Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

NCT ID: NCT05163119

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2026-06-30

Brief Summary

The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.

Detailed Description

For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.

Conditions

Cell Phone Use; Automobile Driving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

Commercial cell-phone blocking app installed on smartphone, but app will be inactive.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Commercial Cellphone-Blocking App

Commercial cellphone-blocking app that blocks handheld cellphone use while driving, but allows emergency calls and phone use after pressing the passenger button will be installed on smartphone.

Group Type: EXPERIMENTAL

Commercial Cellphone-Blocking App (Active)

Intervention Type: BEHAVIORAL

The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone.

Driving Mode

Driving mode blocks handheld phone use while driving or facilitates hands free use (exact functionality dependent on smartphone type and service provider).This group will also have the commercial cell-phone blocking app installed on smartphone, but app will be inactive.

Group Type: EXPERIMENTAL

Driving Mode

Intervention Type: BEHAVIORAL

Apple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider).

Interventions

Commercial Cellphone-Blocking App (Active)

The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone.

Intervention Type: BEHAVIORAL

Driving Mode

Apple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults 18-24 years of age at time of recruitment
• Must have ownership and exclusive access to a passenger vehicle
• Must have car insurance with at least state-minimum coverage
• Must live in Greater Columbus (Ohio) area
• Must drive at least 2 days a week on average
• Must have functioning iPhone or Android smartphone with an active phone service account (Ex: Verizon, AT&T, etc.)
• Must self-report handheld calling or texting while driving (≥ 1 time/week)
• Must not be enrolled in another driving-related research study during the study period.
• Must be willing to be randomized and comply with study requirements
• Must have no plans to change cellphones or vehicles in next 6 months or agree to transfer FleetSafer app/DriveCam if they change cellphones or vehicles
• Must speak and read English

Exclusion Criteria

• Drivers under 18 years of age
• Drivers holding learner's permits
• Drivers who share a vehicle with a family member or others
• Infrequent drivers (Drive 2 days a week or less)
• Participants from the pilot R21 project
• Current users of a cellphone-blocking app or driving mode who do not agree to uninstall/de-activate the app for the duration of participation in the study
• Current users of a car insurance monitoring device (physical device or app)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

Motao Zhu

OTHER

Sponsor Role: lead

Responsible Party

Motao Zhu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Motao Zhu

Role: PRINCIPAL_INVESTIGATOR

Abigail Wexner Research Institute at Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Motao Zhu, MD,MS,PhD

Role: CONTACT

motao.zhu@nationwidechildrens.org

(614)-355-6687

Facility Contacts

Motao Zhu, MD,MS,PhD

Role: primary

motao.zhu@nationwidechildrens.org

(614)-355-6687

Other Identifiers

R01HD102439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001601

Identifier Type: -

Identifier Source: org_study_id