Preventing Distracted Driving Phase II

Study Overview
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Brief Summary
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The purpose of the study is to determine the efficacy of a smartphone app in reducing mobile phone use while driving among teens and parents. Prior to sending a message, the smartphone app informs a potential message sender that the recipient is driving.

Detailed Description
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The primary objective of this study is to determine whether the app reduces (1) smartphone communication sent from parent to teen while the teen is driving; and (2) smartphone communication sent from teen while the teen is driving. The secondary objectives are to: Determine whether the app reduces smartphone communication sent from teen to parent while parent is driving; Evaluate the acceptability of the app among parents and teens; and determine the relationship between individual differences (demographics, typical smartphone use, driving history, risk perception) and the app's efficacy.

Official Title
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A Novel Distracted Driving Prevention Technology Phase II

Conditions
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Distracted Driving

Intervention / Treatment
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* Other: Intervention Bluetooth
* Other: Intervention non-Bluetooth
* Other: Control Bluetooth
* Other: Control non-Bluetooth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teen participants: 16 to 19 years of age Hold a valid driver's license Own an iPhone Drive at least 3 days per week Parent/caregiver participants: 18 to 75 years of age Hold a valid driver's license Own an iPhone Drive at least 3 days per week Exclusion Criteria: Teen participants: 1. Non-fluency in written or spoken English Parent/caregiver participants: 1. Non-fluency in written or spoken English

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized control trial with 2 arms, and 4 possible randomization groups (intervention/Bluetooth, intervention/non-Bluetooth, control/Bluetooth, and control/non-Bluetooth). The control group will receive the control condition, during which the app monitors driving but the intervention feature is not enabled, and the intervention group will receive the intervention condition during which the intervention feature is enabled. Both groups will self-report their smartphone communication while driving via periodic surveys. Participants randomized to receive a Bluetooth device will keep the device in their primary vehicle for the duration of the study. This device will collect outgoing text date and time from their dyad partner enrolled in the study. Non-Bluetooth participants will not receive the device.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Bluetooth<br>Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study. | Other: Control Bluetooth<br>* Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with some features turned off.<br>|
| Other: Intervention Bluetooth<br>Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study. | Other: Intervention Bluetooth<br>* Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with all features turned on.<br>|
| Other: Control non-Bluetooth<br>Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device. | Other: Control non-Bluetooth<br>* Participants will not receive a Bluetooth device, and will use the app with some features turned off.<br>|
| Other: Intervention non-Bluetooth<br>Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device. | Other: Intervention non-Bluetooth<br>* Participants will not receive a Bluetooth device, and will use the app with all features turned on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in frequency of smartphone use while driving | Changes in smartphone communication sent from parent to teen while the teen is driving and changes in smartphone communication sent from teen while the teen is driving. Frequency of smartphone use is recorded by the app among the three app modes. Within-driver smartphone use over the 3-week study period is compared as the app modes change. Smartphone use between driver groups will also be compared. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes 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, each week for 3 weeks. 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, sent a text, and read a text while driving. | 3 weeks | 
| Acceptability and Usability of the App | Participant assessment of accessibility and usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at the end of week 3, post-intervention. 8 items in the survey ask participants about accessibility and usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility and 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. | 3 weeks | 
| Changes in frequency of text messages sent to Bluetooth device users | Bluetooth device users will have received text message date and time collected via the Bluetooth device. This device will only collect data from the dyad partner enrolled in the study with them. This data will be used to validate the self report data collected from all participants. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile phone use while driving