An interventional study of Education about infant crying in Child Abuse and Shaken Baby Syndrome, sponsored by Harborview Injury Prevention and Research Center. Status unknown at 1 site in United States. Open to participants aged 1 Day to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Harborview Injury Prevention and Research Center · Not applicable, Interventional, and Prevention
This research project seeks to implement an early intervention program that can be effective in the prevention of Shaken Baby Syndrome (SBS) and infant abuse. Our hypothesis is that the Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through changes in knowledge, attitudes and behaviors about early infant crying, especially inconsolable crying. In this 3-year project, we will implement and evaluate an intervention program in selected prenatal classes, hospitals, and primary care pediatric practices.
In this randomized, controlled trial, we will enroll a total of 3000 women/families who are about to give birth or have just given birth to a healthy infant. At each of the three sites (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects. Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp cloth) about infant crying. The other half, the control group, will receive comparable materials on infant safety. All subjects will be asked to complete a brief questionnaire at the time of enrollment (pre test), review the materials they receive, complete the Baby's Day Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire (post test) when the infant is 8 weeks of age.
The specific goals of the program are:
9,221 studies on the registry are indexed under Syndrome; 1,034 are open to participants now.
This study's enrollment of 3,000 is above the median of 50 across 6,517 interventional studies indexed under Syndrome.
Browse Syndrome studies →This is the only study on the registry with Harborview Injury Prevention and Research Center as lead sponsor.
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Exclusion Criteria:
Knowledge and attitudes about crying, shaking and abuse
Caregiver behavior
Parenting sense of competence
Maternal depression
This study is status unknown, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.
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Shaken Baby Syndrome