TraumaNCT01402856
Teenage Driving Safety Study: An Emergency Medicine-Trauma Collaborative Study
An observational study of Trauma, run by Lehigh Valley Hospital at 1 site in United States.
Trial summary
Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Education
- How many people
- 3,750 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students in the tenth, eleventh, and twelfth grades
Who may be able to join
- Teenagers perceived to be students driving near school property.
- Teenagers perceived to be of driving age.
- Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.
- Any driver driving near school property, which is perceived to be older than of high school age.
Who cannot join
- Teenagers perceived as non-attendees of the nearby school.
- Teenagers perceived not to be of driving age.
- Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.
- Any driver who does not meet the above criteria.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
About this study
Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Insufficient driving experience puts teenagers at a disadvantage in detecting and responding to hazards while driving. Factors contributing to distracted driving (a diversion in the driver's attention from the road) may include: talking or text messaging on a cell phone, applying makeup, having multiple passengers, listening to loud music, eating/drinking, smoking or reading while driving.
This is a prospective study designed to evaluate the effect of an educational program on the risks associated with distracted driving for teenage drivers. The researchers will compare cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New Jersey, where cell phone laws exist, and will educate the beginner driver on the potential dangers associated with driving without a seat belt, substance use, and participating in distracting driving behaviors. Knowledge of state laws will also be assessed.
Read more
Objectives
- Educate participants on the potential dangers of distracted driving.
- Evaluate the impact of the educational program on teenage distracted driving behaviors by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.
- Quantify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.
- Qualify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, anonymous observation, and anonymous voicemails, text messages, and/or emails pre, post, and delayed post education.
Qualify distracted driving behavior in adults through anonymous observations near local area high schools.
- Compare teenage driving behaviors as reported and observed between Pennsylvania and New Jersey.
- Compare seat belt usage, driving behaviors, and substance use in the study population to the state and national averages pre and post education.
- Compare averages of student's knowledge of state driving laws pre and post education.
Read the detailed description
Within the 2007-2008 school year, Phillipsburg High School in Phillipsburg, New Jersey, and Southern Lehigh High School in Center Valley, Pennsylvania have agreed to take part in an educational program targeting high school students on the risks associated with distracted driving behaviors. The educational program will be approximately 60-minutes in length utilizing education material including but not limited to: a 5-10 minute DVD illustrating a teenager's real-life experience of the devastating effects of distracted driving, other videos placing the viewer in the driver's seat, power point presentations of state and national statistics related to seat belt usage, mortality, and substance use, overview of state laws, demonstrations relating to the physics of an accident, and interactive games simulating driving while distracted.
As part of the educational program, teachers will be asked to distribute an anonymous survey and a state law quiz to the students. The teachers will be provided with scripted material to use for describing the purpose of the activity and for instructing the students how to fill out the survey and state law quiz. This data will be obtained at three different time intervals (pre education, post education, and delayed post education) and will assess driving and distracted driving behaviors such as seat belt use, cell phone use, audio habits, eating while driving, substance use, personal hygiene habits, frequency and number of passengers, and knowledge of state laws.
During the educational program, students will be given an anonymous research phone number and/or email address for which they will be encouraged to leave any voicemails, text messages, and/or emails with experiences they feel are important to teenage driving. Qualitative data obtained from any anonymous communication will be received by a non-study team member, and will be sanitized of all caller numbers or identifiers.
In addition to the educational program, study team members will anonymously observe student and adult drivers pulling into and out of school parking lots, or around school property, in order to qualify their driving behaviors. Observed behaviors of students and adults will be compared for any similarities. Observers will record seat belt use, number or passengers in cars and any other witnessed distracted driving behaviors. Observations will be anonymous and will not take place on school property. Student observations will take place pre, post, and delayed post the education session. Adult observations will occur one time, independent of student observations, as the adults will not be receiving the educational intervention provided by the study. Freedom and Liberty High Schools in Bethlehem, Pennsylvania, will be utilized as the control group for this study. These schools will not receive the education, however, will be surveyed, quizzed and observed at the same time intervals as the study group.
- Conditions
- Trauma
- Being tested
- Education
- Keywords
- Prevention, Adolescent, Trauma, Driving
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
An educational program targeting HS students on the risks of distracted driving that was 60-min long \& utilized: a 5-10 min DVD on a teenager's real-life experience of the devastating effects of distracted driving, other videos placing the viewer in the driver's seat, power point presentations of state and national statistics related to seat belt usage, mortality, and substance use, overview of state laws, demonstrations of the physics of an accident, \& interactive games simulating distracted driving.
| Study group | Role | What they receive |
|---|---|---|
| Southern Lehigh HS, PA School District | This school will not receive the education, yet, will be surveyed, quizzed and observed at the same time. Receives: Other: Education | |
| Bethlehem HS, PA Area School District | Freedom \& Liberty HS's in Bethlehem, PA will serve as the study's control group. | |
| Phillipsburg HS, NJ Area School District | This school will not receive the education, yet, will be surveyed, quizzed and observed at the same time. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in distracted driving behavior at one year
distracted driving behaviors will be quantified by anonymous observations, state law quiz results, anonymous observations, anonymous text messages/emails/voicemails pre-, post and delayed post education
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 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 TraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Gavin C Barr, Jr, MD, Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402856
- Sponsor's protocol ID
- 1-20071204
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2011
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Murphy S., Kane B., Barr G., Rupp V., Fredericks K., Barraco R., Anselmo T., Reed J., The Correlation Between Adolescent-Reported Parental Driving Behaviors and Observed Adult Driving Behaviors. Annals of Emergency Medicine 54(3):s126-s127, 2009
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teenage Driving Safety Study: An Emergency Medicine-Trauma Collaborative Study
- ClinicalTrials.gov ID
- NCT01402856
- Acronym / sponsor ID
- 1-20071204
- Conditions
- Trauma
- Keywords
- Prevention, Adolescent, Trauma, Driving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,750 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jul 2011 (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.
Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Insufficient driving experience puts teenagers at a disadvantage in detecting and responding to hazards while driving. Factors contributing to distracted driving (a diversion in the driver's attention from the road) may include: talking or text messaging on a cell phone, applying makeup, having multiple passengers, listening to loud music, eating/drinking, smoking or reading while driving.
This is a prospective study designed to evaluate the effect of an educational program on the risks associated with distracted driving for teenage drivers. The researchers will compare cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New Jersey, where cell phone laws exist, and will educate the beginner driver on the potential dangers associated with driving without a seat belt, substance use, and participating in distracting driving behaviors. Knowledge of state laws will also be assessed.
Objectives
- Educate participants on the potential dangers of distracted driving.
- Evaluate the impact of the educational program on teenage distracted driving behaviors by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.
- Quantify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.
- Qualify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, anonymous observation, and anonymous voicemails, text messages, and/or emails pre, post, and delayed post education.
Qualify distracted driving behavior in adults through anonymous observations near local area high schools.
- Compare teenage driving behaviors as reported and observed between Pennsylvania and New Jersey.
- Compare seat belt usage, driving behaviors, and substance use in the study population to the state and national averages pre and post education.
- Compare averages of student's knowledge of state driving laws pre and post education.
Detailed description
Within the 2007-2008 school year, Phillipsburg High School in Phillipsburg, New Jersey, and Southern Lehigh High School in Center Valley, Pennsylvania have agreed to take part in an educational program targeting high school students on the risks associated with distracted driving behaviors. The educational program will be approximately 60-minutes in length utilizing education material including but not limited to: a 5-10 minute DVD illustrating a teenager's real-life experience of the devastating effects of distracted driving, other videos placing the viewer in the driver's seat, power point presentations of state and national statistics related to seat belt usage, mortality, and substance use, overview of state laws, demonstrations relating to the physics of an accident, and interactive games simulating driving while distracted.
As part of the educational program, teachers will be asked to distribute an anonymous survey and a state law quiz to the students. The teachers will be provided with scripted material to use for describing the purpose of the activity and for instructing the students how to fill out the survey and state law quiz. This data will be obtained at three different time intervals (pre education, post education, and delayed post education) and will assess driving and distracted driving behaviors such as seat belt use, cell phone use, audio habits, eating while driving, substance use, personal hygiene habits, frequency and number of passengers, and knowledge of state laws.
During the educational program, students will be given an anonymous research phone number and/or email address for which they will be encouraged to leave any voicemails, text messages, and/or emails with experiences they feel are important to teenage driving. Qualitative data obtained from any anonymous communication will be received by a non-study team member, and will be sanitized of all caller numbers or identifiers.
In addition to the educational program, study team members will anonymously observe student and adult drivers pulling into and out of school parking lots, or around school property, in order to qualify their driving behaviors. Observed behaviors of students and adults will be compared for any similarities. Observers will record seat belt use, number or passengers in cars and any other witnessed distracted driving behaviors. Observations will be anonymous and will not take place on school property. Student observations will take place pre, post, and delayed post the education session. Adult observations will occur one time, independent of student observations, as the adults will not be receiving the educational intervention provided by the study. Freedom and Liberty High Schools in Bethlehem, Pennsylvania, will be utilized as the control group for this study. These schools will not receive the education, however, will be surveyed, quizzed and observed at the same time intervals as the study group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Southern Lehigh HS, PA School District | – | Other: EducationThis school will not receive the education, yet, will be surveyed, quizzed and observed at the same time. |
| Bethlehem HS, PA Area School District | – | –Freedom \& Liberty HS's in Bethlehem, PA will serve as the study's control group. |
| Phillipsburg HS, NJ Area School District | – | Other: EducationThis school will not receive the education, yet, will be surveyed, quizzed and observed at the same time. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students in the tenth, eleventh, and twelfth grades
Key inclusion criteria (4 listed)
- Teenagers perceived to be students driving near school property.
- Teenagers perceived to be of driving age.
- Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.
- Any driver driving near school property, which is perceived to be older than of high school age.
Key exclusion criteria (5 listed)
- Teenagers perceived as non-attendees of the nearby school.
- Teenagers perceived not to be of driving age.
- Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.
- Any driver who does not meet the above criteria.
- -
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 |
|---|---|---|
| EducationAn educational program targeting HS students on the risks of distracted driving that was 60-min long \& utilized: a 5-10 min DVD on a teenager's real-life experience of the devastating effects of distracted driving, other videos placing the viewer in the driver's seat, power point presentations of state and national statistics related to seat belt usage, mortality, and substance use, overview of state laws, demonstrations of the physics of an accident, \& interactive games simulating distracted driving. | Other | Phillipsburg HS, NJ Area School District, Southern Lehigh HS, PA School District |
Primary outcome
Change from baseline in distracted driving behavior at one year
Time frame: up to one year
distracted driving behaviors will be quantified by anonymous observations, state law quiz results, anonymous observations, anonymous text messages/emails/voicemails pre-, post and delayed post education
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 14 Oct 2016.
- Results publicationMurphy S., Kane B., Barr G., Rupp V., Fredericks K., Barraco R., Anselmo T., Reed J., The Correlation Between Adolescent-Reported Parental Driving Behaviors and Observed Adult Driving Behaviors. Annals of Emergency Medicine 54(3):s126-s127, 2009
- Individual participant dataSharing planned: No
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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.
Gavin C Barr, Jr, MD principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Lehigh Valley Hospital at 1 site in United States.
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 4 inclusion and 5 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline in distracted driving behavior at one year (time frame: up to one year). 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 NCT01402856, 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 14 Oct 2016.