Distracted Driving App Study for Teens and Parents/Caregivers

Study Overview
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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.

Official Title
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An Informatics Approach to Preventing Distracted Driving

Conditions
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Distracted Driving

Intervention / Treatment
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* Device: Background Mode
* Device: Manual Mode
* Device: Auto-Detect Mode


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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). | Device: Manual Mode<br>* 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.<br>* Other names: Mode 2;Device: Auto-Detect Mode<br>* 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.<br>* Other names: Mode 3;|
| Experimental: Arm 2<br>Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks. | Device: Manual Mode<br>* 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.<br>* Other names: Mode 2;Device: Auto-Detect Mode<br>* 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.<br>* Other names: Mode 3;|
| Experimental: Arm 3<br>Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks. | Device: Background Mode<br>* 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.<br>* Other names: Mode 1;Device: Auto-Detect Mode<br>* 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.<br>* Other names: Mode 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of smartphone use while driving | Frequency of smartphone use is recorded by the LifeSaver app among the three app modes. Within-driver smartphone use over the 8-week study period is compared as the app modes change. | Week 2, 4, 6, and post-intervention at Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of self-reported smartphone use while driving | The change in self-reported smartphone use while driving will be assessed using the same within-driver and between-driver comparisons as the primary outcome measure. Self-reported smartphone use is collected through 10 items on a participant survey that is completed at enrollment, Weeks 2, 4, 6 and post-intervention at Week 8. Participants report how many days during the previous 2 weeks (0-14) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving. Participants also report how many times per day (free text, any number greater than or equal to 0) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving. There is no overall self-reported smartphone use score for these survey items. | Weeks 2, 4, 6, and Post-Intervention at Week 8 | 
| Participant acceptability of the smartphone App: survey | Participant assessment of accessibility will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at Week 8, post-intervention. 8 items in the survey ask participants about accessibility of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility of the app through open-ended questions, where participants are able to enter free text. There is no overall score for these survey items. | Post-Intervention at Week 8 | 
| Participant usability of the smartphone app: survey | Participant assessment of usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at Week 8, post-intervention. 8 items in the survey ask participants about usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about usability of the app through open-ended questions, where participants are able to enter free text. There is no overall score for these survey items. | Post-Intervention at Week 8 |