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.

National Institute of Health (NIH)
National Center for Injury Prevention and Control (NCIPC)
Coop: Injury Control Res. and Demo and Injury Prevention (U49)
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Special Emphasis Panel (ZCE1-JXS (04))
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University of North Carolina Chapel Hill
Schools of Medicine
Chapel Hill
United States
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Nocera, Maryalice; Shanahan, Meghan; Murphy, Robert A et al. (2016) A statewide nurse training program for a hospital based infant abusive head trauma prevention program. Nurse Educ Pract 16:e1-6
Dixon, Rebecca R; Nocera, Maryalice; Zolotor, Adam J et al. (2016) Intracranial Pressure Monitoring in Infants and Young Children With Traumatic Brain Injury. Pediatr Crit Care Med 17:1064-1072
Zolotor, Adam J; Runyan, Desmond K; Shanahan, Meghan et al. (2015) Effectiveness of a Statewide Abusive Head Trauma Prevention Program in North Carolina. JAMA Pediatr 169:1126-31
Shanahan, Meghan E; Zolotor, Adam J; Parrish, Jared W et al. (2013) National, regional, and state abusive head trauma: application of the CDC algorithm. Pediatrics 132:e1546-53