Prevention of Shaken Baby Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Harborview Injury Prevention and Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Harborview Injury Prevention and Research Center
ClinicalTrials.gov Identifier:
NCT00105963
First received: March 18, 2005
Last updated: June 23, 2005
Last verified: March 2005

March 18, 2005
June 23, 2005
January 2005
Not Provided
  • Knowledge and attitudes about crying, shaking and abuse
  • Caregiver behavior
  • Parenting sense of competence
  • Maternal depression
Same as current
Complete list of historical versions of study NCT00105963 on ClinicalTrials.gov Archive Site
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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.

The specific goals of the 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 behavior of parents to increase caregiving contact in response to crying but to ‘walk away’ if frustrated;
  3. 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;
  4. To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse;
  5. To reduce the incidence of physical abuse and shaken baby syndrome under one year;
  6. To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Child Abuse
  • Shaken Baby Syndrome
Behavioral: Education about infant crying
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
August 2006
Not Provided

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.
Both
up to 4 Weeks
Yes
Not Provided
United States
 
NCT00105963
HIPRCSBS-01
Not Provided
Not Provided
Harborview Injury Prevention and Research Center
Not Provided
Not Provided
Harborview Injury Prevention and Research Center
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP