Recruiting

Observational Study

Sponsor:

Harborview Injury Prevention and Research Center

Code:

NCT00105963

Conditions

Child Abuse

Shaken Baby Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Education about infant crying

Study Details

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

Study ID

NCT00105963

Start date

Jan, 2005

Status verified date

Mar, 2005

Completion date

Aug, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

3000 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Education about infant crying

Primary outcome measure

  • Knowledge and attitudes about crying, shaking and abuse [ Time Frame: undefined ]
  • Caregiver behavior [ Time Frame: undefined ]
  • Parenting sense of competence [ Time Frame: undefined ]
  • Maternal depression [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Harborview Injruy Prevention and Research Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Frederick P Rivara, MD

206-744-9449fpr@u.washington.edu

Principal Investigator:

Frederick P Rivara, MD

More Information

Sponsor

Harborview Injury Prevention and Research Center

Last update posted

Jun 24, 2005

Last verified

Mar, 2005

Keywords

  • abuse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harborview Injury Prevention and Research Center on 2005-06-24.