Prevention of Shaken Baby Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00105963|
Recruitment Status : Unknown
Verified March 2005 by Harborview Injury Prevention and Research Center.
Recruitment status was: Recruiting
First Posted : March 21, 2005
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment|
|Child Abuse Shaken Baby Syndrome||Behavioral: Education about infant crying|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse|
|Study Start Date :||January 2005|
|Estimated Study Completion Date :||August 2006|
- Knowledge and attitudes about crying, shaking and abuse
- Caregiver behavior
- Parenting sense of competence
- Maternal depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105963
|United States, Washington|
|Harborview Injruy Prevention and Research Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Frederick P Rivara, MD 206-744-9449 email@example.com|
|Principal Investigator: Frederick P Rivara, MD|
|Sub-Investigator: James taylor, MD|
|Sub-Investigator: Liliana Lengua, PhD|
|Sub-Investigator: Ron Barr, MD|
|Sub-Investigator: Marilyn Sandberg, BA|