THE PERIOD OF PURPLE CRYING: KEEPING BABIES SAFE IN NORTH CAROLINA

描述(由申请人提供)：我们建议测试全州范围内的初级预防干预措施，使新生儿的父母准备好安全和明确地处理婴儿哭泣，是否可以减少入院人数和虐待性头部创伤(AHT)的死亡。我们计划既教育父母，又促进文化变革，了解婴儿哭闹的性质，并对其做出适当的反应。我们将审查影响这一干预的调解人和主持人，进行过程评估，并评估该计划的有效性和成本。 这项建议在许多方面都是重要和独特的。首先，我们有强大的基线数据；我们在2000年和2001年测量了北卡罗来纳州(NC)幼儿的AHT率，当时该州和全国各地的医院还没有开始明确的预防工作。第二，我们有来自NC调查的行为数据，该调查引发了关于年幼孩子的父母颤抖的匿名自我报告。第三，我们正在与制定干预措施的研究团队合作，并对3000多名父母进行了干预的随机试验，以评估知识和态度的变化。发育儿科医生罗恩·巴尔 在不列颠哥伦比亚大学，摇晃婴儿综合症国家中心主任Marilyn Barr女士及其同事精心设计了干预措施以及视频和印刷材料。华盛顿大学的巴尔博士、巴尔女士和弗雷德·里瓦拉博士为这项申请提供了初步数据。第四，一个州领导委员会正在指导我们的干预行动，该委员会代表了北卡罗来纳州关心儿童福祉的广泛部门。这个组织已经计划了一年的全州范围的AHT预防计划。他们提供技术专长和实物支持。第五，我们已经与两个基金会--多丽丝·杜克慈善基金会和杜克基金会--合作，提供帮助 支持全州范围内的倡议，这一干预比NCIPC资金本身所允许的更雄心勃勃。他们的筹资决定悬而未决，他们的工作人员令人鼓舞(见支持函)。 我们的建议之所以重要，是因为有证据表明，摇晃是婴儿死亡的常见原因和主要原因。在北卡罗来纳州和南卡罗来纳州，2.6%的2岁以下儿童的父母报告说他们曾因为孩子的“纪律”而动摇过他(Theodore，et al.2005)。其他数据证实，虐待性头部创伤(AHT)的高危时期发生在生命的第一年(第一年为29.7/100,000活产，第二年为3.8/100,000儿童(Keenan等人，2003年)。婴儿(2-4个月大)患AHT的最高风险期与正常婴儿每天哭5小时以上的时期一致(Keenan等人)。2003年；阿格伦等人。2003年； Barr等人的研究成果。2006)。最后，该提案在检查整个州的实施、影响和估计成本与收益之间的关系方面具有重要意义。我们建议与北卡罗来纳州(约125,000名新生儿/年)的每一位新生儿的父母进行接触，并教育他和她关于婴儿哭泣的模式、对哭泣的反应以及摇晃的危险。每一位家长都将接受特定的干预，这是一个名为“紫色哭泣时期”的项目。该项目包括以医院和医疗保健提供者为基础的家长教育，以及一段10分钟的视频和一本精心设计的11页小册子，带回家与新的伴侣或儿童保育提供者分享如何应对哭泣。在Dias等人发表之后，许多州和医院已经开始采取摇晃婴儿综合征(SBS)的预防努力。(2005)。16个州[CA、FL、IL、IN、MA、MN、MO、NE、NY、PA、RI、TN、TX、VA、WA、WI]立法要求医院提供某种形式的SBS教育(书面材料或 视频)覆盖了2395,813名新生儿--占美国新生儿总数的58%。另外四个即将立法的州将把这一比例提高到出生的比例(乔治·利特科，个人沟通)。不再可能进行随机临床试验。我们提出了一个中断的时间序列设计、一个过程评估和一个病例对照研究，研究对象是尽管这项计划的努力，但仍有AHT经历的儿童。此外，我们还将检查项目成本，以评估我们方法的经济效益。 这项研究的具体目标是：1)与由儿童和家庭健康中心-NC和NC儿童伙伴关系领导的公共卫生、儿童护理、卫生保健、儿童倡导组织和军事卫生服务联盟合作，评估向该州每一名新生儿的父母提供特定的AHT预防计划-紫哭期-的情况。研究问题：a)北卡罗来纳州所有妇产科医院在4年内保持对计划交付方法的忠诚度的成功情况是什么？ 2)在项目实施后，对新父母进行电话调查，以确定他们对紫色干预和媒体宣传活动的接触，他们对这些信息的回忆和理解，他们在紫色哭泣期间自我报告的照顾孩子的行为，以及他们向其他照顾者传播紫色材料和信息的情况。

DESCRIPTION (provided by applicant): We propose to test whether a statewide primary preventive intervention, preparing parents of newborns to deal safely and explicitly with infant crying, can reduce hospital admissions and deaths from abusive head trauma (AHT). We plan to both educate parents and facilitate a cultural change in understanding the nature of, and appropriate responses to, infant crying. We will examine mediators and moderators affecting this intervention, conduct process evaluation, and assess the program's effectiveness and cost. This proposal is important and unique in a number of ways. One, we have strong baseline data; we measured the rates of AHT among young children in North Carolina (NC) in 2000 and 2001, before hospitals around the state and country began explicit prevention efforts. Two, we have behavioral data from a NC survey that elicited anonymous self-reports of shaking by parents of young children. Three we are collaborating with the research team that developed the intervention and has conducted a randomized trial of the intervention of over 3000 parents to assess changes in knowledge and attitudes. Dr. Ron Barr, a developmental pediatrician at the University of British Colombia and Ms. Marilyn Barr, Director of the National Center on Shaken Baby Syndrome and their colleagues carefully designed the intervention and the video and print materials. Dr. Barr, Ms. Barr and Dr. Fred Rivara at the University of Washington have provided preliminary data, for this application. Four, a state Leadership Committee that is representative of a broad cross-section of agencies concerned with child well being in NC is guiding our intervention. This group has been planning a statewide AHT prevention program for a year. They offer technical expertise and in-kind support. Five, we have already engaged with two foundations, the Doris Duke Charitable Foundation and the Duke Endowment, to help support the statewide initiative, an intervention more ambitious than NCIPC funding alone would permit. Their funding decisions are pending and their staff are encouraging (see letters of support). Our proposal's importance derives from evidence that shaking is both common and a leading cause of infant mortality. In North and South Carolina, 2.6% of the parents of children less than 2 report having shaken a child for "discipline" (Theodore, et al. 2005). Other data confirm that the highest risk period for abusive head trauma (AHT) occurs in the first year of life (29.7/100,000 live births in year 1 and 3.8/1000,000 children in year 2 (Keenan, et al., 2003). The highest risk period for AHT in infants (2-4 months of age) coincides with the period in which crying in normal infants can last over 5 hours per day (Keenan, et al. 2003; Agran et al. 2003; Barr, et al. 2006). Finally, the proposal is significant in examining implementation, impact, and estimated costs relative to benefits for an entire state. We propose to reach every parent of a newborn in NC (~125,000 births/ year) and educate him and her about infant crying patterns, responding to crying, and the hazards of shaking. Every parent will receive a specific intervention, a program called "The Period of PURPLE Crying." The program includes hospital and health care provider-based parent education, and a 10-minute video and a carefully designed 11-page booklet to take home and share with new partners or childcare providers about responding to crying. The adoption of shaken baby syndrome (SBS) prevention efforts have begun in many states and hospitals following the publication by Dias, et al. (2005). Sixteen states [CA, FL, IL, IN, MA, MN, MO, NE, NY, PA, RI, TN, TX, VA, WA, WI] have legislation requiring hospitals to provide some form of SBS education (written materials or video) cover 2,395,813 births - 58% of all US births. The four additional states with pending legislation will bring this to 64% of births (George Lithco, personal communication). It is no longer possible to develop a randomized clinical trial. We propose an interrupted time-series design, a process evaluation, and a case-control study of children who still experience AHT despite the efforts of this program. In addition, we will examine program costs to estimate the economic benefits of our approach. The specific aims of this study are: 1) Collaborate with a consortium in public health, child care, health care, child advocacy organizations, and military health services, led by the Center for Child and Family Health-NC and the NC Partnership for Children, to evaluate the delivery of a specific AHT prevention program, The Period of PURPLE Crying, to the parents of every newborn baby in the state. Research questions: A) What is the success in maintaining fidelity to the program delivery approach in all North Carolina maternity care hospitals over 4 years? B) What are the obstacles to delivering the program, with fidelity, to every mother of a newborn?; 2) Conduct, after program implementation, a telephone survey of new parents to ascertain their exposure to the PURPLE intervention and the media campaign, their recollection and understanding of the messages, their self-reported behaviors about caring for their child during The Period of PURPLE Crying, and their dissemination of PURPLE materials and messages to other caregivers.