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Distracted Driving App Study for Teens and Parents/Caregivers

NCT ID: NCT04177524

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2021-08-31

Brief Summary

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The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application

Detailed Description

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This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving. Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver. The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.

Conditions

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Distracted Driving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study will utilize a crossover design with randomized assignment to three study arms to allow for comparison of app modes within drivers as each driver will act as their own control. The three app modes are: Background Mode (app runs in background and participants do not lock/unlock the phone), Manual Mode (participants manually unlock the phone), and Auto-Detect Mode (participants are automatically locked out of their phone if their phone camera detects them to be a driver or are automatically allowed to use their phone if the camera detects them to be a passenger).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants are aware of the differences between the app modes, and that the order in which they test out the different app modes is randomly assigned to them. The study team is not blinded to which study arm participants are assigned to.

Study Groups

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Arm 1

Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).

Group Type EXPERIMENTAL

Manual Mode

Intervention Type DEVICE

In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.

Auto-Detect Mode

Intervention Type DEVICE

In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Arm 2

Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.

Group Type EXPERIMENTAL

Manual Mode

Intervention Type DEVICE

In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.

Auto-Detect Mode

Intervention Type DEVICE

In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Arm 3

Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.

Group Type EXPERIMENTAL

Background Mode

Intervention Type DEVICE

The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.

Auto-Detect Mode

Intervention Type DEVICE

In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Interventions

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Background Mode

The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.

Intervention Type DEVICE

Manual Mode

In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.

Intervention Type DEVICE

Auto-Detect Mode

In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Intervention Type DEVICE

Other Intervention Names

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Mode 1 Mode 2 Mode 3

Eligibility Criteria

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Inclusion Criteria

* Licensed teen drivers 16 years to 18 years and one parent/caregiver
* Teen and parent/caregiver are both Android smartphone users
* Teen and parent/caregiver both drive a minimum of 2 days per week

Exclusion Criteria

* Non-fluency in written or spoken English
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minnesota HealthSolutions

INDUSTRY

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Curry, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Sara Seifert, MPH

Role: PRINCIPAL_INVESTIGATOR

Minnesota HealthSolutions

Locations

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Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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19-016717

Identifier Type: -

Identifier Source: org_study_id