The program is unique among shaken baby syndrome efforts in several important ways:

• It approaches prevention through child development education about normal infant development, specifically, about crying in normal infants, rather than being limited to warnings of the negative consequences of shaking;
• It is based on over 30 years of research on normal infant crying conducted by Ronald G. Barr, MDCM and other scientists;
• It is based on strong scientific evidence about infant crying. Importantly, there is new evidence to demonstrate that infant crying is the most important stimulus for SBS;
• It aims to bring about a cultural change in our understanding of infant crying in caregivers and the community generally;
• It is a positive program that gives all parents encouragement that aims to improve their relationship with their baby;
• It uses highly attractive, positive messages for parents rather than negative warnings about detrimental consequences; and
• It is designed to increase penetration rate (get the program to more parents and caregivers) as it is likely to be more widely acceptable to health care professionals and groups disseminating the intervention.

The program was tested over a three year period. In the first year the new materials, a DVD, and an 11-page booklet were revised through testing with 19 parent focus groups in the United States and Canada. The focus groups included 16 groups for mothers, 2 for fathers, and 1 for Native Americans/First Nations. The groups were multicultural and had various socioeconomic backgrounds. The materials were also reviewed by 35 highly regarded clinical pediatric and academic research physicians, public education consultants and public health nurses.

The program was then rigorously tested in two parallel randomized controlled trials in Seattle, Washington (USA) and in Vancouver, British Columbia (Canada). The large scale trails included 4,400 parents and assessed their ability to change knowledge and behavior of mothers related to the information provided in the educational materials.

The settings where the program was delivered included: (1) prenatal classes; (2) maternity wards; (3) pediatric practices; and (4) home visits by public health nurses.

The studies were completed in early 2007 and it took several months to assess the data. We feel the data are encouraging and that is one reason the program is now available. Both studies found that there was a statically significant increase in the knowledge about normal infant crying and understanding the dangers of shaking an infant. The findings also showed that there was a statistically significant difference in parental behavior in that they were more likely to share information with others.

Seattle, Washington Trial in Pediatrics

The following article describing the randomized controlled trial of the Period of PURPLE Crying® materials in Seattle, Washington has been published in the March issue of Pediatrics.

Article Title: Effectiveness of educational materials designed to change knowledge and behaviors regarding crying and shaken baby syndrome in mothers of newborn infants: a randomized controlled trial.

Authors and Investigators: Barr RG, Rivara FP, Barr M, Cummings P, Taylor J, Lengua LJ, Meredith-Benitz E.

Vancouver, British Columbia, Canada Trial in the Canadian Medical Association Journal

The following article describing the randomized controlled trial of the Period of PURPLE Crying® materials in Vancouver, British Columbia, Canada has been published in the March edition of the Canadian Medical Association Journal.

Article Title: Do educational materials change knowledge and behaviors regarding crying and shaken baby syndrome in mothers of newborns when delivered by public health home visitor nurses? A randomized controlled trial.

Authors and Investigators: Ronald G. Barr, MDCM, FRCPC, Marilyn Barr, BIS, SSW, Takeo Fujiwara, MD, PhD, MPH, Jocelyn Conway, BA, Nicole Catherine, M. Sc., Rollin Brant, PhD.

Click here to read the full article on the CMAJ website.

The program components were designed to overcome recognized barriers to delivering such educational information to parents that occur with other prevention materials by ensuring that the materials are:

• Educational and attractive to parents of newborns on the first day of life
• Interesting and valuable for all parents because of the information about infant crying, whether or not they would ever consider shaking their baby
• Clear, memorable, and meaningful with a positive message
• Presented at a grade three language level
• Inclusive of many cultural and ethnic backgrounds
• Acceptable to public health nurses: no bottles, blankets, or bumper pads
• Economical
• Designed for each family of a new baby to receive a copy to review and to share with others

The published article by Dr. Mark Dias describes a “process” model or “steps of how to deliver” an SBS prevention program. The PURPLE program is the “content.” These two can be combined for a very effective program. Dr. Dias is very clear that his model refers to the “process” not the “content.” The Dias published model is an “open source” model without regard to the materials that are delivered.

The PURPLE program materials have gone through more extensive testing than any other SBS prevention program in North America. It has been developed through the use of 25 parent focus groups as of the date of writing, and more are being added. They have been run by independent professional focus group leaders over three years and in two countries. In addition, The Period of PURPLE Crying® program materials are the only SBS prevention materials that have ever undergone randomized controlled trials, the gold standard of research. These randomized controlled trials included about 4,400 participants, also in two countries. There are no other SBS prevention materials available that have been more rigorously tested or so closely based on empirical findings.

The program that was tested to be effective in changing knowledge and behaviors in mothers included the 10-minute DVD and the 11-page full color booklet. The tested model is that every family of a new baby receives this set of materials to take home with them. There are four very good reasons families must each have their own copy:

• The Period of PURPLE Crying® starts at about 2 weeks, peaks at about two-months, and usually comes to an end by about 4-5 months, and often earlier. It is very important that parents have the materials with them, at home, and when their baby goes through The Period of PURPLE Crying®.
• It is vital that other people who care for the baby, including relatives, friends, boyfriends, also look at the DVD and read the booklet. The parent must have these materials to show to them and to educate others.
• Even intelligent parents do not learn things only by hearing or watching the information one time. They must also be willing to “receive/hear” the message when it is relevant to them. Parents and other caretakers must be exposed to it as many times as is necessary to understand the message and change their beliefs and behavior.
• When parents experience having a baby that cries a lot, even for one day, they need something immediately that can give them accurate and supportive advice so they do not get so frustrated with the baby. They need permission to put the baby down in a safe place and walk away for awhile and take some time to calm down when they become frustrated.

The aim of the program is to bring about a cultural change in attitudes and behavior about normal infant crying in parents and in society generally. The PURPLE program is designed to educate parents and others about the normal properties of early infant crying, and to reduce the stress and frustration parents experience when they have a baby who cries. In this aim, it is similar to the “Back to Sleep” campaign for the reduction of sudden infant death syndrome (SIDS). This approach brought about a cultural change in the way we put babies to sleep. The PURPLE program has been designed to change the way we understand early increased infant crying so that parents and caregivers will have reasonable expectations for their baby and for themselves as caregivers.

Since the program is designed to bring about a cultural change in attitudes and beliefs about infant crying, we recommend the following triple dose approach.

PURPLE Program Model: Triple Dose Approach with Enhancements and Reinforcements

Dose One: Maternity Wards
The PURPLE program is given to families of new babies, both mothers and fathers, in the hospital after the birth of their baby. Maternity nurses are trained and provided with a script to use when presenting the materials to families of new babies and the PURPLE Crying materials themselves. Each family receives the 10-minute DVD and 11-page booklet about PURPLE Crying to take home with them. The DVD and booklet cannot be distributed as separate components. Parents must receive both the DVD and booklet together as one package. When possible, the parents should watch the film in the hospital and be able to ask the nurse questions. It is very important that the parents receive the program from a person in a position of authority or influence, like a maternity nurse or health educator. It is equally important that the person delivering the PURPLE program recommends its use to the parents, encourages them to review the materials, and recommends sharing the materials with other caregivers of their baby.

Dose Two: Pre- and Postnatal Primary Health Care Units or Public Health Visiting Nurses
Public heath nurse home visitors, pediatricians, family doctors or public health clinics can reinforce the message by talking to parents about the concepts taught in the Period of PURPLE Crying® program. If needed, the physician (or office personnel) can provide materials to parents who were missed at the hospital after having their baby and did not receive the PURPLE materials. It is important not to duplicate the materials in the distribution process as, ideally; most parents should have received the materials at the hospital.

Dose Three: Public Education and Media Campaign
A public education campaign provides this information to everyone, including all those who did not receive the program through the previous two methods. This is an important part of bringing about a cultural change as it is necessary to educate grandmothers, boyfriends, neighbors and relatives about the PURPLE program. Understanding of the Period of PURPLE Crying® among the general population can help ease the stresses of parents dealing with the inconsolable crying of their babies. Mothers and fathers are more likely to receive support and reinforcement from those who understand the Period of PURPLE Crying® concept.

Reinforcement and Enhancements
Other groups who serve parents are specifically targeted to facilitate complete community coverage about the Period of PURPLE Crying® program. Childcare providers, foster care workers, midwives, advice and hot line personnel, family practice physicians, emergency room personnel and other groups serving parents should be contacted and receive training on the Period of PURPLE Crying®. This ensures that parents get the same information wherever they go for help and advice.

Yes, it is recommended that hospitals who invest in the program model provide at a minimum a 5-minute presentation at the bedside or in a discharge class about the Period of PURPLE Crying®, show the DVD and answer any questions about the Period of PURPLE Crying®. Scripts are provided for the presentation.

However, each family must receive their own copy to take with them as this is the tested model. The program is also designed to be presented at pre-natal programs, discharge classes, child care classes, health departments, and other places where families are served. These sources of information serve as “enhancements” or “reinforcements” of the program. Scripts will be available for these setting as well so that the message remains consistent and correct.

Please Note: For the year 2008, in the state of North Carolina or the province of British Columbia the cost of the state-wide or province-wide hospital based program is supported by grants.

The tested model is that each family of a new baby receives a set of the materials to take home. The materials include a 10-minute DVD and a full color 11-page booklet. The cost is as little as $2 each depending upon the quantity ordered. The breakdown of pricing for PURPLE is as follows:

• 100-499: $3.50 per package
• 500-999: $2.50 per package
• 1,000+: $2.00 per package

The PURPLE program is sold in increments of 100 and up.
For orders of 10,000 or more, and for a minimal additional cost, an insert page (5.25” X 7”) can be added to the inside of the DVD case. This can include information like local contact numbers, program sponsors and other information.

No, they are not. The previously developed PURPLE brochures and posters are no longer available as they have been replaced by the new empirically-tested program.

The NCSBS is developing additional materials to be used as enhancements or to reinforce the message. Some items include a: poster, certificate, reminder post card, and diaper bag tag.

In addition, public education materials are being developed for use in media and other education campaigns.

The program materials have been translated into Spanish, Cantonese, Punjabi, Korean, Vietnamese, Portuguese, French, and Japanese, and are close captioned for the hearing impaired on the English version. Orders for languages other than English and Spanish can be taken and produced; however if the order is a small order, individual costs may be higher.

The translation process has been completed with the most sophisticated process possible. These are not subtitles, but overlay talking in the film. Please click here for more information on the translation process.