Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175422
Status:
COMPLETED
Last Update Posted:
2010-12-17
First Post:
2005-09-11
Brief Title:
Parents Helping Infants Study Educational Intervention to Change the Knowledge Attitudes and Behaviour of New Parents About Early Infant Crying
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Period of PURPLE Crying An Educational Intervention to Change the Knowledge Attitudes and Behaviour of New Parents About Early Infant Crying
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
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 The investigators hypothesis is that the Period of PURPLE Crying intervention program can be effective in reducing the shaking and abuse of infants through changes in knowledge attitudes and behaviours about early infant crying especially inconsolable crying
Detailed Description:
The Period of PURPLE Crying phrase refers to the educational information and the action steps that caregivers need to know about the properties of early crying in normally developing infants that are uniformly frustrating to caregivers The study will be implemented and evaluated in 1000 new mothers by public health nurses during newborn home care visits in the Vancouver Coastal and Fraser Health Authorities There are two treatment arms in the study The first half of all subjects n500 will receive the PURPLE intervention materials a video and a pamphlet about infant crying The second arm will receive comparable materials on infant safety and SIDS
Specific goals of the research 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 behaviour of parents to increase care giving contact in response to crying but to walk away if frustrated or angry
3 To provide parents with the ability to educate other caregivers relatives baby sitters to reduce frustration induced by inconsolable crying and obtain help if needed
4 To provide parents with the knowledge to protect their infants from occasional caregivers who could harm their infants because of the frustrating nature of early crying
5 To provide effective knowledge skills and teaching materials to regional health care providers in direct contact with parents concerning crying shaking and abuse
Specific goals of the research 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 behaviour of parents to increase care giving contact in response to crying but to walk away if frustrated or angry
3 To provide parents with the ability to educate other caregivers relatives baby sitters to reduce frustration induced by inconsolable crying and obtain help if needed
4 To provide parents with the knowledge to protect their infants from occasional caregivers who could harm their infants because of the frustrating nature of early crying
5 To provide effective knowledge skills and teaching materials to regional health care providers in direct contact with parents concerning crying shaking and abuse
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