NCT06413927

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

April 24, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

April 24, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

Injury preventionAdolescent developmentLearner driversCrash risk reductionNovice driversRisky DrivingTeens

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

  • 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.

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

Secondary Outcomes (7)

  • Phone Use While Driving

    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.

  • Speeding

    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.

  • Crash Involvement

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

  • Risky driving behavior

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

  • Virtual Driving Assessment performance

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

  • +2 more secondary outcomes

Study Arms (3)

Active Control: Online Vehicle and Driver Safety Education

ACTIVE COMPARATOR

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

Online Driver Skills Training

EXPERIMENTAL

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

Behind-the-Wheel Driver Training

EXPERIMENTAL

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.

Behavioral: Behind-the-Wheel Driver Training

Interventions

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.

Active Control: Online Vehicle and Driver Safety Education

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.

Online Driver Skills Training

The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner 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).

Behind-the-Wheel Driver Training

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 informed consent/assent
  • Are not also taking part in another learner driver study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Risk Reduction BehaviorWounds and Injuries

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elizabeth A Walshe, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Flaura Winston, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Dan Romer, PhD

    Children's Hospital of Philadelphia/University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Walshe, PhD

CONTACT

Jamillah T Millner, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The research staff who are unblinded will deliver the electronic surveys and cognitive battery (which is automatically scored) at baseline before participants are randomly assigned to an arm. The primary outcome variables are automatically scored, thus blindly to intervention arm. The Virtual Driving Assessment is a self-guided tool and is automatically scored. The smartphone app automatically records hard braking events and other behaviors without knowledge of intervention arm. Licensing tests will be conducted by state-sanctioned licensing examiners who will be blinded to which arm the participant is in (per state mandate).
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 14, 2024

Study Start

August 8, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations