Teen DriversNCT02416713
Way to Safety Cellphone Blocking
A study testing Education Only in people with Teen Drivers and Motor Vehicle Accident, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking… Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Drivers, Motor Vehicle Accident
- What is being tested?
- Education Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2016to 24 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- High school student
- 16 or 17 at start of the study
- Have a valid driver's license
- Lives in parent's/guardian's home
- Drives to school
- Primarily drive one car
Show all 9Show fewer
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- Parent/guardian is willing to assist with installation
- Admit to texting while driving >1 time in the last 30 days
Who cannot join
- 1. Already uses a smartphone app or hardware device to limit cellphone use while driving
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Way to Safety: Cellphone Blocking Technology to Reduce Cellphone Use While Driving Among Teens
Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.
Read the detailed description
Motor vehicle crashes are the leading cause of death in teens in the United State and for drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones. Nearly 90% of teens expect a response to a text message within 5 minutes, and the compulsion to respond is stronger for messages from close social contacts. This suggests that behavioral-economic interventions such as immediate and frequent incentives are needed to offset the disutility caused by not being able to communicate by cellphone while driving. If proven to be effective, incentives could be scaled up via auto insurance discount contributions, school programs, and parental contributions.
- Conditions
- Teen Drivers, Motor Vehicle Accident
- Being tested
- Cellcontrol DriveID, Education Only
- Keywords
- Driving, Teens, Texting, Cellphone, DriveID, Motor vehicle accident
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellcontrol DriveIDDevice
Also called DriveID
Technology that blocks incoming and outgoing calls and texts.
Education OnlyOther
Also called Control
No active intervention, educational materials will be provided
| Study group | Role | What they receive |
|---|---|---|
| Education Only (Control) | Placebo comparator | The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Receives: Other: Education Only |
| Opt-in Blocking | Experimental | Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Receives: Device: Cellcontrol DriveID |
| Opt-out Blocking | Experimental | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Receives: Device: Cellcontrol DriveID |
| Opt-out Blocking with Notification | Experimental | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Receives: Device: Cellcontrol DriveID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Cellphone Unlocks
Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start13 Apr 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Teen DriversStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Catherine McDonald, PhD, RN, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416713
- Sponsor's protocol ID
- 14-11234
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2015
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Way to Safety: Cellphone Blocking Technology to Reduce Cellphone Use While Driving Among Teens
- ClinicalTrials.gov ID
- NCT02416713
- Acronym / sponsor ID
- 14-11234
- Conditions
- Teen Drivers, Motor Vehicle Accident
- Keywords
- Driving, Teens, Texting, Cellphone, DriveID, Motor vehicle accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.
Detailed description
Motor vehicle crashes are the leading cause of death in teens in the United State and for drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones. Nearly 90% of teens expect a response to a text message within 5 minutes, and the compulsion to respond is stronger for messages from close social contacts. This suggests that behavioral-economic interventions such as immediate and frequent incentives are needed to offset the disutility caused by not being able to communicate by cellphone while driving. If proven to be effective, incentives could be scaled up via auto insurance discount contributions, school programs, and parental contributions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Education Only (Control) | Placebo comparator | Other: Education OnlyThe Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. |
| Opt-in Blocking | Experimental | Device: Cellcontrol DriveIDParticipants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. |
| Opt-out Blocking | Experimental | Device: Cellcontrol DriveIDCellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. |
| Opt-out Blocking with Notification | Experimental | Device: Cellcontrol DriveIDCellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- High school student
- 16 or 17 at start of the study
- Have a valid driver's license
- Lives in parent's/guardian's home
- Drives to school
Key exclusion criteria (1 listed)
- 1. Already uses a smartphone app or hardware device to limit cellphone use while driving
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 |
|---|---|---|
| Cellcontrol DriveIDAlso: DriveIDTechnology that blocks incoming and outgoing calls and texts. | Device | Opt-in Blocking, Opt-out Blocking, Opt-out Blocking with Notification |
| Education OnlyAlso: ControlNo active intervention, educational materials will be provided | Other | Education Only (Control) |
Primary outcome
Change in Frequency of Cellphone Unlocks
Time frame: 6 weeks
Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Teen Drivers
Active, not recruiting
Transportation Safety in Adolescence
Automobile Accident
Active, not recruitingPhase 3
Teen Driving Translation Study (NIH)
Drive, Recidivism
Recruiting
Driver Education Research Study
Risk Reduction Behavior, Injuries
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.
Catherine McDonald, PhD, RN principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Only in people with Teen Drivers and Motor Vehicle Accident, run by Children's Hospital of Philadelphia at 2 sites 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 9 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cellphone Unlocks (time frame: 6 weeks). 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 28 Feb 2019.