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: 7962795
• 负责人: Christopher S Greeley
• 金额: $ 11.97万
• 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/7962795
• 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 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; 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; Violence; 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泣：随机试验候选人：Christopher Greeley，医学博士，迄今为止在预防儿童虐待方面取得临床和倡导成就的最年轻的Helfer奖获得者，也是我们临床研究项目中杰出参与者的10万美元临床研究者奖的获得者，致力于成为防止儿童虐待的严格研究的领导者。我们的主席最近将他调到临床研究和循证医学中心。他是由其董事Jon Tyson，医学博士，公共卫生硕士，K12董事和国家教育，指导，围产期和儿科医疗保健研究奖获得者指导的。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员，具有K23研究的特殊专业知识。研究背景。婴儿过度啼哭（EIC），特别是在夜间，使父母感到痛苦，并可能导致虐待儿童。我们的试点表明，EIC可以在父母可以接受的方式下，使用剂量计（记录与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）在家中可靠地量化。我们建议充分验证这一方法，并严格测试一套常用的父母安抚技巧来减少EIC （The最快乐的婴儿[Karp]）。假设。在婴儿出生后2-3周，研究父母的安抚技巧增强了父母的安抚技巧，减少了婴儿夜间哭泣（主要结果），减少了父母的睡眠不足、痛苦和抑郁，并在8周时由一名蒙面护士在家评估。方法。通过我们医院为父母提供的项目（每年4700名新生儿）招募的EIC足月单胎婴儿（bbb30小时/24小时）将在出生后2-3周在我们的诊所就诊。同意的家庭（n=178）将随机分配到标准的绞痛咨询组（美国儿科学会）或干预组（增加护士指导、视频和小册子）。在8周时，一名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觉和花费最多时间的房间，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的时候）进行体检，在接下来的15分钟内使用不唐突的、经过验证的方法记录婴儿和母亲在哭泣/喂养期间的行为（Tyson, 1992），并在需要时提供母亲支持。将使用标准统计检验（alpha=0.05; beta = 0.20；效应大小=0.5 SD，功率= 0.90）。上述教育、指导和研究将加强评估和解决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，并在严格设计和实施防止虐待儿童的研究方面发挥领导作用。