Behind the Wheel (BTW) Smartphone Application (BTW)

September 9, 2026 updated by: Motao Zhu

Behind the Wheel (BTW) Smartphone Application: Utilizing Technology to Quantify Driving Behaviors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project will assess the feasibility and preliminary efficacy of an app (BTW) to quantify driving behaviors and promote safe driving in adolescents who are beginning their learner period of licensure. 90 teens and their corresponding parents/guardians will be randomized into one of three study groups. Researchers aim to test the feasibility of the BTW app on acceptance and retention, evaluate the preliminary efficacy of the BTW app with a teen-parent dyad intervention on driving performance after using the BTW app for six months, and investigate the long-term effects of the BTW app intervention on driving performance and safety attitudes among teens.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BTW app with reward-based feedback
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
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).
Behavioral: BTW app with situational supervised driving practice
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.
Experimental: BTW app with situational supervised driving practice
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
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.
Sham Comparator: Sham BTW app
Teens will install the sham BTW app with driving performance tracking only.
Behavioral: Sham BTW app
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High-risk driving events
Time Frame: Baseline to 6 months post randomization
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speeding and near-crash events
Time Frame: Baseline to 6 months post randomization
Instances of speeding and number of near crashes and crashes per 1,000 miles driven. Higher numbers signify more near-crash events.
Baseline to 6 months post randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported high risk driving behaviors
Time Frame: 18-month study period
Self-reported frequency of high risk driving behaviors including speeding, distracted driving and driving under the influence of alcohol or drugs.
18-month study period
Self-reported driving safety attitudes
Time Frame: 18-month study period
The distribution of attitudes towards traffic safety behaviors, including speeding, distracted driving, and driving under the influence of alcohol or drugs, measured through self-report on 4-point Likert scales.
18-month study period
Self-reported traffic violations
Time Frame: 18-month study period
The number of traffic violations, including speeding, intoxicated driving, and distracted driving, measured through self-report on a questionnaire.
18-month study period
Police-reported traffic violations
Time Frame: 18-month study period
Number of police-reported crashes and traffic violations. Higher numbers signify more crashes and violations.
18-month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Motao Zhu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Motao Zhu, MD, MS, PhD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002565
  • FP00001219 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings