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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
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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
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    Learn more about this trial

    Pennsylvania Abusive Head Trauma Prevention Program

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