Pennsylvania Abusive Head Trauma Prevention Program

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Pennsylvania Department of Health
American Academy of Pediatrics
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00727116
First received: July 30, 2008
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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:

  1. 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.
  2. Identify while 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.
  3. Determine the cost effectiveness of the hospital-based program.
  4. 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.

Condition Intervention
Injury
Traumatic Brain Injury
Child Abuse
Behavioral: PA Abusive Head Trauma Prevention Program: State-wide
Behavioral: PA Abusive Head Trauma Prevention Program Booster: Central PA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pennsylvania Abusive Head Trauma Prevention Program

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence of abusive head trauma in infants [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300000
Study Start Date: January 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: State-wide
All parents of newborns in Pennsylvania hospitals will receive the parent education materials
Behavioral: PA Abusive Head Trauma Prevention Program: State-wide
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.
Experimental: Central PA
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.
Behavioral: PA Abusive Head Trauma Prevention Program: State-wide
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.
Behavioral: PA Abusive Head Trauma Prevention Program Booster: Central PA
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents giving birth in a PA hospital
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727116

Sponsors and Collaborators
Pennsylvania Department of Health
American Academy of Pediatrics
Investigators
Principal Investigator: Mark Dias, MD, FAAP Penn State University Hershey Medical Center
  More Information

Publications:
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00727116     History of Changes
Other Study ID Numbers: U49/CE-001274
Study First Received: July 30, 2008
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014