Clinical trial NCT00175422: Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Shaken Baby Syndrome
Keywords: Prevention
Randomized controlled trial
Community education
Shaken Baby Syndrome
Crying
Colic
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1833
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 (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:

1. 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;
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.

Eligibility criteria: Inclusion Criteria:

* New mothers of healthy infants born at \> 34 weeks gestation with access to a video or DVD player.

Exclusion Criteria:

* Mothers of: infants born at \< 34 weeks gestation; multiple infants (twins, triplets, etc.); or infants who have serious medical conditions.
* Mothers who don't speak and read English.

Primary outcomes:
measure: 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
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Community Child Health Research, BC Childrens and Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ronald G Barr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr RG, Barr M, Fujiwara T, Conway J, Catherine N, Brant R. Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. CMAJ. 2009 Mar 31;180(7):727-33. doi: 10.1503/cmaj.081419. Epub 2009 Mar 2.