Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying
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|ClinicalTrials.gov Identifier: NCT00175422|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Shaken Baby Syndrome||Behavioral: The Period of PURPLE Crying Program||Phase 1 Phase 2|
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 (n=500) 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:
- To change the understanding (i.e knowledge and attitudes) and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying;
- To change the behaviour of parents to increase care giving contact in response to crying but to 'walk away' if frustrated or angry;
- 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;
- 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;
- To provide effective knowledge, skills and teaching materials to regional health care providers in direct contact with parents concerning crying, shaking and abuse.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1833 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Period of PURPLE Crying: An Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
- Behavioral: The Period of PURPLE Crying Program
There are two treatment arms in the study. The first half of all subjects (n=500) 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.
- To demonstrate the effectiveness of the Period of PURPLE Crying program to change knowledge, attitudes and behavior about early infant crying and shaken baby syndrome in new parents at two months of life [ Time Frame: Two months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175422
|Canada, British Columbia|
|Centre for Community Child Health Research, BC Childrens and Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Ronald G Barr, MD||University of British Columbia|