 概念)，和(目标3)评估与标准护理控制(SCC)相比的心脏PREP的影响。六十 怀着被确认患有冠心病的胎儿的孕妇将被随机分配到HeartPREP或SCC，并将 在干预期间每周完成对结果的评估(情绪困扰、社会孤立、养育子女 自我效能感和希望)以及干预后和产后3个月的随访(焦虑、抑郁、创伤 压力和夫妻/家庭功能)。计划于第二年推出的R01应用程序将为AIM 3扩展为 一项多点疗效试验。HeartPREP有可能改善孕妇的情绪健康 一个患有先天性心脏病的婴儿，从而改变了这一大群儿童的发育轨迹。这款车 然后可以适应其他出生缺陷(占所有出生的3%)，考虑到母亲应激反应的共性， 广泛地解决服务不足人群中与疾病相关的疾病造成的不成比例的负担。

PROJECT SUMMARY Congenital heart disease (CHD) is the most common birth defect. CHD affects all racial, ethnic, and socioeconomic groups, yet underserved populations (e.g., low-income Black and Hispanic patients) are disproportionally affected by disease-related morbidities. They are more likely to be delivered preterm, to be readmitted to the hospital after surgery, to exhibit developmental delays, and ultimately, to die from CHD. CHD is increasingly diagnosed prenatally across racial/ethnic groups. While prenatal diagnosis can be beneficial for the infant in that it facilitates medical care immediately following birth, mothers describe their prenatal experiences as highly stressful and traumatic. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. Targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. In partnership with diverse parent and clinician stakeholders, our team designed HeartPREP, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HeartPREP will be delivered in English and Spanish through the Nemours App, an accessible tool for telehealth, education, and communication with clinicians. The proposed study will evaluate whether HeartPREP improves maternal and family outcomes following prenatal diagnosis of CHD. Participants across all study aims will be diverse expectant mothers carrying a fetus identified as having CHD, recruited from two hospitals within the Nemours Children’s Health System. We have assembled a team of experts in family-based psychosocial intervention and patient-centered outcomes research to (Aim 1) refine HeartPREP through Think Aloud Testing with 15-20 expectant mothers and evaluate initial feasibility, usability, and acceptability through beta testing with 10 expectant mothers, (Aim 2) determine whether HeartPREP modules produce clinically significant improvements on outcomes (emotional distress, social isolation, parenting self-efficacy, and hope; measured by PROMIS) in 20 expectant mothers (Proof-of- Concept), and (Aim 3) evaluate the impact of HeartPREP compared to standard care control (SCC). Sixty expectant mothers carrying a fetus identified as having CHD will be randomized to HeartPREP or SCC and will complete assessment of outcomes weekly during intervention (emotional distress, social isolation, parenting self-efficacy, and hope) and at post-intervention and 3-month postnatal follow-up (anxiety, depression, traumatic stress, and couple/family functioning). An R01 application planned for Year 2 would fund expansion of Aim 3 into a multi-site efficacy trial. HeartPREP has the potential to improve the emotional wellbeing of mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children. This model can then be adapted for other birth defects (3% of all births), given commonalities in maternal stress reactions, broadly addressing the disproportionate burden of disease-related morbidities in underserved populations.