Novice Teen Driver TrainingNCT01498575
An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving
A study testing Teen driving plan in people with Novice Teen Driver Training, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The long-term goal of this research is to increase safe driving among novice teen drivers by increasing the quantity, quality and diversity of driving practice while accompanied by an adult. Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Novice Teen Driver Training
- What is being tested?
- Teen driving plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teen 16 or 17 years of age who holds a Pennsylvania (PA) learner permit, or plans to obtain a learner permit in < 1 month.
- Parent(s) or legal guardian(s) of a teen with his or her learner permit.
- Internet connection at home and other technical requirements to launch web program if needed.
Who cannot join
- Non-English speaking.
- Teen has practiced more than 5 hours behind the wheel or has taken more than 5 practice drives with a supervising adult prior to enrollment.
- Teen has received formal behind-the-wheel driver education instruction prior to enrollment with a certified driving instructor at a professional driver education company or in his/her school.
- Pregnant female teen subjects.
- Teen requires handicapped placard or license plate in order to drive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The long-term goal of this research is to increase safe driving among novice teen drivers by increasing the quantity, quality and diversity of driving practice while accompanied by an adult. In order to achieve the long term goal of the study, the investigators have developed a web-based intervention program known as Teen Driving Plan (TDP) intended to support high quality driving practice.
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). Inexperience is a fundamental factor in the high crash rate for novice teens. Safe and skilled driving is a complex task that involves behaviors (e.g., skills and actions) that vary and become increasingly challenging with increasing speed, unsafe road conditions and other hazards of the driving environment. Because teens are at their lowest lifetime risk of crashing when accompanied by an adult, adult-supervised practice provides a safe way for teens to gain needed experience under a variety of driving conditions. Unfortunately, few teens receive sufficient quantity, quality and diversity of adult-supervised practice prior to licensure.
The objective of the proposed research is to compare how the driving training process and the results of that training process differ between a group of young learning permit holders in families that have access to TDP (the intervention group) from the training process and the results of that process in an otherwise similar group of teens in families with no TDP access (the control group). The investigators hypothesize that teens given access to TDP will demonstrate greater competence and safety in a standardized on-road driving assessment than teens with no TDP access.
- Conditions
- Novice Teen Driver Training
- Being tested
- Teen driving plan
- Keywords
- Teen driving, Behind the wheel practice driving, Parent supervision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen driving planBehavioural
Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.
| Study group | Role | What they receive |
|---|---|---|
| Teen Driving Plan | Experimental | Access to web-based driving intervention Receives: Behavioral: Teen driving plan |
| Usual practice | No intervention | Use of typical supervised practice driving resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Driving Performance in On-road Assessment (ODA) Test
The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.
Measured: 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Novice Teen Driver TrainingStudies 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
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- State Farm Insurance Co., Bryn Mawr Rehabilitation Hospital, GFK Knowledge Networks
- Responsible party
- Sponsor
- Investigators
- Dennis R Durbin, MD, MSCE, Principal investigator, Chidlren's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498575
- Sponsor's protocol ID
- 11-008203
- Status last verified
- Mar 2015
- First submitted
- 20 Dec 2011
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252.
PubMed 24957844Winston FK, Mirman JH, Curry AE, Pfeiffer MR, Elliott MR, Durbin DR. Engagement with the TeenDrivingPlan and diversity of teens' supervised practice driving: lessons for internet-based learner driver interventions. Inj Prev. 2015 Feb;21(1):4-9. doi: 10.1136/injuryprev-2014-041212. Epub 2014 Jun 10.
PubMed 24916684
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving
- ClinicalTrials.gov ID
- NCT01498575
- Acronym / sponsor ID
- 11-008203
- Conditions
- Novice Teen Driver Training
- Keywords
- Teen driving, Behind the wheel practice driving, Parent supervision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- State Farm Insurance Co., Bryn Mawr Rehabilitation Hospital, GFK Knowledge Networks
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this research is to increase safe driving among novice teen drivers by increasing the quantity, quality and diversity of driving practice while accompanied by an adult. In order to achieve the long term goal of the study, the investigators have developed a web-based intervention program known as Teen Driving Plan (TDP) intended to support high quality driving practice.
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). Inexperience is a fundamental factor in the high crash rate for novice teens. Safe and skilled driving is a complex task that involves behaviors (e.g., skills and actions) that vary and become increasingly challenging with increasing speed, unsafe road conditions and other hazards of the driving environment. Because teens are at their lowest lifetime risk of crashing when accompanied by an adult, adult-supervised practice provides a safe way for teens to gain needed experience under a variety of driving conditions. Unfortunately, few teens receive sufficient quantity, quality and diversity of adult-supervised practice prior to licensure.
The objective of the proposed research is to compare how the driving training process and the results of that training process differ between a group of young learning permit holders in families that have access to TDP (the intervention group) from the training process and the results of that process in an otherwise similar group of teens in families with no TDP access (the control group). The investigators hypothesize that teens given access to TDP will demonstrate greater competence and safety in a standardized on-road driving assessment than teens with no TDP access.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Driving Plan | Experimental | Behavioral: Teen driving planAccess to web-based driving intervention |
| Usual practice | No intervention | –Use of typical supervised practice driving resources |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Teen 16 or 17 years of age who holds a Pennsylvania (PA) learner permit, or plans to obtain a learner permit in < 1 month.
- Parent(s) or legal guardian(s) of a teen with his or her learner permit.
- Internet connection at home and other technical requirements to launch web program if needed.
Key exclusion criteria (5 listed)
- Non-English speaking.
- Teen has practiced more than 5 hours behind the wheel or has taken more than 5 practice drives with a supervising adult prior to enrollment.
- Teen has received formal behind-the-wheel driver education instruction prior to enrollment with a certified driving instructor at a professional driver education company or in his/her school.
- Pregnant female teen subjects.
- Teen requires handicapped placard or license plate in order to drive.
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 |
|---|---|---|
| Teen driving planWeb-based intervention designed to facilitate parent supervised practice driving with novice teen driver. | Behavioural | Teen Driving Plan |
Primary outcome
Late Driving Performance in On-road Assessment (ODA) Test
Time frame: 24 weeks after enrollment
The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24957844Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252.
- Derived from this study: PubMed 24916684Winston FK, Mirman JH, Curry AE, Pfeiffer MR, Elliott MR, Durbin DR. Engagement with the TeenDrivingPlan and diversity of teens' supervised practice driving: lessons for internet-based learner driver interventions. Inj Prev. 2015 Feb;21(1):4-9. doi: 10.1136/injuryprev-2014-041212. Epub 2014 Jun 10.
Related trials for Novice Teen Driver Training
Recruiting
Driver Education Research Study
Risk Reduction Behavior, Injuries
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.
Dennis R Durbin, MD, MSCE principal investigator
Chidlren'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 Teen driving plan in people with Novice Teen Driver Training, 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 3 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 17 Mar 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?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Late Driving Performance in On-road Assessment (ODA) Test (time frame: 24 weeks after enrollment). 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 NCT01498575, which also lists 2 linked publications.
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 17 Mar 2015.