Program Profile: Period of PURPLE Crying

This is a preventative approach that uses educational materials to inform caregivers about the frustration caused by an infant’s prolonged crying and about behaviors that reduce the risk of shaking and abuse. The program is rated Ineffective. There were no statistically significant differences between the intervention and comparison groups on measures of crying generally, unsoothable crying, and caregiver self-talk.

An Ineffective rating implies that implementing the program is unlikely to result in the intended outcome(s).

This program's rating is based on evidence that includes at least one high-quality randomized controlled trial.

This program's rating is based on evidence that includes either 1) one study conducted in multiple sites; or 2) two or three studies, each conducted at a different site. Learn about how we make the multisite determination.

Program Goals/Target Population

The Period of PURPLE Crying is a preventive approach that uses educational materials to inform caregivers about the frustration caused by an infant’s prolonged crying and about behaviors that reduce the risk of shaking and abuse. The program materials address the association between infants’ inconsolable crying and shaken baby syndrome. Prolonged bouts of inconsolable crying clustered in the evening for the first few months after birth, which persist despite all efforts to soothe the infant, are a natural source of frustration and even anger for parents. Even parents who understand the harmful effects of shaking a baby may feel the urge to shake the infant if they do not already have alternative strategies in place. The program seeks to educate expectant or very new parents to expect this typical phase of their new infant’s life and provides them with educational materials on the dangers of shaking, strategies for avoiding shaking their infants, and the importance of sharing this knowledge with the infant’s other caregivers. The overall goal is to prevent parents from shaking their crying babies in frustration.

The program has been delivered in the United States, Canada, and Japan. In Japan, the materials were transcribed based on focus groups held with mothers who spoke both English and Japanese and mothers who spoke Japanese only.

Program Components

Because shaken baby syndrome can occur by the time an infant is 2 weeks old, the program aims to provide information to parents before or soon after birth. Materials include an 11-page booklet and a DVD about infant safety. The materials describe the PURPLE period during which a healthy infant’s crying could frustrate caregivers. This includes 1) peak of crying, during which crying increases after 2 weeks, increases and peaks in the second month, and then declines; 2) unexpected timing of prolonged crying bouts; 3) resistance to soothing; 4) pain-like face; 5) long-lasting bouts of crying; and 6) evening, which refers to late afternoon and evening clustering.

The materials are designed to show that inconsolable crying is normal infant behavior, suggest ways to soothe infants, emphasize that soothing will not always work, describe why inconsolable crying is frustrating to parents and other caregivers, and suggest three guidelines to use while caring for a crying infant. First, the materials encourage parents to use typical calming responses (such as carry, comfort, walk, and talk) with their infants. If the crying is too frustrating, they are next encouraged to put the baby down in a safe place, walk away, calm themselves down, and then return to check on the baby. Finally, the materials stress that they must never shake a baby. The parents are also encouraged to share this information with all the infant’s other caregivers.

Program Theory

Period of PURPLE Crying is based on the idea that parents and other caregivers will not shake a baby if they understand the dangers and know of alternative strategies. The program provides parents with the knowledge that there may be a period of several months, beginning around 2 weeks of age, during which it is normal for infants to have prolonged, inconsolable, and unpredictable episodes of crying that cluster in the evening, but that after a few months, these periods will lessen or come to an end. However, because this period is very frustrating for parents and other caregivers, they are taught about how shaking a baby can inflict traumatic brain injury, with or without contact between the child’s head and a hard surface, and with serious health consequences for the child, including head trauma and death. Thus, it is important, even among parents and caregivers with this knowledge, to provide them with strategies that they can use when faced with the frustration of prolonged infant crying.

Study

Barr and colleagues (2009a) conducted a randomized controlled trial in Canada to evaluate the Period of PURPLE Crying on new mothers’ knowledge and behaviors in regard to shaken baby syndrome. Research assistants or discharge nurses recruited participants from hospitals in the Greater Vancouver area (British Columbia, Canada), between May 2005 and November 2006. Eligible mothers had an uneventful pregnancy, a healthy singleton infant (defined as greater than 37 weeks’ gestation), access to a DVD player, and were fluent in English. Period of PURPLE Crying materials included an 11-page booklet and a DVD, and materials for the comparison group included injury prevention materials consisting of two brochures and a DVD about infant safety. Both groups received a Baby’s Day Diary with instructions, a sealed envelope with the study materials, and a teddy bear.

A total of 1,833 mothers consented to participate and were randomly assigned to the treatment (n = 649) or comparison (n = 630) group. For 58 percent of the treatment group and 59 percent of the comparison group, the baby was their first child. In the treatment group, 10 percent of the mothers were younger than age 25, 59 percent were between ages 25 and 35, and 31 percent were older than age 35. In the comparison group, 7 percent of the mothers were younger than age 25, 64 percent were between ages 25 and 35, and 30 percent were older than age 35. There were no significant differences between groups at the baseline. No information was provided on race or ethnicity.

Five weeks after giving birth, mothers were telephoned and reminded to complete the diary. Three weeks later (i.e., 8 weeks after giving birth), an independent research group telephoned the mothers to administer a 20-minute questionnaire. All participants completed pre- and posttest measures. The outcomes measured included crying generally, unsoothable crying, and caregiver self-talk. The crying generally and unsoothable crying outcomes referred to how mothers responded to crying, whereas caregiver self-talk referred to how mothers reassured themselves when responding to the crying (such as telling themselves the crying will end, or the baby is okay). The researchers used the Response to Crying Generally Scale to measure the first outcome and the Responses to Unsoothable Crying Scale to measure the other two outcomes. Differences in mean scores for the treatment and comparison groups were computed for positive behavior used during crying (i.e., soothing, setting the baby down in a safe place, walking away), positive behavior used during inconsolable crying, and self-talk during inconsolable crying. Subgroup analyses were conducted.

Study

Barr and colleagues (2009b) conducted a randomized controlled trial in the United States to evaluate the effectiveness of the Period of PURPLE Crying intervention in increasing knowledge and changing behaviors related to crying and the dangers of shaking. Participants were recruited from prenatal classes (10 sites), maternity wards (3 hospitals) and pediatric offices (11 practices) in Washington State between December 9, 2004, and October 9, 2006. Participants were randomized into either the treatment group (n = 1,374) or the comparison group (n = 1,364). The intervention group received Period of PURPLE Crying materials, including an 11-page booklet and a DVD. Materials for the comparison group included injury prevention materials consisting of two brochures and a DVD about infant safety. Participants were mailed intervention or control materials, a diary with written instructions, a sample diary page, and a practice page. Five weeks following birth, mothers were telephoned and reminded to complete the diary. One day after beginning the diary, another call was made to answer questions about diary completion. Diaries were returned to the research assistants in self-addressed stamped envelopes. Two months after birth, mothers participated in telephone interviews delivered by a professional survey.

Fourteen percent of the intervention group were between ages 18 and 24, 62 percent were between ages 25 and 34, and 25 percent were older than age 35. Sixteen percent of the comparison group were between ages 18 and 24, 61 percent were between ages 25 and 34, and 23 percent were older than age 35. There were no statistically significant differences between groups at the baseline.

The intervention and comparison group participants completed pre- and posttest measures. The outcome measures included crying generally, unsoothable crying, and caregiver self-talk. The researchers used the Response to Crying Generally Scale and the Responses to Unsoothable Crying Scale. Mean differences for outcome scores between participants in the intervention and comparison groups were identified using 2-way t-tests. The researchers conducted subgroup analyses based on if the infant was the mother’s first child, mother’s educational attainment; recruitment site; intervention pamphlet read, video viewed, or both; and whether the infant demonstrated unsoothable crying.

Study

Fujiwara and colleagues (2012) used a randomized control design in Japan to evaluate the effectiveness of the Period of PURPLE Crying intervention. Participants were recruited from two hospitals within greater Tokyo, Japan. One hospital is in Kanagawa prefecture, south of Tokyo, and the other is in Saitama prefecture, north of Tokyo. Both prefectures are suburban, residential areas consisting primarily of middle-class families. Eligible mothers had an uneventful pregnancy, gave birth to a single baby after 37 weeks of gestation, and had access to a DVD player. The PURPLE group received educational materials, including an 11-page booklet and a DVD that described shaken baby syndrome, the dangers of shaking, and the action steps. Participants were instructed to complete diary entries every 2 to 3 hours to record common activities such as feeding, sleeping, and crying. The comparison group received an injury prevention DVD on infant safety. Japanese translation of the materials was based on two focus groups consisting of mothers who spoke both English and Japanese and mothers who spoke Japanese only.

A total of 201 women were enrolled in the study. The intervention group comprised 105 women. Of this group, 10 percent were younger than age 25, 58 percent were between ages 25 and 34, and 32 percent were older than age 35. Forty-six percent of the women were first-time mothers. The comparison group comprised 95 women. Twelve percent of the women were younger than age 25, 61 percent were between ages 25 and 34, and 27 percent were older than age 35. Forty-five percent of the women were first-time mothers. There were no significant differences between the intervention and comparison groups at baseline.

The intervention and comparison group participants completed pre- and posttest measures. The outcome measures included crying generally, unsoothable crying, and caregiver self-talk. The researchers used the Response to Crying Generally Scale to measure the first outcome and the Response to Unsoothable Crying Scale to measure the other two outcomes. Mean differences for outcome scores between participants in the intervention and comparison groups were identified using 2-way t-tests. The researchers conducted subgroup analyses based on the baby’s parity and the mother’s educational attainment.

Implementation information can be found at https://dontshake.org/purple-crying. The website provides a free online training for organizations that are preparing to deliver and reinforce the PURPLE program, answers to frequently asked questions for parents and professionals, and downloadable materials.

Subgroup Analysis

Subgroup analyses in the first two studies (Barr et al. 2009a; 2009b) were conducted by level of education, whether materials were read or viewed, whether the infant was the participant’s first child, and whether the infant demonstrated inconsolable crying. None of these results were statistically significant for the following three outcomes: 1) behavior for crying, 2) behavior for inconsolable crying, and 3) self-talk during inconsolable crying.

The third study (Fujiwara et al. 2012) found a statistically significant interaction effect between the intervention and first-time motherhood. Mothers who had more than one child scored significantly higher on crying knowledge and self-talk responses to unsoothable crying, whereas there was no increase in crying knowledge or in self-talk behavior for first-time mothers. There was not an overall significant interaction between the intervention and educational level; however, mothers in the intervention group who had completed high school or less, or had a college degree or more, scored significantly higher on crying knowledge than did comparison group mothers of the same educational attainment.

These sources were used in the development of the program profile: