Measuring and Reducing Excessive Infant Crying: A Randomized Trial

测量和减少婴儿过度哭泣：随机试验

• 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
• 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' 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' s soothing; pediatrician; perpetrators; prevent; primary outcome; programs; public health relevance; randomized trial; response; routine care; sex; skills

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闹：随机试验候选人：克里斯托弗·格里利医学博士，他是迄今为止在防止虐待儿童方面取得临床和倡导成就的最年轻的Helfer奖获得者，也是我们临床研究MS项目杰出参与者获得的10万美元临床研究人员奖的获得者，他致力于成为防止虐待儿童的严谨研究的领导者。我们的主席最近把他调到了临床研究和循证医学中心。他的导师是Jon Tyson，医学博士，公共卫生硕士，K12董事，教育、导师以及围产期和儿科保健研究的国家奖项获得者。指导委员会还包括一名著名的儿童虐待儿科医生、一名发展心理学家和一名临床心理学家，他们都是联邦政府资助的调查人员，具有这项K23研究的特殊专业知识。研究背景。过度的婴儿哭闹(EIC)，特别是在晚上，会让父母感到痛苦，并可能引发虐待儿童的事件。我们的试点表明，使用剂量计(记录离婴儿不同距离的分贝水平)和类似手表的活动记录仪(记录腿部运动)，可以在家里以父母可以接受的方式可靠地量化EIC。我们建议充分验证这一方法，并严格测试一套常用的父母抚慰技术，以减少EIC(The Happiest Baby on the Block[Karp])。假设。在出生后2-3周研究父母的抚慰技巧可以增强父母的抚慰技能，并减少婴儿夜间哭泣(主要结果)和8周时由蒙面护士在家中评估的父母失眠、痛苦和抑郁。方法：研究方法。通过本院为父母提供的计划招募的患有EIC(3小时/24小时)的足月单胎婴儿(4,700胎/年)将在出生后2-3周在我们的诊所看到。同意的家庭(n=178)将随机接受标准的绞痛咨询(美国儿科学会)或干预(增加护士指导加上视频和小册子)。在8周后，研究护士将评估父母的睡眠和痛苦(简明症状清单-18)，在婴儿睡觉和花费最多时间的房间放置剂量计，并在脚踝处应用活动记录仪。她将在5天后收集这些设备，在正常的喂养时间(当EIC可能发生时)进行体检，使用不引人注目的、经过验证的方法记录婴儿和母亲在接下来的15分钟内的哭闹/喂养行为(Tyson，1992)，并根据需要提供母亲支持。将使用标准统计检验(α=0.05；β=0.20；效应大小=0.5SD，幂=0.90)。上面提到的教育、指导和研究将增强评估和解决EIC的方法，并使Greeley博士准备成为一名富有成效的独立临床研究员和领导者，在严格设计和进行防止虐待儿童的研究方面。 公共卫生相关性：婴儿过度哭闹(EIC)可能会增加虐待儿童的风险。我们建议进行一项基于Karp建议的干预的随机试验。我们将系统地识别170名患有EIC的足月婴儿，并在6-8周大的家庭中进行评估，以检验干预措施减少婴儿平均夜间哭闹时间、增加母亲抚慰行为并改善父母焦虑和抑郁的假设。