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）：测量和减少过多的婴儿哭泣：一名随机试验候选人：Christopher Greeley，医学博士，医学博士，迄今为止最年轻的Helfer获奖者，以预防儿童虐待儿童的临床和倡导成就，并获得了$ 100K临床研究人员在我们的临床研究中获得100K临床研究人员奖励的临床研究计划，以防止临床研究中的临床参与者，以防止虐待儿童。我们的主席最近将他搬到了临床研究和证据医学中心。他的主任乔恩·泰森（Jon Tyson）医学博士，MPH，K12董事兼国家教育，指导奖，围产期和儿科医疗保健研究的董事。指导委员会还包括一位著名的虐待儿童儿科医生，一名发育心理学家和一名临床心理学家，所有联邦资助的研究人员都具有特殊的K23研究专业知识。研究背景。过多的婴儿哭泣（EIC），特别是在晚上，使父母感到困扰，并可能导致虐待儿童。我们的飞行员表明，可以使用剂量计（以与婴儿不同距离的分贝水平记录分贝水平），并以父母可以接受的方式可靠地定量EIC。我们建议充分验证这种方法，并严格测试一套常用的父母舒缓技术，以减少EIC（块上最快乐的婴儿[karp]）。假设。舒缓的技巧教导要研究父母在出生后2-3周研究父母的父母舒缓技巧，并减少婴儿在夜间哭泣（主要结果）和父母的睡眠损失，痛苦和抑郁症，并由8周的蒙面护士在家里评估。方法。由EIC（> 3小时/24H）的单身婴儿通过向我们医院的父母提供的计划（4,700次出生/年）招募的单身婴儿，将在我们的诊所出生后2-3周可见。同意家庭（n = 178）将被随机分为标准的绞痛咨询（美国儿科学会）或干预措施（添加护士教学以及视频和小册子）。在8周时，研究护士将评估父母的睡眠和痛苦（简短的症状清单18），将剂量计在婴儿睡眠和花费大部分时间的房间中，并将Actigraph应用于脚踝。她将在5天后收集这些设备，在通常的喂养时间（可能是EIC）进行体格检查，在接下来的15分钟内使用未引人入胜的，经过验证的方法记录婴儿和孕产妇行为（Tyson，1992），并提供母亲的支持。标准统计测试将使用（alpha = 0.05； beta = 0.20；效应尺寸= 0.5 SD，功率= .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，并准备Greeley博士成为一名富有成效的独立临床研究者和严格设计和进行研究以防止虐待儿童的研究和领导者。公共卫生相关性：过度的婴儿哭泣（EIC）可能会增加虐待儿童的风险。我们根据KARP的建议提出了一项随机试验。我们将系统地识别170名具有EIC的婴儿，并在6-8周龄的家庭中进行进行评估，以测试以下假设：干预措施减少了夜间哭泣的婴儿时间，增加了母亲舒缓的行为并改善了父母的焦虑和抑郁。