Randomized Control Trials

 Sadler, K., Rajabali, F., Zheng, A., et al. (2023). Impact of a Parent Education Program Delivered by Nurses and Health Care Providers in Reducing Infant Physical Abuse Hospitalization Rates in British Columbia, Canada. Canadian Journal of Nursing Research, 56(1):109-116.

Fujiwara, T., Yamada, F., Okuyama, M., Kamimaki, I., Shikoro, N., & Barr, R. G. (2012). Effectiveness of educational materials designed to change knowledge and behavior about crying and shaken baby syndrome: A replication of a randomized controlled trial in Japan. Child Abuse & Neglect, 36(9), 613-620.

Barr, R. G., Barr, M., Fujiwara, T., Conway, J., Catherine, N., & Brant, R. (2009). Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. Canadian Medical Association Journal, 180(7), 727-733.

Barr, R. G., Rivara, F. P., Barr, M., Cummings, P., Taylor, J., Lengua, L. J., & Meredith-Benitz, E. (2009). Effectiveness of Educational Materials Designed to Change Knowledge and Behaviors Regarding Crying and Shaken-Baby Syndrome in Mothers of Newborns: A Randomized, Controlled Trial. Pediatrics, 123(3), 972-980.

Other Research with the Period of PURPLE Crying

Jalloul, R. J., Vigil, A., Chen, H. Y., & Ward, C. (2022). Effectiveness of Educational Materials Designed to Improve Knowledge Regarding Crying and Shaken Baby Syndrome in Mothers of Hispanic Population. Hispanic health care international, 20(3), 179-183.

Beaulieu, E., Rajabali, F., Zheng, A., & Pike, I. (2019) The lifetime costs of pediatric abusive head trauma and a cost-effectiveness analysis of the Period of Purple crying program in British Columbia, Canada Child Abuse & Neglect, 97(0145-2134), 104133.

Barr, R. G., Barr, M., Rajabali, F. et al. (2018). Eight-year outcome of implementation of abusive head trauma prevention. Child Abuse & Neglect, 84(0145-2134), 106-114.

Nocera, M., Shanahan, M., Murphy, R. A., Sullivan, K. M., Barr, M., Price, J., & Zolotor, A. (2016). A statewide nurse training program for a hospital based infant abusive head trauma prevention program. Nurse Education in Practice, 16(1), e1-e6.

Zolotor, A. J., Runyan, D. K., Shanahan, M., Durrance, C. P., Nocera, M., Sullivan, K., . . . Barr, R. G. (2015). Effectiveness of a Statewide Abusive Head Trauma Prevention Program in North Carolina. JAMA Pediatrics, 169(12), 1126-1131.

Barr, R. G., Rajabali, F., Aragon, M., Colbourne, M., & Brant, R. (2015). Education About Crying in Normal Infants Is Associated with a Reduction in Pediatric Emergency Room Visits for Crying Complaints. Journal of Developmental & Behavioral Pediatrics, 36(4), 252-257.

Stewart, T. C., Gilliland, J., Parry, N. G., & Fraser, D. D. (2015). An evidence-based method for targeting an abusive head trauma prevention media campaign and its evaluation. Journal of Trauma and Acute Care Surgery, 79(5), 748-755.

Reese, L. S., Heiden, E. O., Kim, K. Q., & Yang, J. (2014). Evaluation of Period of PURPLE Crying, an abusive head trauma prevention program. Journal of obstetric, gynecologic, and neonatal nursing, 43(6)752-761. 

Barr, R. G., Fairbrother, N., Pauwels, J., Green, J., Chen, M., & Brant, R. (2014). Maternal frustration, emotional and behavioural responses to prolonged infant crying. Infant Behavior and Development, 37(4), 652-664.

Barr, R. G. (2012). Preventing abusive head trauma resulting from a failure of normal interaction between infants and their caregivers. Proceedings of the National Academy of Sciences, 109(Supplement_2), 17294-17301.

Stewart, T. C., Polgar, D., Gilliland, J., Tanner, D. A., Girotti, M. J., Parry, N., & Fraser, D. D. (2011). Shaken Baby Syndrome and a Triple-Dose Strategy for Its Prevention. The Journal of Trauma: Injury, Infection, and Critical Care, 71(6), 1801-1807.

Shanahan, M. E., Nocera, M., Zolotor, A. J., Sellers, C. J., & Runyan, D. K. (2011). Education on Abusive Head Trauma in North Carolina Hospitals. Child Abuse Review, 20(4), 290-297.

Stewart, T. C., Polgar, D., Gilliland, J., Tanner, D. A., Girotti, M. J., Parry, N., & Fraser, D. D. (2011). Shaken Baby Syndrome and a Triple-Dose Strategy for Its Prevention. The Journal of Trauma: Injury, Infection, and Critical Care, 71(6), 1801-1807.

Zolotor, A. (2010). Preventing Child Maltreatment in North Carolina. North Carolina Medical Journal, 71(6), 553-555.

Runyan, D. K., Hennink-Kaminski, H. J., Zolotor, A. J., Barr, R. G., Murphy, R. A., Barr, M., . . . Nocera, M. (2009). Designing and Testing a Shaken Baby Syndrome Prevention Program – The Period of PURPLE Crying: Keeping Babies Safe in North Carolina. Social Marketing Quarterly, 15(4), 2-24.

Hennink-Kaminski, H. J., & Dougall, E. K. (2009). Tailoring Hospital Education Materials for The Period of PURPLE Crying: Keeping Babies Safe in North Carolina Media Campaign. Social Marketing Quarterly, 15(4), 49-64.

Hennink-Kaminski, H. J., & Dougall, E. K. (2009). Myths, Mysteries, and Monsters: When Shaken Babies Make the News. Social Marketing Quarterly, 15(4), 25-48.

Parent Focus Groups

Focus Groups on Period of PURPLE Crying© Program PURPLE Video and Booklet Material:
In 2004, Dan Jones and Associates of Salt Lake City, Utah, USA were hired to conduct the United States Parent Focus Groups on the PURPLE materials. The primary purpose was to obtain in-depth understanding about attitudes regarding infant crying, what people know about SBS, and how new parents cope with incessant crying by their infants.

A total of six focus group sessions were conducted on September 28 - 29, 2004. Prospective participants were screened to ensure that they had infants six months old or younger. A total of 63 people participated in the research: 42 new moms and 21 new dads. Males and females were separated by groups and represented a broad range of socio-economical and geographical areas within the Salt Lake City, Utah metropolitan area.

Canadian Parent Focus Groups: Prevent SBS British Columbia also coordinated the evaluation of the PURPLE educational materials from the National Center on Shaken Baby syndrome for their suitability to the Canadian culture in 2004. Samsara Communications was hired to facilitate the focus group presentations, to train project personnel to appropriately handle the comments from participants, and to elicit feedback from participants. MTM Research was hired to analyze the results and report the key findings.

In order to meet the objectives, 8 focus group sessions were conducted between June 1st and November 16th, 2004 throughout the Vancouver, Vancouver Island and Fraser Valley Health regions. These areas included Chilliwack, Duncan, Port Moody, Richmond, Surrey, and Vancouver. A total of 66 parents (59 mothers, 6 fathers, and 1 elder) representing various backgrounds of race, economic status and family makeup participated. Participants were biological or adoptive parents of infants <6 months old (excluding the elder) and were proficient in spoken and written English.

Focus Groups on the Period of PURPLE Crying Program’s Crying, Soothing and Coping: Doing What Comes Naturally Video:
In 2011, three focus groups were conducted to gather feedback on the feelings and perceptions of the narrations and content for the newly developed supplemental film on soothing and coping strategies called Crying, Soothing and Coping: Doing What Comes Naturally. The focus groups were held in Chicago, Salt Lake City and Atlanta. The focus groups in Chicago and Atlanta were conducted by Beall Research and Training. In Chicago, the focus group consisted of 12 fathers with children under two years of age. The age of participants ranged from 23 to 47. In Atlanta, the focus group consisted of 12 mothers with children under two years of age. The age of participants ranged from 18 to 39. Dan Jones and Associates conducted the Salt Lake City focus group that consisted of 9 mothers with children under the age of two. All focus groups were made up of individuals with diverse social, socio-economic, nationality and educational backgrounds.

The feedback from these three focus groups allowed the NCSBS to refine the content and narration to ensure the film was acceptable and helpful to a wide range of parents and caregivers. A full report on the focus groups conducted for the Crying, Soothing and Coping film is available from the NCSBS upon request.

Focus Groups on Period of PURPLE Crying Program Translations:
Translation Focus Group Testing: Prevent SBS British Columbia and the NCSBS staff have coordinated focus groups in the process of translating the PURPLE materials into several languages. The goal of the translation project for the Period of PURPLE Crying is to receive a culturally sensitive, accurately translated product that keeps the clarity and cohesiveness of the message.

There were additional measures added to ensure our specific translation project received the highest quality product. First, an initial focus group made up of five qualified and working healthcare interpreters analyzed the materials in order to provide suggestions to the translator in difficult areas. Secondly, once the unilingual parent focus group had viewed the product in the subject language and adjustments were made, an English back translation was requested from a separate translator with no previous knowledge of the product.

Translation focus groups will continue to occur with each new language chosen. As of June 23, 2016, the program has been translated into the following languages: Cantonese, Punjabi, Spanish (Mexican-dialect), Korean, Vietnamese, Japanese, French, Portuguese (Brazilian Dialect), Somali and Arabic. Through the process it has become very apparent that the program messages are relevant to all parents, of all kinds of families in all the cultures included in this process. It was a very rewarding process to know the program was valued by so many.

What is Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

The American Academy of Pediatrics describes Shaken Baby Syndrome as: a term often used by physicians and the public to describe abusive head trauma inflicted on infants and young children. Although shaking an infant has the potential to cause neurologic injury, blunt impact or a combination of shaking and blunt impact cause injury as well.

What happens to the brain during a shaking event?

An infant’s brain has a higher water content and less myelination than an adult brain and is more gelatinous and is easily compressed and distorted within the skull during a shaking episode. When shaken, the brain rotates relative to a more stationary skull, creating rotational and angular forces of the head. The lag time between the movement of the skull and the brain creates stress and tearing of blood vessels. The vessel injury leads to brain bleeding, or subdural hemorrhages.

What are subdural hemorrhages?

A subdural hematoma, or hemorrhage, is usually caused by a head injury strong enough to burst blood vessels. This can cause pooled blood to push on the brain. Trauma to the head tears blood vessels that run along the surface of the brain.

How much force is necessary to cause injuries in Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)? How many times do you have to shake an infant or young child to cause damage?

The injuries seen in cases of SBS/AHT are caused by violent shaking and, in some cases, impact. This is due to the rapid and repeated acceleration and deceleration of the victim’s head whipping back and forth and side to side. Shaking injuries are not caused by casual or accidental handling of children. Shaking injuries require massive, violent force. One shake is all it takes to cause traumatic brain injuries in an infant.

What is the retina of the eye?

The retina is a light-sensitive layer at the back of the eye that covers about 65 percent of its interior surface. Photosensitive cells calls rods and cones in the retina convert light energy into signals that are carried to the brain by the optic nerve. In the simplest terms, the retina is the lining of the inside of the eyes.

What happens to the eyes during a shaking event?

The same kind of violent motion that happens in the brain during shaking also occurs in the eye. When a child is violently shaken, the eyeball and its contents move back and forth in many different directions within the eye socket. The forces produced during a shaking episode may cause the layers of the retina to slide across each other creating stretching and shearing of the retinal vessels resulting in hemorrhages.

What are retinal hemorrhages and what is their relationship to Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

Bleeding in the layers of the retina are called retinal hemorrhages. Retinal hemorrhages, especially those at the ora serrata and those involving many layers of the retina are frequently seen in SBS/AHT victims and are uncommon in other types of head injury. Retina hemorrhages typically happen in both eyes (bilateral) but can also be unilateral (one eye). This type of bleeding can only be viewed by a doctor using specialized equipment.

What other types of injuries might occur as a result of shaking?

Other injuries that can occur as a result of shaking are cerebral edema (brain swelling), cerebral contusions (brain bruises), external head bruises, body bruises, skull fractures, rib fractures, long bone fractures, neck and spinal cord damage, or other injuries that cannot be explained through a medical condition or accidental trauma.

Do falls cause injuries similar to Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

Accidental falls, even down stairways, are not generally the cause of brain injuries in infants. Household falls from furniture or down stairs most commonly result in minor trauma. High-velocity impact injuries, falls from extreme heights, or falls onto extremely hard surfaces provide the opportunities for more severe injuries, like those seen in SBS/AHT injuries.

Predisposing factors in Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

Common factors associated with increased risk of child abuse are often individual characteristics, substance abuse, and young age of the parent or caregivers; the age, health, physical, mental, emotional, and social development of the child; history of violence within the family structure; poverty and economic conditions, social attitudes, promotion of violence, and cultural norms of the community; lack of education and resources for the family.

What are CT scans and MRIs and how are they used to diagnose Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

A CT (computed tomography) scan is an X-ray technique that produces a detailed cross-section of tissue structure. An MRI (magnetic resonance imaging) is medical imagining that gives pictures of organs and different structures of the body which gives different information about the body than can be seen with an X-ray, ultrasound, or CT scan.

A CT scan gives sufficient resolution and detail to allow a physician to evaluate an acute brain injury in an abused child. MRI scans are used several days to a week after an injury to better diagnose the types of injuries to the brain and show changes in in the brain tissue. Most skull fractures can be best shown with an X-ray.

How can the injuries be dated and the time of injuries be determined?

Clinical history, physiologic data, and imaging are the three (3) sources physicians use to establish the timing of head injuries.

What is the outcome or prognosis of victims of Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT)?

The outcomes for victims of SBS/AHT largely depend on the severity of the abuse. One third (1/3) of SBS/AHT victims who develop symptoms either do not have significant disabling conditions or the outcomes are less well-defined. Mild injuries might include learning disabilities, personality changes, or behavior problems. Other children have seizure disorders, developmental, or mental delays. Many children are left with blindness, profound reduced mental capacity, spastic diplegia (paralysis of both sides), or quadriplegia (all sides). Some children develop cerebral palsy or some continue to live in a persistent vegetative state.

How can Shaken Baby Syndrome/Abusive Head Trauma (AHT) be prevented?

Child abuse, and specifically SBS/AHT, is prevented through parent/caregiver education classes about normal infant crying patterns, increased general public awareness, respite care for overwhelmed parents/caretakers, parents having a plan of action for when they become upset or exhausted while taking care of an infant/child, a parent putting the infant/child down in a safe place and walking away until they regain composure, parents/caregivers asking for help from family members or friends, and having the infant/child evaluated by a doctor if there are concerns about the baby’s physical condition.