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

描述（由申请人提供）：我们建议测试是否全州范围内的初级预防干预，准备新生儿的父母安全和明确地处理婴儿哭泣，可以减少住院和虐待性头部创伤（AHT）的死亡。 我们计划教育父母，并促进文化变革，了解婴儿哭泣的性质和适当的反应。 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。 第一，我们有很强的基线数据;我们测量了2000年和2001年北卡罗来纳州（NC）幼儿中AHT的发病率，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，该调查引发了幼儿父母的匿名自我报告。 第三，我们正在与开发干预措施的研究小组合作，并对3000多名父母进行了一项随机干预试验，以评估知识和态度的变化。 罗恩巴尔博士，一位发育儿科医生 英属哥伦比亚大学的Marilyn Barr女士和国家摇晃婴儿综合症中心主任Marilyn巴尔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该应用提供了初步数据。 第四，一个州领导委员会代表了北卡罗来纳州与儿童福祉有关的广泛的跨部门机构，正在指导我们的干预行动。 这个小组已经计划了一年的全州AHT预防计划。 它们提供技术专长和实物支助。 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捐赠基金会合作， 支持全州范围内的倡议，一个比NCIPC资金更雄心勃勃的干预将允许。 它们的供资决定尚未作出，其工作人员令人鼓舞（见支持信）。 我们的建议的重要性来自于有证据表明摇晃是婴儿死亡的常见和主要原因。 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，他们曾为了“纪律”而摇晃孩子（西奥多等人，2005年）。其他数据证实，虐待性头部创伤（AHT）的最高风险期发生在生命的第一年（第一年为29.7/100，000活产，第二年为3.8/1000，000儿童）（Keenan等人，2003年）。 婴儿（2-4月龄）中AHT的最高风险期与正常婴儿每天哭闹超过5小时的时期一致（Keenan等人，2003; Agran等人，2003; 巴尔等人，2006年）。 最后，该提案在审查整个州的实施、影响和相对于效益的估计成本方面具有重要意义。 我们建议接触NC的每一位新生儿父母（约125，000出生/年），并教育他和她有关婴儿哭泣模式，对哭泣的反应以及摇晃的危害。 每位家长都将接受一个特定的干预，一个名为“紫色哭泣期”的项目。“该计划包括以医院和医疗保健提供者为基础的家长教育，以及一个10分钟的视频和一本精心设计的11页小册子，带回家与新的合作伙伴或儿童保育提供者分享如何应对哭泣。 在Dias等人（2005年）出版之后，许多州和医院开始采用摇晃婴儿综合征（SBS）预防措施。 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2，395，813例出生-占美国出生总数的58%。 另外四个州的立法将使这一比例达到64%（乔治·利斯科，个人交流）。 现在已经不可能进行随机临床试验了。 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的儿童谁仍然经历AHT，尽管这个计划的努力。 此外，我们将检查计划成本，以估计我们的方法的经济效益。 本研究的具体目的是：1）与公共卫生，儿童保健，卫生保健，儿童倡导组织和军事卫生服务的财团合作，由儿童和家庭健康中心-NC和NC儿童伙伴关系领导，评估提供特定的AHT预防计划，紫色哭泣的时期，在该州每个新生儿的父母。 研究问题：A）在所有北卡罗来纳州的妇产医院中，4年来在保持对计划交付方法的忠诚方面取得了什么成功？ B）向每一位新生儿母亲忠实地提供该计划的障碍是什么？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活动的接触，他们对信息的回忆和理解，他们在紫色哭泣期间照顾孩子的自我报告行为，以及他们向其他照顾者传播紫色材料和信息。

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.