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

HeartPREP：为患有先天性心脏病的婴儿的母亲提供虚拟的心理社会干预

• 批准号: 10580776
• 负责人: Erica D Sood
• 金额: $ 12.52万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10580776
• 关键词: Address; Affect; Anxiety; Behavior Therapy; Behavioral Model; Behavioral Research; Birth; Black race; Brain; Cardiac Surgery procedures; Cardiology; Caring; Child; Child Health; Child Rearing; Congenital Abnormality; Decision Making; Development; Developmental Delay Disorders; Disease; Distress; Education; Elements; Ethnic Origin; Ethnic Population; Evaluation; Exhibits; Family; Feedback; Fetal Heart; Fetus; Funding; Health system; Hispanic; Hospitalization; Hospitals; Infant; Intervention; Low income; Measures; Medical; Mental Depression; Modeling; Morbidity - disease rate; Mothers; National Heart, Lung, and Blood Institute; Operative Surgical Procedures; Outcome; Outcome Assessment; Outcomes Research; Parents; Participant; Patient-Focused Outcomes; Patients; Personal Satisfaction; Phase; Population; Pregnancy; Pregnant Women; Prenatal Diagnosis; Race; Randomized; Randomized, Controlled Trials; Research; Self Efficacy; Severities; Site; Social isolation; Stress; Structure; Testing; Time; Trauma; Underserved Population; Vulnerable Populations; Well in self; Work; biological adaptation to stress; burden of illness; clinically significant; comparison intervention; congenital heart disorder; design; efficacy trial; emotional distress; fetal; follow-up; hospital readmission; improved; in utero; innovation; intervention refinement; maternal stress; multidisciplinary; pilot test; post intervention; postnatal; prenatal; prenatal experience; provider communication; psychosocial; racial population; recruit; socioeconomics; standard care; telehealth; therapy development; tool; traumatic stress; usability; virtual delivery

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.

项目摘要 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） 受疾病相关疾病的影响。他们更有可能早产， 手术后再次入院，表现出发育迟缓，最终死于冠心病。CHD 越来越多的人在出生前就被诊断出来。虽然产前诊断可能有利于 婴儿，因为它有助于出生后立即进行医疗护理，母亲描述了她们的产前护理， 高度紧张和创伤的经历。母亲在怀孕期间的压力会对 出生结果和发展轨迹，特别是对服务不足人口中的儿童。针对性 没有努力减轻产妇压力对这一高度脆弱群体的影响。在伙伴关系与 不同的父母和临床医生的利益相关者，我们的团队设计了HeartPREP，一个创新的，虚拟交付 对患有CHD的孕妇进行心理社会干预。HeartPREP将以英语提供， 通过Nemours应用程序提供西班牙语，这是一个远程医疗、教育和与 临床医生这项拟议的研究将评估HeartPREP是否能改善孕产妇和家庭结局 产前诊断CHD后。所有研究目标的参与者将是携带 一个被确定患有CHD的胎儿，从内穆尔儿童健康系统的两家医院招募。我们 已经组建了一个专家团队，以家庭为基础的心理社会干预和以病人为中心的结果 研究（目标1）通过15-20名孕妇的大声思考测试来完善HeartPREP，并评估 通过对10名孕妇进行beta测试，确定初步可行性、可用性和可接受性（目标2）， HeartPREP模块是否对结果（情绪困扰， 社会隔离，养育自我效能感，和希望;测量PROMIS）在20个孕妇（证据- 概念）和（目的3）评价HeartPREP与标准护理对照（SCC）相比的影响。六十 怀有被确定为患有CHD的胎儿的孕妇将被随机分配到HeartPREP或SCC， 在干预期间每周对结果进行完整评估（情绪困扰、社会孤立、养育子女 自我效能和希望）以及干预后和产后3个月随访（焦虑、抑郁、创伤性 家庭/家庭功能（family/family functioning）计划在第二年进行的R 01申请将为Aim 3的扩展提供资金， 多中心疗效试验HeartPREP有可能改善孕妇的情绪健康 一个患有CHD的婴儿，从而改变了这一大群儿童的发育轨迹。该模型 然后可以适用于其他出生缺陷（占所有出生的3%），考虑到母亲压力反应的共性， 广泛解决得不到充分服务的人口中与疾病有关的发病率造成的不成比例的负担。