A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women with Childhood Adversity

一项改善童年逆境妇女母婴同步性的随机对照试验

• 批准号: 10252948
• 负责人: ALEECA F BELL
• 金额: $ 59.4万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-30 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252948
• 关键词: Adult; Adverse event; Affect; Age-Months; Auditory; Behavior; Behavior Therapy; Behavioral; Biological Markers; Birth; Blood; Brain; Cause of Death; Child; Code; Cognitive deficits; Complex; Consumption; Control Groups; Cost Savings; Cues; DNA Methylation; Development; Disease; Distress; Education; Empathy; Endocrine system; Epigenetic Process; Exhibits; Eye; Frequencies; Functional disorder; Gene Expression; Gene Proteins; Health; Home; Hormones; Household; Human; Immune system; Infant; Infant Behavior; Infant Care; Infant Development; Intervention; Knowledge; Late pregnancy; Learning; Life; Link; Liquid substance; Massage; Maternal Behavior; Measures; Messenger RNA; Methods; Methylation; Modeling; Molecular; Molecular Profiling; Mothers; Nervous system structure; Neuropeptides; Outcome; Oxytocin; Oxytocin Receptor; Pathway interactions; Pattern; Peptides; Peripheral; Physiological; Pilot Projects; Plasma; Population; Premature Infant; Process; Psychopathology; Public Health; Randomized; Randomized Controlled Trials; Receptor Gene; Research Design; Risk; Risk Factors; Rodent; Role; Saliva; Science; Site; Social Adjustment; Social Behavior; Speech; System; Tactile; Testing; Time; Touch sensation; Treatment Efficacy; Visual; Woman; Work; abuse neglect; alertness; attentional control; base; behavior measurement; biological systems; childhood adversity; clinical research site; clinical trial implementation; economic cost; efficacy evaluation; efficacy testing; epigenetic regulation; experience; gaze; group intervention; health disparity; health economics; high risk population; improved; infant outcome; innovation; intervention cost; intervention effect; maternal outcome; member; multisensory; postnatal; prevent; psychosocial; receptor; relating to nervous system; social; social engagement; socioeconomics; stress reactivity; success; visual-vestibular

Childhood adversity (e.g., abuse, neglect, or household dysfunction), is a common experience significantly contributing to the leading causes of death and increased US economic health burdens. Childhood adversity causes long-term alterations on the nervous, endocrine, and immune systems well into adulthood, including dampening of the neuropeptide oxytocin (OXT). A healthy OXT system facilitates responsive social engagement and promotes maternal-infant (M-I) synchrony (reciprocal gaze, affect speech, and touch). Optimal M-I synchrony fuels early brain development and prevents low empathy, disruptive behavior, poor social adaptation, cognitive deficits, and psychopathology in children. We posit that mothers with childhood adversity will have more difficulty with M-I synchrony, due in part to a dampened OXT system, and will benefit from interventions that improve responsive, nurturing, engagement by epigenetic regulation of the OXT system. Most interventions are costly, complex, and time-consuming. We aim to fill this gap by testing whether a simple early behavioral intervention (ATVV) will improve OXT system function and M-I synchrony in mothers with childhood adversity. The ATVV (Auditory, Tactile, Visual, Vestibular) is a 15-minute behavioral intervention consisting of infant- directed speech, moderate touch massage, eye to eye gaze, and horizontal rocking. We extend the known success of ATVV with preterm infants to full-term infants. We will compare M-I synchrony at 3 postnatal months in 250 first-time mothers (and their full-term infants) randomized to apply ATVV daily from birth to 3 months (n = 125) or receive infant care education in an attention control group (n = 125). We apply a rigorous measure of M-I synchrony that micro-codes video-recorded M-I behavior quantifying shared gaze, affect, speech, and touch. Coding requires only 3-minutes of interaction and is valid when infants can reliably interact starting by 3 months of age. We will also assess ATVV's effect on maternal and infant peripheral OXT level, a known biomarker of M-I synchrony. OXT levels relate to quality of M-I synchrony, yet we extend this knowledge to identify an epigenetic role of the oxytocin receptor gene (OXTR). We will analyze maternal plasma for OXTR methylation, OXTR gene expression, OXTR protein, and oxytocin peptide in late pregnancy, and at 1, 2, and 3 postnatal months (along with infant saliva OXT). In summary, aims are to 1) determine effects of daily ATVV, compared with an attention control group, from birth to 3 postnatal months on behavioral and physiologic measures of M-I synchrony in mothers with childhood adversity, and 2) for the first time identify molecular mechanisms in the OXT system underlying M-I synchrony in maternal plasma. Regression based methods (including covariates) will assess ATVV effects on M-I synchrony and OXT measures, and identify relations among M-I synchrony and oxytocin measures. Clustering methods will be used to discover molecular profiles. An early behavioral intervention that successfully promotes M-I synchrony in vulnerable women through epigenetic regulation of the OXT system can then be tested in a multi-site clinical implementation trial with other high-risk groups.

儿童逆境（例如虐待，忽视或家庭功能障碍）是一种普遍的经历 导致死亡的主要原因并增加了美国经济健康负担。童年逆境 直到成年，包括 神经肽催产素（OXT）的阻尼。健康的OXT系统有助于响应迅速的社会参与 并促进产妇（M​​-I）同步（相互视线，影响语音和触摸）。最佳M-I 同步促进早期大脑发育并防止同理心低下，破坏性行为，社会适应不良， 儿童的认知缺陷和心理病理学。我们认为，有童年逆境的母亲会有 M-1同步的更困难，部分原因是oxt系统潮湿，并且将受益于干预措施 通过表观遗传调节，oxt系统的响应迅速，培养，培养。大多数干预措施 昂贵，复杂且耗时。我们的目标是通过测试简单的早期行为来填补这一空白 干预（ATVV）将改善患有儿童逆境的母亲的OXT系统功能和M-I同步。 ATVV（听觉，触觉，视觉，前庭）是15分钟的行为干预措施，由婴儿组成 定向语音，中等触摸按摩，眼睛注视和水平摇摆。我们扩展已知的 ATVV与早产儿为完整婴儿的成功。我们将在三个月后比较M-I同步 在250名初次母亲（及其成熟婴儿）中，每天从出生到3个月就随机申请ATVV（n = 125）或在注意力控制组中接受婴儿护理教育（n = 125）。我们采用严格的措施 M-I同步，微型编码视频记录的M-I行为量化了共享的目光，情感，语音和触摸。 编码仅需要3分钟的交互作用，并且在婴儿可以可靠地互动3个月开始时是有效的 年龄。我们还将评估ATVV对孕产妇和婴儿外围OXT水平的影响，该水平是已知的生物标志物 M-I同步。 OXT级别与M-I同步的质量有关，但是我们扩展了此知识以确定 催产素受体基因（OXTR）的表观遗传作用。我们将分析母体血浆的氧化甲基化， 妊娠晚期的OXTR基因表达，OXTR蛋白和氧蛋白肽，以及1、2和3 几个月（与婴儿唾液OXT一起）。总而言之，目的是1）确定每日ATVV的影响，比较 从注意力控制组中，从出生到三个月的行为和生理测量 童年逆境的母亲的同步，2）首次确定分子机制 母体等离子体中M-1同步的OXT系统。基于回归的方法（包括协变量） 将评估ATVV对M-I同步和OXT措施的影响，并确定M-1同步之间的关系 催产素度量。聚类方法将用于发现分子曲线。早期行为 通过表观遗传调节成功地促进了弱势妇女的M-I同步的干预措施 然后可以在其他高危组的多站点临床实施试验中对OXT系统进行测试。