Distracted DrivingIDDNCT04177524
Distracted Driving App Study for Teens and Parents/Caregivers
A study testing Background Mode, Manual Mode and Auto-Detect Mode in people with Distracted Driving, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distracted Driving
- What is being tested?
- Background Mode, Manual Mode and Auto-Detect Mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 31 Aug 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-fluency in written or spoken English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia Roberts Center for Pediatric Research
Philadelphia, Pennsylvania, 19146
About this study
Official title: An Informatics Approach to Preventing Distracted Driving
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
Read the detailed description
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.
- Conditions
- Distracted Driving
- Being tested
- Background Mode, Manual Mode, Auto-Detect Mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Background ModeDevice
Also called Mode 1
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.
Manual ModeDevice
Also called Mode 2
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.
Auto-Detect ModeDevice
Also called Mode 3
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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). Receives: Device: Manual Mode; Device: Auto-Detect Mode |
| Arm 2 | Experimental | Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks. Receives: Device: Manual Mode; Device: Auto-Detect Mode |
| Arm 3 | Experimental | Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks. Receives: Device: Background Mode; Device: Auto-Detect Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2, 4, 6, and post-intervention at Week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Post-Intervention at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start23 Jan 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distracted DrivingStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota HealthSolutions
- Responsible party
- Sponsor
- Investigators
- Allison Curry, PhD, MPH, Principal investigator, Children's Hospital of PhiladelphiaSara Seifert, MPH, Principal investigator, Minnesota HealthSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177524
- Sponsor's protocol ID
- 19-016717
- Acronym
- IDD
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2019
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 studies without first obtaining CHOP 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).
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Informatics Approach to Preventing Distracted Driving
- ClinicalTrials.gov ID
- NCT04177524
- Acronym / sponsor ID
- IDD / 19-016717
- Conditions
- Distracted Driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Minnesota HealthSolutions
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 26 Nov 2019 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Manual Mode, Device: Auto-Detect ModeParticipants 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). |
| Arm 2 | Experimental | Device: Manual Mode, Device: Auto-Detect ModeParticipants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks. |
| Arm 3 | Experimental | Device: Background Mode, Device: Auto-Detect ModeParticipants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Background ModeAlso: Mode 1The 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. | Device | Arm 3 |
| Manual ModeAlso: Mode 2In 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. | Device | Arm 1, Arm 2 |
| Auto-Detect ModeAlso: Mode 3In 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. | Device | Arm 1, Arm 2, Arm 3 |
Primary outcome
Change in frequency of smartphone use while driving
Time frame: Week 2, 4, 6, and post-intervention at Week 8
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.
3 secondary outcomes
Change in frequency of self-reported smartphone use while driving
Time frame: Weeks 2, 4, 6, and Post-Intervention at Week 8
Participant acceptability of the smartphone App: survey
Time frame: Post-Intervention at Week 8
Participant usability of the smartphone app: survey
Time frame: Post-Intervention at Week 8
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 19 Nov 2021.
- 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 studies without first obtaining CHOP 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.
Allison Curry, PhD, MPH principal investigator
Children's Hospital of Philadelphia
Sara Seifert, MPH principal investigator
Minnesota HealthSolutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Background Mode, Manual Mode and Auto-Detect Mode in people with Distracted Driving, run by Children's Hospital of Philadelphia 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 3 inclusion and 1 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 19 Nov 2021. 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?
Change in frequency of smartphone use while driving (time frame: Week 2, 4, 6, and post-intervention at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.