Trial record 2 of 7 for:    Shaken Baby Syndrome

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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175422
First received: September 11, 2005
Last updated: December 15, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Shaken Baby Syndrome
Behavioral: The Period of PURPLE Crying Program
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1833
Study Start Date: May 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175422

Locations
Canada, British Columbia
Centre for Community Child Health Research, BC Childrens and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Ronald G Barr, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ronald Barr, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175422     History of Changes
Other Study ID Numbers: B04-0785
Study First Received: September 11, 2005
Last Updated: December 15, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Prevention
Randomized controlled trial
Community education
Shaken Baby Syndrome
Crying
Colic

Additional relevant MeSH terms:
Shaken Baby Syndrome
Syndrome
Brain Injuries
Craniocerebral Trauma
Disease
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014