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NCT04317664: projectDRIVE

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

Completed Phase 3 Results posted Last updated 23 February 2026
What this trial tests

Phase 3 trial testing In-vehicle device in Drive in 240 participants. Completed in 31 December 2025.

Timeline
28 September 2020
Primary endpoint
31 December 2024
31 December 2025

Quick facts

Lead sponsorGinger Yang
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment240
Start date28 September 2020
Primary completion31 December 2024
Estimated completion31 December 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ginger Yang

Who can join

Adults 16 to 17, any sex, with Drive or Recidivism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Risky Driving Events Primary · Six months/study period

Risky driving events are continuously monitored for teens (240) across all three groups using an in-vehicle device and smartphone app. The system automatically detects and records driving events, including hard braking (≤ -0.45 g-force) sudden acceleration (\> 0.35 g-force), speeding (\>10 miles over the posted speed limit), and speed \>75 mph. Event rates are calculated as the number of risky driving events per 1,000 miles driven.

GroupValue95% CI
Control Group101.3± 140.4
Feedback Only Group106.2± 108.6
Feedback and Parent Communication Group77.7± 89.2
Unsafe Behaviors Primary · Six months/study period

Unsafe driving behaviors among teens (N = 240) are continuously monitored across all three study groups using an in-vehicle device and a smartphone app. The system automatically records behaviors such as speeding, and seatbelt nonuse (for selected vehicle makes and model years only), as well as the distance traveled while these behaviors occur. Unsafe behavior rates are calculated as the number of miles involving an unsafe behavior per 1,000 miles driven. Survey data supplement these measures by capturing self-reported distracted driving and seatbelt use for vehicles that are not fully compati

Proportion of miles driven above the speeding threshold per trip
GroupValue95% CI
Control Group0.19± 0.3
Feedback Only Group0.19± 0.3
Feedback and Parent Communication Group0.16± 0.3
Proportion of miles driven without a seatbelt
GroupValue95% CI
Control Group0.09± 0.3
Feedback Only Group0.12± 0.3
Feedback and Parent Communication Group0.07± 0.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group
Serious: 0/80 (0%)
Deaths: 0/80
Feedback Only Group
Serious: 0/80 (0%)
Deaths: 0/80
Feedback and Parent Communication Group
Serious: 0/80 (0%)
Deaths: 0/80
Other adverse events (1 terms — click to expand)

ReactionSystemControl GroupFeedback Only GroupFeedback and Parent Commun…
Teen Vehicle CrashSocial circumstances

Data from ClinicalTrials.gov NCT04317664 adverse events section.

Sponsor's own description

The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. ProjectDRIVE: study protocol for a randomized controlled trial to improve driving practices of high-risk teen drivers with a traffic violation.
    Yang J, Peek-Asa C, Zhang Y, Hamann C, et al · · 2024 · cited 1× · PMID 38553746 · DOI 10.1186/s40621-024-00494-5
  2. In-Vehicle Feedback With or Without Parent Communication Training and Teenage Driving Behaviors: A Randomized Clinical Trial.
    Yang J, Zhang Y, Alshaikh E, Schneider H, et al · · 2026 · PMID 42030047 · DOI 10.1001/jamanetworkopen.2026.8631

Verify or expand the search:

Other recruiting trials for Drive

Currently open trials in the same condition.

Other Ginger Yang trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04317664.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing