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: 8117157
• 负责人: Christopher S Greeley
• 金额: $ 10.63万
• 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/8117157
• 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泣：一项随机试验候选人：克里斯托弗格里利，医学博士，最年轻的Helfer获奖者迄今为止的临床和宣传成就，在儿童虐待预防和接受者的10万美元临床研究奖的杰出参与者在我们的MS临床研究计划，致力于成为严格的研究，以防止虐待儿童的领导者。我们的主席最近把他调到了临床研究和循证医学中心。他是由其董事，乔恩泰森，医学博士，公共卫生硕士，K12主任和国家奖的教育，导师，围产期和儿科保健研究的收件人指导。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，他们都是联邦政府资助的调查人员，对这项K23研究具有特殊的专业知识。研究背景。过度的婴儿哭泣（EIC），特别是在晚上，会使父母感到痛苦，并可能导致虐待儿童。我们的试点表明，EIC可以在家里可靠地量化使用剂量计（记录分贝水平在不同距离的婴儿）和手表一样的活动记录仪（记录腿部运动）在父母接受的方式。我们建议充分验证这种方法，并严格测试一套常用的父母安抚技术，以减少EIC（快乐的婴儿在块[卡普]）。假设。安抚技术教学习父母出生后2-3 wks增加父母的安抚技能，并减少婴儿在夜间哭泣（主要结果）和父母的睡眠不足，痛苦，抑郁症在家里评估由一个蒙面护士在8 wks. Methods。通过我们医院提供给父母的计划招募的EIC（> 3小时/24小时）足月单胎婴儿（4，700例出生/年）将在出生后2-3周在我们的诊所就诊。将接受治疗的家庭（n=178）随机分为标准绞痛咨询组（美国儿科学会）或干预组（增加护士指导加上视频和小册子）。在8周时，研究护士将评估父母的睡眠和痛苦（简明症状量表-18），将剂量计放置在婴儿睡眠和大部分时间呆在的房间中，并将活动记录仪应用于脚踝。她将在5天后收集这些装置，在通常的喂养时间（可能发生EIC时）进行体格检查，使用不引人注目的、经验证的方法（Tyson，1992）记录婴儿和母亲在接下来15分钟的哭泣/喂养期间的行为，并在需要时提供母亲支持。将使用标准统计检验（α =0.05; β = 0.20;效应量=0.5 SD，把握度= 0.90）。 上述教育、指导和研究将增强评估和解决EIC的方法，并使格里利博士成为一名富有成效的独立临床研究者，并在严格设计和进行的研究中发挥领导作用，以防止虐待儿童。 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。我们提出了一项随机试验，采用基于卡普建议的干预措施。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，以检验干预减少婴儿夜间哭泣的平均时间，增加母亲安抚行为并改善父母焦虑和抑郁的假设。