- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105963
Prevention of Shaken Baby Syndrome
Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98104
- Recruiting
- Harborview Injruy Prevention and Research Center
-
Contact:
- Frederick P Rivara, MD
- Phone Number: 206-744-9449
- Email: fpr@u.washington.edu
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Principal Investigator:
- Frederick P Rivara, MD
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Sub-Investigator:
- James Taylor, MD
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Sub-Investigator:
- Liliana Lengua, PhD
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Sub-Investigator:
- Ron Barr, MD
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Sub-Investigator:
- Marilyn Sandberg, BA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Knowledge and attitudes about crying, shaking and abuse
|
Caregiver behavior
|
Parenting sense of competence
|
Maternal depression
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIPRCSBS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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