Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105963
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-03-18
Brief Title:
Prevention of Shaken Baby Syndrome
Sponsor:
Harborview Injury Prevention and Research Center
Organization:
Harborview Injury Prevention and Research Center
Study Overview
Official Title:
Parents Helping Infants Study Preventing Shaken Baby Syndrome and Child Abuse
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 womenfamilies 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 bibburp 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 Babys 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
In this randomized controlled trial we will enroll a total of 3000 womenfamilies 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 bibburp 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 Babys 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
Detailed Description:
The specific goals of the program are
1 To change the understanding ie knowledge and attitudes and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying
2 To change the behavior of parents to increase caregiving contact in response to crying but to walk away if frustrated
3 To provide parents with the ability to communicate to other caregivers relatives baby-sitters the knowledge and behavior to reduce frustration induced by inconsolable crying
4 To provide effective knowledge skills and teaching materials to health care providers in direct contact with parents concerning crying shaking and abuse
5 To reduce the incidence of physical abuse and shaken baby syndrome under one year
6 To have the Period of PURPLE Crying program adopted as a nationwide early intervention project
1 To change the understanding ie knowledge and attitudes and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying
2 To change the behavior of parents to increase caregiving contact in response to crying but to walk away if frustrated
3 To provide parents with the ability to communicate to other caregivers relatives baby-sitters the knowledge and behavior to reduce frustration induced by inconsolable crying
4 To provide effective knowledge skills and teaching materials to health care providers in direct contact with parents concerning crying shaking and abuse
5 To reduce the incidence of physical abuse and shaken baby syndrome under one year
6 To have the Period of PURPLE Crying program adopted as a nationwide early intervention project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None