Pennsylvania Abusive Head Trauma Prevention Program
Primary Purpose
Injury, Traumatic Brain Injury, Child Abuse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PA Abusive Head Trauma Prevention Program: State-wide
PA Abusive Head Trauma Prevention Program Booster: Central PA
Sponsored by
About this trial
This is an interventional prevention trial for Injury
Eligibility Criteria
Inclusion Criteria:
- Parents giving birth in a PA hospital
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
State-wide
Central PA
Arm Description
All parents of newborns in Pennsylvania hospitals will receive the parent education materials
All of Central PA new parents will receive the state-wide hospital-based intervention. In half of the 31 central PA counties, all primary care providers having offices in those counties provide an office-based booster intervention to new parents. The other half of central PA counties will receive the state-wide, hospital-based intervention, but not the office-based booster intervention.
Outcomes
Primary Outcome Measures
Incidence of abusive head trauma in infants
Secondary Outcome Measures
Full Information
NCT ID
NCT00727116
First Posted
July 30, 2008
Last Updated
February 6, 2015
Sponsor
Centers for Disease Control and Prevention
Collaborators
Pennsylvania Department of Health, American Academy of Pediatrics
1. Study Identification
Unique Protocol Identification Number
NCT00727116
Brief Title
Pennsylvania Abusive Head Trauma Prevention Program
Official Title
Pennsylvania Abusive Head Trauma Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Pennsylvania Department of Health, American Academy of Pediatrics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is designed to evaluate a statewide, hospital-based parent education program to prevent abusive head trauma (AHT) in Pennsylvania, and investigate the additional effectiveness and cost-effectiveness of "booster" sessions of parent education delivered to parents at primary care provider offices in central Pennsylvania.
Specific Aims:
Assess the effectiveness of an established statewide program of hospital-based postnatal parent education about violent infant shaking, provided at a single consistent point in time between the infant's birth and hospital discharge, in reducing the incidence of AHT.
Identify which component(s) are the most important mediators of the intervention's effectiveness; determine whether the intervention effect is more directly related to changes in perpetrator or caregiver behavior; and determine the effectiveness of the intervention among various socioeconomic groups.
Determine the cost effectiveness of the hospital-based program.
Establish the feasibility, additional costs, and effectiveness of a combined program of repeated exposure delivered both post-natally in the hospital and during follow up 2-, 4- and 6-month outpatient health maintenance visits with the pediatric care provider.
Detailed Description
Upon the birth of the child, all parents (mothers, and whenever possible, fathers or father figures) will be asked to read written materials and view an 8-minute video on the dangers of violent infant shaking. Parents will be asked to voluntarily sign a commitment statement affirming their receipt and understanding of the materials; these commitment statements will be sent to the Principal Investigator. A random subset of parent participants will be asked to voluntarily answer a short questionnaire about their impressions of the materials. In addition, 31 counties in central Pennsylvania will be randomly divided into two groups. In 15 counties, the hospital-based intervention will remain as described above. In the other 16 counties, all primary care providers having offices in those counties will be asked to provide all parents of newborns at the 2-, 4-, and 6-month immunization visits another set of written materials about violent infant shaking and voluntarily sign a response form that they read and understood the materials. Participating parents in this group will also be asked if they would be willing to complete a short telephone survey when the infant is 7 months old (and if so, asked to provide a telephone number). The telephone survey asks questions about the intervention materials and parents' perception of the information, and seeks to determine the mediators of a program effect. An invitation letter will be sent to a control group of parents who do not receive the office-based intervention to ask if they would be willing to complete the short telephone survey when their infant is 7 months old.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury, Traumatic Brain Injury, Child Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
949609 (Actual)
8. Arms, Groups, and Interventions
Arm Title
State-wide
Arm Type
Experimental
Arm Description
All parents of newborns in Pennsylvania hospitals will receive the parent education materials
Arm Title
Central PA
Arm Type
Experimental
Arm Description
All of Central PA new parents will receive the state-wide hospital-based intervention. In half of the 31 central PA counties, all primary care providers having offices in those counties provide an office-based booster intervention to new parents. The other half of central PA counties will receive the state-wide, hospital-based intervention, but not the office-based booster intervention.
Intervention Type
Behavioral
Intervention Name(s)
PA Abusive Head Trauma Prevention Program: State-wide
Intervention Description
Upon the birth of the child in a Pennsylvania hospital, all parents (mothers, and whenever possible, fathers or father figures) will be asked to read written materials and view an 8-minute video on the dangers of violent infant shaking. Parent education materials contain four key messages: crying is a normal infant behavior, how to keep calm when an infant is crying, how to help calm a crying infant, how to select other caregivers for your infant. Parents will be asked to voluntarily sign a commitment statement affirming their receipt and understanding of the materials.
Intervention Type
Behavioral
Intervention Name(s)
PA Abusive Head Trauma Prevention Program Booster: Central PA
Intervention Description
All primary care providers serving families of newborns in half of the counties in Central PA will be asked to provide all parents of newborns at the 2-, 4-, and 6-month immunization visits another set of written materials about violent infant shaking and voluntarily sign a response form that they read and understood the materials.
Primary Outcome Measure Information:
Title
Incidence of abusive head trauma in infants
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parents giving birth in a PA hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Dias, MD, FAAP
Organizational Affiliation
Penn State University Hershey Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15805350
Citation
Dias MS, Smith K, DeGuehery K, Mazur P, Li V, Shaffer ML. Preventing abusive head trauma among infants and young children: a hospital-based, parent education program. Pediatrics. 2005 Apr;115(4):e470-7. doi: 10.1542/peds.2004-1896.
Results Reference
background
Learn more about this trial
Pennsylvania Abusive Head Trauma Prevention Program
We'll reach out to this number within 24 hrs