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

December 15, 2010 updated by: University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Shaken Baby Syndrome

Intervention / Treatment

Behavioral: The Period of PURPLE Crying Program

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:

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

Enrollment (Actual)

1833

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V6H 3V4
    - Centre for Community Child Health Research, BC Childrens and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Time Frame: Two months	Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

Principal Investigator: Ronald G Barr, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria