NCT03639753

Brief Summary

The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,216

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2021Aug 2026

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
3 years until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

April 30, 2026

Status Verified

October 1, 2025

Enrollment Period

4.6 years

First QC Date

August 17, 2018

Last Update Submit

April 29, 2026

Conditions

Automobile Accident

Keywords

teen driver safetyinjury prevention

Outcome Measures

Primary Outcomes (1)

  • Police-reported motor vehicle crashes

    Time to first motor vehicle crash

    Baseline to 12 months after licensure

Study Arms (2)

Parent-Teen Intervention

EXPERIMENTAL

Parent health coaching session and supportive materials, teen on road driver assessment with feedback.

Behavioral: Parent-Teen Intervention

Usual Practice

OTHER
Other: Usual Practice

Interventions

Parent-Teen InterventionBEHAVIORAL

Parent health coaching and resources + teen on-road driver experience + safe driving eLearning Modules

Parent-Teen Intervention
Usual PracticeOTHER

Standard care for teens who get licensed in the state of PA

Usual Practice

Eligibility Criteria

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

You may qualify if:

  • Teens between 16 and 17 years and 4 months (17.33 years) of age
  • Pennsylvania state learner's permits
  • Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
  • Self-report of less than 10 hours of behind-the-wheel driving experience.
  • Teen and parent/caregiver fluent in written and spoken English
  • Access to at least one practice vehicle
  • Email address and internet access to complete study procedures

You may not qualify if:

  • Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
  • Teens with pervasive developmental delays
  • Have a sibling enrolled in this study
  • Enrolled in other teen driving studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Hafetz J, McDonald CC, Long DL, Ford CA, Mdluli T, Weiss A, Felkins J, Wilson N, MacDonald B. Promoting transportation safety in adolescence: the drivingly randomized controlled trial. BMC Public Health. 2023 Oct 17;23(1):2020. doi: 10.1186/s12889-023-16801-6.

    PMID: 37848929DERIVED

Study Officials

  • Leann Long, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Catherine McDonald, PhD, RN, FAAN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Jessica Mirman, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

August 18, 2021

Primary Completion

March 18, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 30, 2026

Record last verified: 2025-10

Locations

US(1)