Measuring and Reducing Excessive Infant Crying: A Randomized Trial

测量和减少婴儿过度哭泣：随机试验

基本信息

批准号：
8277934
负责人：
Christopher S Greeley
金额：
$ 10.75万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-26 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8277934
关键词：
Abdominal colic Academy Accident and Emergency department Achievement Address Advocacy Affect Age Air American Ankle Anxiety Award Behavior Birth Blinded Chairperson Child Child Abuse Child abuse prevention Childhood Clinic Clinical Clinical Investigator Clinical Investigator Award Clinical Research Commit Consent Counseling County Crying Development Devices Distress Education Educational process of instructing Equipment and supply inventories Ethnic Origin Evidence Based Medicine Exhibits Family Frustration Funding Goals Habits Health Services Research Home environment Hospitals Hour Incidence Infant Infant Behavior Infanticide Intervention Leg Masks Maternal Behavior Measurement Measures Mental Depression Mentors Mentorship Methods Mothers Movement Noise Nurses Nurses&apos instruction Outcome Pamphlets Parents Participant Pediatrics Perinatal Population Pregnancy Psychologist Randomized Recommendation Records Recruitment Activity Reporting Research Research Personnel Risk SECTM1 gene Shaken baby syndrome Siblings Sleep Symptoms Techniques Testing Texas Time Traumatic Brain Injury base coping design exhaust feeding group intervention improved intervention effect maternal cigarette smoking mother&apos s soothing pediatrician perpetrators prevent primary outcome programs public health relevance randomized trial response routine care sex skills

项目摘要

DESCRIPTION (provided by applicant): Measuring and Reducing Excessive Infant Crying: A Randomized Trial Candidate: Christopher Greeley, MD, the youngest Helfer Awardee to date for clinical and advocacy achievements in child abuse prevention and a recipient of a $100K Clinical Investigator Award for outstanding participants in our MS Program in Clinical Research, is committed to becoming a leader in rigorous research to prevent child abuse. Our Chairman recently moved him to the Center for Clinical Research and Evidence Based Medicine. He is mentored by its director, Jon Tyson, MD, MPH, a K12 director and recipient of national awards for education, mentorship, and perinatal and pediatric health care research. The mentorship committee also includes a prominent child abuse pediatrician, a developmental psychologist, and a clinical psychologist, all federally funded investigators with special expertise for this K23 research. Study Background. Excessive infant crying (EIC), particularly at night, distresses parents and may precipitate child abuse. Our pilot indicates that EIC can be reliably quantitated in the home using dosimeters (to record decibel levels at different distances from the infant) and a watch-like actigraph (to record leg movement) in a manner acceptable to parents. We propose to fully validate this method and rigorously test a commonly used set of parental soothing techniques to reduce EIC (The Happiest Baby on the Block [Karp]). Hypotheses. The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks. Methods. Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90). The education, mentoring, and research noted above will enhance the methods to assess & address EIC and prepare Dr. Greeley to become a productive and independent clinical investigator and leader in rigorously designed and conducted research to prevent child abuse. PUBLIC HEALTH RELEVANCE: Excessive infant crying (EIC) is likely to increase the risk of child abuse. We propose a randomized trial using an intervention based on recommendations of Karp. We will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.

描述（由申请人提供）：测量和减少婴儿过度哭泣：随机试验候选人：克里斯托弗·格里利（Christopher Greeley）医学博士，迄今为止最年轻的 Helfer 奖获得者，因其在预防儿童虐待方面的临床和宣传成就而获得 10 万美元临床研究者奖我们临床研究硕士项目的杰出参与者致力于成为防止虐待儿童的严格研究的领导者。我们的主席最近将他调往临床研究和循证医学中心。他受到其主任 Jon Tyson（医学博士、公共卫生硕士）的指导，他是 K12 主任，也是教育、指导以及围产期和儿科保健研究国家奖项的获得者。指导委员会还包括一位著名的虐待儿童儿科医生、一位发展心理学家和一位临床心理学家，所有这些都是联邦资助的研究人员，对这项 K23 研究具有特殊的专业知识。研究背景。婴儿过度哭泣（EIC），尤其是在晚上，会让父母感到痛苦，并可能导致虐待儿童。我们的试点表明，可以在家中使用剂量计（记录距婴儿不同距离的分贝水平）和手表式活动记录仪（记录腿部运动）以父母可以接受的方式可靠地定量 EIC。我们建议充分验证该方法，并严格测试一套常用的父母安抚技术，以减少 EIC（街区最快乐的婴儿 [Karp]）。假设。在出生后 2-3 周向研究父母教授的舒缓技巧增强了父母的抚慰技巧，减少了婴儿夜间哭闹（主要结果），并在出生后 8 周由蒙面护士在家中评估了父母的睡眠不足、痛苦和抑郁。方法。通过我们医院向父母提供的计划（每年 4,700 名新生儿）招募的患有 EIC 的足月单胎婴儿（> 3 小时/24 小时）将在出生后 2-3 周到我们的诊所就诊。同意的家庭 (n=178) 将被随机分配接受标准绞痛咨询（美国儿科学会）或干预（添加护士指导以及视频和小册子）。在第 8 周时，研究护士将评估父母的睡眠和痛苦（简要症状清单 - 18），将剂量计放置在婴儿睡眠和花费最多时间的房间中，并在脚踝处应用活动记录仪。她将在 5 天后收集设备，在通常的喂养时间（可能发生 EIC 时）进行体检，使用不引人注目的、经过验证的方法记录接下来 15 分钟哭闹/喂养期间婴儿和母亲的行为（Tyson，1992），并在需要时提供产妇支持。将使用标准统计检验（α = 0.05；β = 0.20；效应大小 = 0.5 SD，功效 = .90）。上述教育、指导和研究将增强评估和解决 EIC 的方法，并使 Greeley 博士成为一名富有成效和独立的临床研究者，以及严格设计和开展防止虐待儿童的研究的领导者。公共卫生相关性：婴儿过度哭泣 (EIC) 可能会增加虐待儿童的风险。我们根据卡普的建议提出了一项使用干预措施的随机试验。我们将系统地识别 170 名患有 EIC 的足月婴儿，并在 6-8 周龄时在家中进行评估，以检验以下假设：干预措施可减少婴儿夜间哭泣的平均时间、增加母亲的安抚行为并改善父母的焦虑和抑郁。