Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

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.

Study Overview

• Status: Recruiting
• Conditions: Cell Phone Use; Automobile Driving
• Intervention / Treatment: Behavioral: Commercial Cellphone-Blocking App (Active); Behavioral: Driving Mode

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Motao Zhu, MD,MS,PhD; Phone Number: (614)-355-6687; Email: motao.zhu@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Motao Zhu, MD,MS,PhD; Phone Number: 614-355-6687; Email: motao.zhu@nationwidechildrens.org
      • Principal Investigator: Motao Zhu, MD,MS,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 3-4 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Commercial cell-phone blocking app installed on smartphone, but app will be inactive.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calling, texting, and handheld cell phone use while driving	Number of calling occurrences, texting occurrences, and handheld phone use occurrences, per 1,000 miles driven. Higher numbers signify more calling, texting, and handheld cell phone use.	5-month intervention period
High-risk driving events	Total number of high-risk driving events (e.g., hard-braking, sudden acceleration, swerving) per 1,000 miles driven. Higher numbers signify more high-risk driving events.	5-month intervention period

Collaborators and Investigators

• Sponsor: Motao Zhu
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Iowa; Ohio State University
• Investigators: Principal Investigator: Motao Zhu, Abigail Wexner Research Institute at Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Driving; Texting; Mobile Technology
• Other Study ID Numbers: STUDY00001601; R01HD102439 (U.S. NIH Grant/Contract)

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