Prevention of Shaken Baby Syndrome

NCT00105963 | Unknown

• 1 other identifier: HIPRCSBS-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Abuse; Shaken Baby Syndrome

Keywords

abuse

Outcome Measures

Primary Outcomes (4)

• Knowledge and attitudes about crying, shaking and abuse

• Caregiver behavior

• Parenting sense of competence

• Maternal depression

Interventions

Education about infant crying BEHAVIORAL

Eligibility Criteria

• Age: 1 Day - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Parents of infants who have serious medical conditions.
• Parents who don't speak and read English.
• Parents of infants born at \< 34 weeks gestation.

Sponsors & Collaborators

• Harborview Injury Prevention and Research Center: lead

Study Sites (1)

Harborview Injruy Prevention and Research Center

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 23650295 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Shaken Baby Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2005
• First Posted: March 21, 2005
• Study Start: January 1, 2005
• Study Completion: August 1, 2006
• Last Updated: June 24, 2005

Record last verified: 2005-03

Locations

US (1)