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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. 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
Information provided by:
Harborview Injury Prevention and Research Center

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.

Condition or disease Intervention/treatment Phase
Child Abuse Shaken Baby Syndrome Behavioral: Education about infant crying Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse
Study Start Date : January 2005
Study Completion Date : August 2006

Primary Outcome Measures :
  1. Knowledge and attitudes about crying, shaking and abuse
  2. Caregiver behavior
  3. Parenting sense of competence
  4. Maternal depression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00105963

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United States, Washington
Harborview Injruy Prevention and Research Center Recruiting
Seattle, Washington, United States, 98104
Contact: Frederick P Rivara, MD    206-744-9449   
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         
Sponsors and Collaborators
Harborview Injury Prevention and Research Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00105963    
Other Study ID Numbers: HIPRCSBS-01
First Posted: March 21, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2005
Keywords provided by Harborview Injury Prevention and Research Center:
Additional relevant MeSH terms:
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Shaken Baby Syndrome
Pathologic Processes
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries