Behind the Wheel (BTW) Smartphone Application

NCT05554614 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00002565FP00001219
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if a phone app can help the learning-to-drive process among teenagers and novice drivers.

Conditions

High-risk Driving Events

Outcome Measures

Primary Outcomes (1)

• High-risk driving events

  Number of high-risk driving events (harsh breaking, accelerating, and cornering events) per 1,000 miles driven. Higher numbers signify more high-risk driving events.

  Baseline to 6 months post randomization

Secondary Outcomes (1)

• Speeding and near-crash events

  Baseline to 6 months post randomization

Other Outcomes (4)

• Self-reported high risk driving behaviors

  18-month study period

• Self-reported driving safety attitudes

  18-month study period

• Self-reported traffic violations

  18-month study period

Study Arms (3)

BTW app with reward-based feedback

EXPERIMENTAL

Teens will install the BTW app with reward-based feedback. This tracks driving performance while providing individualized driving feedback using gamification concepts.

Behavioral: BTW app with reward-based feedback; Behavioral: BTW app with situational supervised driving practice

BTW app with situational supervised driving practice

EXPERIMENTAL

Teens will install the BTW app the same as the app with reward-based feedback in conjunction with a situational supervised driving practice intervention for teen-parent dyads.

Behavioral: BTW app with situational supervised driving practice

Sham BTW app

SHAM COMPARATOR

Teens will install the sham BTW app with driving performance tracking only.

Behavioral: Sham BTW app

Interventions

BTW app with reward-based feedback BEHAVIORAL

Teen drivers will be notified of their weekly driving performance via a driving safety score with information on the types of high-risk driving behaviors committed as well as progress on maintaining and/or improving weekly safe driving behaviors. Educational materials on different driving situations and scenarios associated with the high-risk driving behaviors (e.g. 90-second videos) will be provided for the driver to review at any point and time. Information on these driving behaviors and the education material will be provided via push notifications from the BTW app. Weekly leader boards will show the driver's driving safety score in comparison to other drivers of the same age. Consistently high driver safety scores in certain driving skill areas (e.g., cornering) and a total overall score above 70% of other users on that skill or total score will unlock gamification-based rewards (e.g., driving safety badges, driving safety score leader board, group challenges with winners).

BTW app with reward-based feedback

BTW app with situational supervised driving practice BEHAVIORAL

Teen drivers will be provided bi-weekly push-notifications from the BTW app notifying them of situational supervised driving practice activities that are to be completed during the assigned week. There are 12 situational supervised driving activities and six skill-building driving activities (Table 1). Skill-building sessions are assigned for off weeks during the first half of the six months (weeks 2-12), allowing for skills to be further developed when the situations are encountered for a second time (weeks 15-23). Parents will be prompted to directly log situational supervised and skill-building driving activities in the app after the session within the BTW app to obtain the module completion date and duration time.

BTW app with reward-based feedback; BTW app with situational supervised driving practice

Sham BTW app BEHAVIORAL

Teens will be provided links to passive education materials and information on car maintenance every week. They will not be given feedback on their driving performances.

Sham BTW app

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Teen participants must be between the ages of 15.5-17 years old at the time of enrollment
• Participants must have one parent and/or legal guardian who agrees to participate in the study.
• Participants' parents must possess car insurance with at least state-minimum coverage.
• Participants must be willing to fulfill the minimum requirements of the Ohio GDL system.
• Driver must complete a driver education class at a licensed driver training school with 24 hours of classroom or online instruction and 8 hours of driving time; driver must complete 50 hours of driving with at least 10 hours of night driving; driver must hold the permit for at least 6 months.
• Participants must have a functioning smartphone and active smartphone account compatible for the BTW app.
• To prevent any interference from another driving-related study, participants must agree not to enroll in other driving-related research/driving performance app during the study period.
• Participants must be willing to be randomized and comply with study requirements.
• Participants must speak and read English.
• Participants must be a US citizen or have permanent resident status.

You may not qualify if:

• \- Drivers younger than 15.5 will be excluded because Ohio does not issue a temporary instruction driving permit identification card (i.e., learner's driving permit) starting the GDL process until age 15.5.

Sponsors & Collaborators

• Motao Zhu: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Motao Zhu, MD, MS, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: September 26, 2022
• Study Start: February 19, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)