Pennsylvania Abusive Head Trauma Prevention Program - Full Text View

Sponsors and Collaborators:	Centers for Disease Control and Prevention Pennsylvania Department of Health American Academy of Pediatrics
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00727116

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:

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 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.
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.

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

MedlinePlus related topics: Child Abuse Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Pennsylvania Abusive Head Trauma Prevention Program

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
State-wide: Experimental 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.
Central PA: Experimental 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.

Arms

Assigned Interventions

State-wide: Experimental

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.

Central PA: Experimental

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

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

Sponsors and Collaborators

Centers for Disease Control and Prevention

Pennsylvania Department of Health

American Academy of Pediatrics

Investigators

Principal Investigator:

Mark Dias, MD, FAAP

Penn State University Hershey Medical Center

More Information

Publications:

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.

Responsible Party:	Pennsylvania State University Hershey Medical Center ( Mark Dias, MD, FAAP )
Study ID Numbers:	U49/CE-001274
Study First Received:	July 30, 2008
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00727116
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009