Prevention of Shaken Baby Syndrome

Child Abuse Clinical Trial

Official title:

Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00105963
• Other study ID #: HIPRCSBS-01
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2005
• Last updated: June 23, 2005
• Start date: January 2005
• Est. completion date: August 2006

Study information

• Verified date: March 2005
• Source: Harborview Injury Prevention and Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Abuse
• Shaken Baby Syndrome
• Syndrome

Intervention

Behavioral:
• Education about infant crying

Locations

Country	Name	City	State
United States	Harborview Injruy Prevention and Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Harborview Injury Prevention and Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and attitudes about crying, shaking and abuse
Primary	Caregiver behavior
Primary	Parenting sense of competence
Primary	Maternal depression

External Links

•   Link