Distracted DrivingNCT05608018
Preventing Distracted Driving Phase II
A study testing Intervention Bluetooth and Intervention non-Bluetooth in people with Distracted Driving, run by Minnesota HealthSolutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Distracted Driving
- What is being tested?
- Intervention Bluetooth and Intervention non-Bluetooth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 18 to 75 years of age
- Hold a valid driver's license
- Own an iPhone
- Drive at least 3 days per week
Who cannot join
- Teen participants:
- 1. Non-fluency in written or spoken English
- Parent/caregiver participants:
- 1. Non-fluency in written or spoken English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Novel Distracted Driving Prevention Technology Phase II
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.
Read the 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.
- Conditions
- Distracted Driving
- Being tested
- Intervention Bluetooth, Intervention non-Bluetooth, Control Bluetooth, Control non-Bluetooth
- Keywords
- mobile phone use while driving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 non-BluetoothOther
Participants will not receive a Bluetooth device, and will use the app with all features turned on.
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 non-BluetoothOther
Participants will not receive a Bluetooth device, and will use the app with some features turned off.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Intervention non-Bluetooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start26 Jun 2023
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Distracted DrivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota HealthSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Sara Seifert, MPH, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608018
- Sponsor's protocol ID
- 21-018977
- Status last verified
- May 2025
- First submitted
- 31 Oct 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
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.
PubMed 21545856Redelmeier 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.
PubMed 9017937National Highway Traffic Safety Administration. Research Note: Distracted Driving 2015. Washington, DC; 2017. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812381.
Ehsani J, Li K, Simons-Morton BG. Teenage Drivers Portable Electronic Device Use While Driving. In: ; 2015:219-225. doi:10.17077/drivingassessment.1575
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.
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.
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.
PubMed 16553070Hafetz 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.
PubMed 20728605LaVoie 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.
PubMed 26562672McDonald 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.
PubMed 26436243
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Distracted Driving Prevention Technology Phase II
- ClinicalTrials.gov ID
- NCT05608018
- Acronym / sponsor ID
- 21-018977
- Conditions
- Distracted Driving
- Keywords
- mobile phone use while driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Minnesota HealthSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Bluetooth | Other | Other: Control BluetoothParticipants 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 Bluetooth | Other | Other: Intervention BluetoothParticipant 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. |
| Control non-Bluetooth | Other | Other: Control non-BluetoothParticipants 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 non-Bluetooth | Other | Other: Intervention non-BluetoothParticipant 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 16 to 19 years of age
- Hold a valid driver's license
- Own an iPhone
- Drive at least 3 days per week
- 18 to 75 years of age
Key exclusion criteria (4 listed)
- 1. Non-fluency in written or spoken English
- 1. Non-fluency in written or spoken English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention BluetoothParticipants will receive a Bluetooth device to use for the duration of the study, and will use the app with all features turned on. | Other | Intervention Bluetooth |
| Intervention non-BluetoothParticipants will not receive a Bluetooth device, and will use the app with all features turned on. | Other | Intervention non-Bluetooth |
| Control BluetoothParticipants will receive a Bluetooth device to use for the duration of the study, and will use the app with some features turned off. | Other | Control Bluetooth |
| Control non-BluetoothParticipants will not receive a Bluetooth device, and will use the app with some features turned off. | Other | Control non-Bluetooth |
Primary outcome
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.
3 secondary outcomes
Changes in frequency of self-reported smartphone use while driving
Time frame: 3 weeks
Acceptability and Usability of the App
Time frame: 3 weeks
Changes in frequency of text messages sent to Bluetooth device users
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- BackgroundDurbin 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: PubMed 21545856Curry 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.
- Background: PubMed 9017937Redelmeier 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.
- BackgroundNational Highway Traffic Safety Administration. Research Note: Distracted Driving 2015. Washington, DC; 2017. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812381.
- BackgroundEhsani J, Li K, Simons-Morton BG. Teenage Drivers Portable Electronic Device Use While Driving. In: ; 2015:219-225. doi:10.17077/drivingassessment.1575
- BackgroundInsurance 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.
- BackgroundHow 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: PubMed 16553070Pradhan 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.
- Background: PubMed 20728605Hafetz 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.
- Background: PubMed 26562672LaVoie 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.
- Background: PubMed 26436243McDonald 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.
- Individual participant dataSharing planned: Yes. 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).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Seifert, MPH principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Bluetooth and Intervention non-Bluetooth in people with Distracted Driving, run by Minnesota HealthSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency of smartphone use while driving (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608018, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.