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Prevention of Shaken Baby Syndrome

Primary Purpose

Child Abuse, Shaken Baby Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education about infant crying
Sponsored by
Harborview Injury Prevention and Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Abuse focused on measuring abuse

Eligibility Criteria

1 Day - 4 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects must be new parents or parents to be who are either: 1) attending participating prenatal classes; 2) delivering a baby at the participating hospital; or 3) visiting a PSPRN (Puget Sound Pediatric Research Network) pediatrician for infant care. Only parents of infants born at > 34 weeks gestation are eligible. Exclusion Criteria: Parents of infants who have serious medical conditions. Parents who don't speak and read English. Parents of infants born at < 34 weeks gestation.

Sites / Locations

  • Harborview Injruy Prevention and Research CenterRecruiting

Outcomes

Primary Outcome Measures

Knowledge and attitudes about crying, shaking and abuse
Caregiver behavior
Parenting sense of competence
Maternal depression

Secondary Outcome Measures

Full Information

First Posted
March 18, 2005
Last Updated
June 23, 2005
Sponsor
Harborview Injury Prevention and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00105963
Brief Title
Prevention of Shaken Baby Syndrome
Official Title
Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Harborview Injury Prevention and Research Center

4. Oversight

5. Study Description

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. Our hypothesis is that the Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through changes in knowledge, attitudes and behaviors about early infant crying, especially inconsolable crying. In this 3-year project, we will implement and evaluate an intervention program in selected prenatal classes, hospitals, and primary care pediatric practices. In this randomized, controlled trial, we will enroll a total of 3000 women/families who are about to give birth or have just given birth to a healthy infant. At each of the three sites (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects. Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp cloth) about infant crying. The other half, the control group, will receive comparable materials on infant safety. All subjects will be asked to complete a brief questionnaire at the time of enrollment (pre test), review the materials they receive, complete the Baby's Day Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire (post test) when the infant is 8 weeks of age.
Detailed Description
The specific goals of the 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 behavior of parents to increase caregiving contact in response to crying but to 'walk away' if frustrated; To provide parents with the ability to communicate to other caregivers (relatives, baby-sitters) the knowledge and behavior to reduce frustration induced by inconsolable crying; To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse; To reduce the incidence of physical abuse and shaken baby syndrome under one year; To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Abuse, Shaken Baby Syndrome
Keywords
abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Education about infant crying
Primary Outcome Measure Information:
Title
Knowledge and attitudes about crying, shaking and abuse
Title
Caregiver behavior
Title
Parenting sense of competence
Title
Maternal depression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be new parents or parents to be who are either: 1) attending participating prenatal classes; 2) delivering a baby at the participating hospital; or 3) visiting a PSPRN (Puget Sound Pediatric Research Network) pediatrician for infant care. Only parents of infants born at > 34 weeks gestation are eligible. Exclusion Criteria: Parents of infants who have serious medical conditions. Parents who don't speak and read English. Parents of infants born at < 34 weeks gestation.
Facility Information:
Facility Name
Harborview Injruy Prevention and Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick P Rivara, MD
Phone
206-744-9449
Email
fpr@u.washington.edu
First Name & Middle Initial & Last Name & Degree
Frederick P Rivara, MD
First Name & Middle Initial & Last Name & Degree
James taylor, MD
First Name & Middle Initial & Last Name & Degree
Liliana Lengua, PhD
First Name & Middle Initial & Last Name & Degree
Ron Barr, MD
First Name & Middle Initial & Last Name & Degree
Marilyn Sandberg, BA

12. IPD Sharing Statement

Citations:
PubMed Identifier
23650295
Citation
Radesky JS, Zuckerman B, Silverstein M, Rivara FP, Barr M, Taylor JA, Lengua LJ, Barr RG. Inconsolable infant crying and maternal postpartum depressive symptoms. Pediatrics. 2013 Jun;131(6):e1857-64. doi: 10.1542/peds.2012-3316. Epub 2013 May 6.
Results Reference
derived
Links:
URL
http://www.hiprc.org
Description
Related Info

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Prevention of Shaken Baby Syndrome

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