Prevention Harmful EffectsNCT01619202
Comparing Driving Performance Among Trained and Untrained Drivers Using a Driving Simulator
A study testing Risk Anticipation -Perception Training in people with Prevention Harmful Effects and Accidents, Traffic, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to examine differences in driving performance on a simulated driving assessment between novice teen drivers who receive the Risk Anticipation-Perception Training (RAPT) program and novice teen drivers who do not receive the training program. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects, Accidents, Traffic, Accident Prevention
- What is being tested?
- Risk Anticipation -Perception Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2013
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Holds a valid driver's license for less than or equal to 180 days
- 16 - 18 years of age
Who cannot join
- Self-reports claustrophobia, migraine headaches, and/or motion sickness
- Females who are pregnant
- Previously participated in another CHOP driving simulator study
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison of Driving Performance Among Trained and Untrained Novice Drivers: Validation of a Multidimensional Simulated Driving Assessment
The purpose of this study is to examine differences in driving performance on a simulated driving assessment between novice teen drivers who receive the Risk Anticipation-Perception Training (RAPT) program and novice teen drivers who do not receive the training program.
Read the detailed description
Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Driving simulators are a safer alternative to on-road assessments that are often affordable and can provide experimental control for research. Though driving simulators have advantages for evaluating driving performance in teens, there are gaps in the literature on the validity of a multidimensional outcome of driving performance in a simulator. To further examine the validity of a multidimensional measure of driving performance in a simulator, we compare simulated driving performance among teens who are trained hazard anticipation-perception training and those who are not.
- Being tested
- Risk Anticipation -Perception Training
- Keywords
- accident prevention, Adolescent, examination, automobile driver, Driving simulator, Young drivers, Driving education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Anticipation -Perception TrainingBehavioural
Also called RAPT
Web-based computer training program designed to teach novice teen drivers how to properly scan for hazards
| Study group | Role | What they receive |
|---|---|---|
| Risk Anticipation-Perception Training | Experimental | Complete the Risk Anticipation-Perception Training (RAPT) program Receives: Behavioral: Risk Anticipation -Perception Training |
| No training program | No intervention | Does not complete the Risk Anticipation-Perception Training (RAPT) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated driving performance measured by the number of errors made or the lack thereof, during a series of simulated drives.
Simulated driving performance will be measured by the number of driving errors made during the simulated drives. The simulated driving performance will be compared across each arm, Intervention and Control. Intervention arm: Simulated driving performance will be measured at least 1 week after completion of the RAPT (Hazard Awareness) training program; Control arm: Simulated driving performance will be measured after enrollment and completion of pre-assessment measures.
Measured: at least 1 week after training or enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Harmful EffectsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, National Institute of Nursing Research (NINR), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Flaura K Winston, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619202
- Sponsor's protocol ID
- 12-009288
- Other IDs
- K99NR013548
- Status last verified
- Jan 2015
- First submitted
- 6 Jun 2012
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Driving Performance Among Trained and Untrained Novice Drivers: Validation of a Multidimensional Simulated Driving Assessment
- ClinicalTrials.gov ID
- NCT01619202
- Acronym / sponsor ID
- 12-009288
- Keywords
- accident prevention, Adolescent, examination, automobile driver, Driving simulator, Young drivers, Driving education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, National Institute of Nursing Research (NINR), University of Pennsylvania
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jun 2012 (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.
The purpose of this study is to examine differences in driving performance on a simulated driving assessment between novice teen drivers who receive the Risk Anticipation-Perception Training (RAPT) program and novice teen drivers who do not receive the training program.
Detailed description
Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Driving simulators are a safer alternative to on-road assessments that are often affordable and can provide experimental control for research. Though driving simulators have advantages for evaluating driving performance in teens, there are gaps in the literature on the validity of a multidimensional outcome of driving performance in a simulator. To further examine the validity of a multidimensional measure of driving performance in a simulator, we compare simulated driving performance among teens who are trained hazard anticipation-perception training and those who are not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Anticipation-Perception Training | Experimental | Behavioral: Risk Anticipation -Perception TrainingComplete the Risk Anticipation-Perception Training (RAPT) program |
| No training program | No intervention | –Does not complete the Risk Anticipation-Perception Training (RAPT) program |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Holds a valid driver's license for less than or equal to 180 days
- 16 - 18 years of age
Key exclusion criteria (4 listed)
- Self-reports claustrophobia, migraine headaches, and/or motion sickness
- Females who are pregnant
- Previously participated in another CHOP driving simulator study
- Non-English Speaking
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 |
|---|---|---|
| Risk Anticipation -Perception TrainingAlso: RAPTWeb-based computer training program designed to teach novice teen drivers how to properly scan for hazards | Behavioural | Risk Anticipation-Perception Training |
Primary outcome
Simulated driving performance measured by the number of errors made or the lack thereof, during a series of simulated drives.
Time frame: at least 1 week after training or enrollment
Simulated driving performance will be measured by the number of driving errors made during the simulated drives. The simulated driving performance will be compared across each arm, Intervention and Control. Intervention arm: Simulated driving performance will be measured at least 1 week after completion of the RAPT (Hazard Awareness) training program; Control arm: Simulated driving performance will be measured after enrollment and completion of pre-assessment measures.
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 26 Jan 2015.
Related trials for Prevention Harmful Effects
Not yet recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
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.
Flaura K Winston, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Anticipation -Perception Training in people with Prevention Harmful Effects and Accidents, Traffic, run by Children's Hospital of Philadelphia 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 2 inclusion and 4 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 26 Jan 2015. 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?
Simulated driving performance measured by the number of errors made or the lack thereof, during a series of simulated drives. (time frame: at least 1 week after training or enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015; AzTrials last refreshed its copy on 28 Oct 2026.