InjuryNCT00727116
Pennsylvania Abusive Head Trauma Prevention Program
A study testing PA Abusive Head Trauma Prevention Program: State-wide and PA Abusive Head Trauma Prevention Program Booster: Central PA in people with Injury and Traumatic Brain Injury, run by Centers for Disease Control and Prevention.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Injury, Traumatic Brain Injury, Child Abuse
- What is being tested?
- PA Abusive Head Trauma Prevention Program: State-wide and PA Abusive Head Trauma Prevention Program Booster: Central PA
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 949,609 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents giving birth in a PA hospital
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Injury, Traumatic Brain Injury, Child Abuse
- Being tested
- PA Abusive Head Trauma Prevention Program: State-wide, PA Abusive Head Trauma Prevention Program Booster: Central PA
- Medical subject headings
- Wounds and Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA Abusive Head Trauma Prevention Program: State-wideBehavioural
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.
PA Abusive Head Trauma Prevention Program Booster: Central PABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| State-wide | Experimental | All parents of newborns in Pennsylvania hospitals will receive the parent education materials Receives: Behavioral: PA Abusive Head Trauma Prevention Program: State-wide |
| 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. Receives: Behavioral: PA Abusive Head Trauma Prevention Program: State-wide; Behavioral: PA Abusive Head Trauma Prevention Program Booster: Central PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abusive head trauma in infants
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 949,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Pennsylvania Department of Health, American Academy of Pediatrics
- Responsible party
- Sponsor
- Investigators
- Mark Dias, MD, FAAP, Principal investigator, Penn State University Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727116
- Sponsor's protocol ID
- U49CE001274
- Status last verified
- Feb 2015
- First submitted
- 30 Jul 2008
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1542/peds.2004-1896.
PubMed 15805350
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pennsylvania Abusive Head Trauma Prevention Program
- ClinicalTrials.gov ID
- NCT00727116
- Acronym / sponsor ID
- U49CE001274
- Conditions
- Injury, Traumatic Brain Injury, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 949,609 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Pennsylvania Department of Health, American Academy of Pediatrics
- Study start
- Jan 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| State-wide | Experimental | Behavioral: PA Abusive Head Trauma Prevention Program: State-wideAll parents of newborns in Pennsylvania hospitals will receive the parent education materials |
| Central PA | Experimental | Behavioral: PA Abusive Head Trauma Prevention Program: State-wide, Behavioral: PA Abusive Head Trauma Prevention Program Booster: Central PAAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents giving birth in a PA hospital
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA Abusive Head Trauma Prevention Program: State-wideUpon 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. | Behavioural | Central PA, State-wide |
| PA Abusive Head Trauma Prevention Program Booster: Central PAAll 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. | Behavioural | Central PA |
Primary outcome
Incidence of abusive head trauma in infants
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Background: PubMed 15805350Dias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Dias, MD, FAAP principal investigator
Penn State University Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing PA Abusive Head Trauma Prevention Program: State-wide and PA Abusive Head Trauma Prevention Program Booster: Central PA in people with Injury and Traumatic Brain Injury, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abusive head trauma in infants (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.