Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Period of PURPLE Crying: An Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying

Conditions
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Shaken Baby Syndrome

Intervention / Treatment
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* Behavioral: The Period of PURPLE Crying Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Randomized controlled trial, Community education, Shaken Baby Syndrome, Crying, Colic