NCT05608018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

October 31, 2022

Last Update Submit

May 2, 2025

Conditions

Distracted Driving

Keywords

mobile phone use while driving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in frequency of self-reported smartphone use while driving

    3 weeks

  • Acceptability and Usability of the App

    3 weeks

  • Changes in frequency of text messages sent to Bluetooth device users

    3 weeks

Study Arms (4)

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.

Other: Control Bluetooth

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.

Other: Intervention Bluetooth

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.

Other: Control non-Bluetooth

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.

Other: Intervention non-Bluetooth

Interventions

Intervention BluetoothOTHER

Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with all features turned on.

Intervention Bluetooth
Intervention non-BluetoothOTHER

Participants will not receive a Bluetooth device, and will use the app with all features turned on.

Intervention non-Bluetooth
Control BluetoothOTHER

Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with some features turned off.

Control Bluetooth
Control non-BluetoothOTHER

Participants will not receive a Bluetooth device, and will use the app with some features turned off.

Control non-Bluetooth

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teen participants:
  • to 19 years of age
  • Hold a valid driver's license
  • Own an iPhone
  • Drive at least 3 days per week
  • Parent/caregiver participants:
  • to 75 years of age
  • Hold a valid driver's license
  • Own an iPhone
  • Drive at least 3 days per week

You may not qualify if:

  • Teen participants:
  • \. Non-fluency in written or spoken English
  • Parent/caregiver participants:
  • \. Non-fluency in written or spoken English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

  • Durbin DR, Curry AE, García-España JF, et al. Miles to Go: Monitoring Progress in Teen Driver Safety. The Children's Hospital of Philadelphia Research Institute and State Farm Insurance Companies; 2012. http://www.teendriversource.org/tools/support_gov/detail/205.

    BACKGROUND

  • Curry AE, Hafetz J, Kallan MJ, Winston FK, Durbin DR. Prevalence of teen driver errors leading to serious motor vehicle crashes. Accid Anal Prev. 2011 Jul;43(4):1285-90. doi: 10.1016/j.aap.2010.10.019. Epub 2010 Nov 19.

    PMID: 21545856BACKGROUND

  • Redelmeier DA, Tibshirani RJ. Association between cellular-telephone calls and motor vehicle collisions. N Engl J Med. 1997 Feb 13;336(7):453-8. doi: 10.1056/NEJM199702133360701.

    PMID: 9017937BACKGROUND

  • National Highway Traffic Safety Administration. Research Note: Distracted Driving 2015. Washington, DC; 2017. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812381.

    BACKGROUND

  • Ehsani J, Li K, Simons-Morton BG. Teenage Drivers Portable Electronic Device Use While Driving. In: ; 2015:219-225. doi:10.17077/drivingassessment.1575

    BACKGROUND

  • Insurance Institute for Highway Safety, Highway Loss Data Institute. Fatality Facts 2017: Teenagers. Insurance Institute for Highway Safety (IIHS). https://www.iihs.org/topics/fatality-statistics/detail/teenagers. Published 2018. Accessed August 12, 2019.

    BACKGROUND

  • How Teens Use Media: A Nielsen Report on the Myths and Realities of Teen Media Trends.; 2009. http://blog.nielsen.com/nielsenwire/reports/nielsen_howteensusemedia_june09.pdf.

    BACKGROUND

  • Pradhan AK, Hammel KR, DeRamus R, Pollatsek A, Noyce DA, Fisher DL. Using eye movements to evaluate effects of driver age on risk perception in a driving simulator. Hum Factors. 2005 Winter;47(4):840-52. doi: 10.1518/001872005775570961.

    PMID: 16553070BACKGROUND

  • Hafetz JS, Jacobsohn LS, Garcia-Espana JF, Curry AE, Winston FK. Adolescent drivers' perceptions of the advantages and disadvantages of abstention from in-vehicle cell phone use. Accid Anal Prev. 2010 Nov;42(6):1570-6. doi: 10.1016/j.aap.2010.03.015. Epub 2010 Jul 2.

    PMID: 20728605BACKGROUND

  • LaVoie N, Lee YC, Parker J. Preliminary research developing a theory of cell phone distraction and social relationships. Accid Anal Prev. 2016 Jan;86:155-60. doi: 10.1016/j.aap.2015.10.023. Epub 2015 Nov 10.

    PMID: 26562672BACKGROUND

  • McDonald CC, Sommers MS. Teen Drivers' Perceptions of Inattention and Cell Phone Use While Driving. Traffic Inj Prev. 2015;16 Suppl 2(0):S52-8. doi: 10.1080/15389588.2015.1062886.

    PMID: 26436243BACKGROUND

Study Officials

  • Sara Seifert, MPH

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

June 26, 2023

Primary Completion

July 23, 2024

Study Completion

July 23, 2024

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The study will comply with CHOP's data retention policy (A-3-9). All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data
Access Criteria
IRB approval, data use agreement

Locations

US(1)