ClinicalTrials.gg
RecruitingNCT06413927DRIVERUpdated Apr 6, 2026

Driver Education Research Study

An interventional study of Online Vehicle and Driver Safety Education and Online Driver Skills Training in Risk Reduction Behavior, Injuries and Accident, Traffic, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 16 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
16 Years to 17 Years
Sex
All
01

Study summary

This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure.

Read the detailed description

Motor vehicle crashes remain high in young drivers, despite graduated driver licensing laws that put restrictions on driving and delay licensure. Typically, data trends show that crash risk is highest right after licensure, in the early months of independent driving. Additional studies of different driver training interventions have shown some evidence that it is possible to improve skills and reduce crashes early in licensure for young drivers. However, Pennsylvania and many other states have no professional training requirements for young drivers.

This study will test the effectiveness of different types of driver training programs for reducing young new driver crash risk early after licensure.

Up to 1,200 adolescent learner drivers in Pennsylvania will be recruited for this trial (to get up to 1,000 evaluable participants). Participants will be recruited through Primary Care Clinics at Children's Hospital of Philadelphia and from the surrounding community to take part in a study that will continue through the learner phase and for 6 months after licensure. Participants will give informed consent and be asked to complete some baseline surveys and cognitive tasks, and a virtual driving assessment in-person during a clinical or other visit. All will receive care-as-usual.

Participants will also be followed through the learner phase with a smartphone app that monitors driving trips and monthly surveys that can be completed at home. In the learner phase, participants will randomly receive one of three interventions. One group of participants will receive professional behind-the-wheel training with a local driving school instructor. Another group will receive a modern online driver training course. Another group will receive an online vehicle and driver safety education. Participants randomly assigned to the behind-the-wheel training group will be required to download and use an app to log and track their driving practice hours. Use of this app will be optional for participants randomly assigned to the other groups.

After the learner phase, participants will be given an online hazard skills test, online surveys, and second virtual driving assessment, and state license examination and will be followed for 6 months after licensure, with online surveys at 2, 4, and 6 months after licensure, and with continued driver trip monitoring through the smartphone app.

02

Conditions studied

  • Risk Reduction Behavior
  • Injuries
  • Accident, Traffic
  • Development, Adolescent

Keywords

  • Injury prevention
  • Adolescent development
  • Learner drivers
  • Crash risk reduction
  • Novice drivers
  • Risky Driving
  • Teens
03

In context

Risk Reduction Behavior

291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.

Browse Risk Reduction Behavior studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents ages 16-17 years old who reside in Pennsylvania
  • Have an active Pennsylvania learner's permit
  • Have \<30 hours of driving practice during permit phase
  • Have never taken an on-road licensing exam, in any state
  • Plan to get a license within the next 12 months in Pennsylvania
  • Plan to have access to a vehicle to drive after licensure
  • Have a personal cell phone and access to a smartphone/tablet/computer with internet access
  • Download and use the RoadReady app (only required for participants randomized to the behind-the-wheel training arm; optional for participants randomized to the online vehicle and driver safety and online driver skills training arms)
  • Are able to read/write in English
  • Provide /assent
  • Are not also taking part in another learner driver study

Exclusion criteria

Exclusion Criteria:

  • Non-Pennsylvania resident
  • Participants who do not pass the license exam will not be able to complete the post-license monitoring until the license is obtained
  • Enrolled in another learner driver study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
1,300 participants (estimated)

Study arms

  • Active comparator
    Active Control: Online Vehicle and Driver Safety Education

    Participants in this arm will receive care as usual, and also complete an online video training module on vehicle and driver safety, with a short quiz at the end to determine compliance. The training content will not teach driving skills, as in the other online driver training arm. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.).

    Behavioral: Online Vehicle and Driver Safety Education

  • Experimental
    Online Driver Skills Training

    Participants in the Online Driver Skills Training arm will complete an online driver skill training program known as Accelerated Curriculum to Create Effective Learning (ACCEL) for novice drivers. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.).

    Behavioral: Online Driver Skills Training

  • Experimental
    Behind-the-Wheel Driver Training

    Participants in the Behind-the-Wheel training arm will receive professional behind-the-wheel training course delivered in-person on the road by a local driving school instructor through our partnership with a local driving school Coastline Academy or licensed driver training schools subcontracted by Coastline Academy.

    Behavioral: Behind-the-Wheel Driver Training

Interventions

  • BehavioralOnline Vehicle and Driver Safety Education

    This online video education program provides education in vehicle and driver safety (e.g. vehicle maintenance, adjusting car seats and seatbelts). This online training will take up to 2 hours to complete and will have a short quiz at the end to determine compliance with this online training.

  • BehavioralOnline Driver Skills Training

    The online driver training is the Accelerated Curriculum to Create Effective Learning (ACCEL) is designed to enhance the ability to anticipate, recognize and respond to hazards and to maintain attention to the road. The training is delivered online via a computer and can be done from home or at a school or other site that has a computer with internet access. It requires up to two hours to complete, and will be hosted on a platform that will track progress and completion through the training (such as accuracy, duration in modules, time to complete) and a short quiz will be provided at the end to assess learning.

  • BehavioralBehind-the-Wheel Driver Training

    The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner Coastline Academy or licensed driver training schools subcontracted by Coastline Academy. The curriculum consists of 6 hours of training with assigned practice between lessons, and meets Pennsylvania and national standards. Post-lesson forms completed by the instructors will record adherence and consistency (intervention fidelity).

06

What researchers measure

Primary outcomes

  1. Hard Braking Events

    For Aim 1 and 3, the primary outcome is the number of hard braking events per 100 miles driven during the first 2 months post-licensure, as measured via the Way-to-Drive App.

    Time frame: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure, with primary outcome at 2 months post-licensure.

  2. Pass rate on the licensure exam

    The primary outcome in Aim 2 and 3 will be the pass rate on the first licensure exam attempt.

    Time frame: Measured at the time of the license examination, post-intervention (in about month 8-18).

Secondary outcomes

  1. Phone Use While Driving

    For Aim 1 and 3: minutes of handheld phone use per hour of driving, as measured via the Way-to-Drive App.

    Time frame: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure.

  2. Speeding

    For Aim 1 and 3: Proportion of drive time \>10 miles over the posted speed limit, as measured via the Way-to-Drive App.

    Time frame: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure.

  3. Crash Involvement

    For Aim 1 and 3: Self-reported involvement in crashes as a driver (binary yes/no) as captured by a question in our follow-up driver experience questionnaire: response options are 1) none; 2) one; 3) two; 4) more than 2. This item has been used in previous studies as part of the modified Driver Behavior Questionnaire (mDBQ).

    Time frame: Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24).

  4. Risky driving behavior

    For Aim 1 and 3: Risky Driving factor score as captured through self-reported responses on the modified driver behavior questionnaire, in which participants rate how often they engage in 11 different risk-taking behaviors while driving on a 6-point scale from "Never" to "Nearly all the time."

    Time frame: Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24).

  5. Virtual Driving Assessment performance

    For Aim 2 and 3: the class of driving behavior assessed via performance on a virtual driving assessment.

    Time frame: Measured at the time of the license examination, post-intervention (in about month 8-18).

  6. Change in Virtual Driving Assessment performance

    For Aim 2 and 3: the change in virtual driving assessment performance class assessed via performance on a virtual driving assessment pre- and post-intervention.

    Time frame: Measured at the time of the license examination, post-intervention (in about month 8-18).

  7. Number of license exam attempts

    For Aim 2 and 3: the number of attempts taken to pass the licensure exam.

    Time frame: Measured at the time of the license examination, post-intervention (in about month 8-18).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Walshe EA, Romer D, Elliott MR, Baxelbaum KS, Delgado MK, Ebert JP, Winston FK. A contemporary examination of the effect of driver training for reducing crash risk in novice adolescent drivers: protocol for the DRIVER study, a random assignment trial. Inj Epidemiol. 2025 Dec 1;13(1):2. doi: 10.1186/s40621-025-00645-2. PubMed 41327408 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Dec 2027, 40 months after the start.

Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 40 months is above that.

Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
May 14, 2024
StartActual
Aug 8, 2024
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Apr 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06413927
Responsible party
Sponsor
First posted
May 14, 2024
Start date
Aug 8, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Thomas Seacrist, MBE
Contact
seacrist@chop.edu
267-425-1547
Jamillah T Millner, MPH
Contact
millnerj@chop.edu
267-425-0375
Thomas Seacrist, MBE
principal investigator · Children's Hospital of Philadelphia
Flaura Winston, MD, PhD
principal investigator · Children's Hospital of Philadelphia
Dan Romer, PhD
principal investigator · Children's Hospital of Philadelphia/University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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