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Clinical Trials/NCT05608018
NCT05608018CompletedNot Applicable

A Novel Distracted Driving Prevention Technology Phase II

Minnesota HealthSolutions2 sites in 1 country500 target enrollmentStarted: June 26, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
500
Locations
2
Primary Endpoint
Changes in frequency of smartphone use while driving

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

Participants will be randomly assigned to the intervention/Bluetooth group, intervention/non-Bluetooth group, control/Bluetooth group, or control/non-Bluetooth group upon enrollment in the study. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.

Eligibility Criteria

Ages
16 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control Bluetooth

Other

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.

Intervention: Control Bluetooth (Other)

Intervention Bluetooth

Other

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.

Intervention: Intervention Bluetooth (Other)

Control non-Bluetooth

Other

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.

Intervention: Control non-Bluetooth (Other)

Intervention non-Bluetooth

Other

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.

Intervention: Intervention non-Bluetooth (Other)

Outcomes

Primary Outcomes

Changes in frequency of smartphone use while driving

Time Frame: 3 weeks

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.

Secondary Outcomes

  • Changes in frequency of self-reported smartphone use while driving(3 weeks)
  • Changes in frequency of text messages sent to Bluetooth device users(3 weeks)
  • Acceptability and Usability of the App(3 weeks)

Investigators

Sponsor
Minnesota HealthSolutions
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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