Teen DriversNCT02923271
Promoting Intrafamily Accountability for Reducing Cellphone Use While Driving in Adults and Their Teen Children
A study of Teen Drivers and Motor Vehicle Accidents, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
Research participants and their parents will be recruited to take part in a randomized control trial. Participants' and their parents' cellphone use will be observed during an initial baseline period. 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 Accidents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2016to 16 Nov 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
- Both parent and teen will be enrolled together as a pair
- Teen:
- Is a high school student (age 16 or 17 at start of the study)
- Holds a valid driver's license
- Lives in parent/guardian's home
- Primarily drives one car
Show all 15Show fewer
- Drives an average of 4 or more trips per week
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- Admits to texting while driving at least once in the last month
- Parent:
- Is the parent of a teen driver
- Drives an average of 4 or more trips per week
- Primarily drives one car
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- Admits to texting while driving at least once in the last month
Who cannot join
- Parent and/or teen 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
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Research participants and their parents will be recruited to take part in a randomized control trial. Participants' and their parents' cellphone use will be observed during an initial baseline period. Participants and their parents will then be randomly assigned to one of two conditions: opt-out blocking with parental notification, opt-out blocking with bidirectional notification.
Read the detailed description
In 2012, 3,328 people were killed and an additional 421,000 were injured in crashes involving a distracted driver. Adults aged greater than 40 years old accounted for 44% of these fatalities. Teen driving behavior is heavily influenced by parental driving behaviors with a recent study showing the proportion of teens that text while driving is 14% higher if they have observed their parents doing the same. The proportion of adults who text while driving has recently surpassed teen rates with a 2013 national poll finding 49% of adult car commuters admit to texting while driving, most stating that they did it out of habit. Based on previous findings, it is unlikely that teens will reduce their texting while driving unless their parents do the same.
The objective of this study is to compare measures of acceptance and feasibility across teen-parent dyads randomized to bidirectional teen-parent (teen monitors parent and parent monitors teen) vs. teen only (parent monitors teen) cellphone use while driving.
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 be randomly assigned to one of two conditions (bidirectional teen-parent monitoring or parental monitoring of the teen only). An exit survey and interview will be administered to both the parent and teen separately at the end of the study.
- Conditions
- Teen Drivers, Motor Vehicle Accidents
- Being tested
- CellControl
- 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.
CellControlDevice
Also called DriveID
Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks during baseline measurement period. During the intervention period (5 weeks) cellphone use will be monitored and blocking of incoming calls and texts will be active.
| Study group | Role | What they receive |
|---|---|---|
| Teen-Parent Monitoring Group | Experimental | Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa.
Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. Receives: Device: CellControl |
| Teen Only Monitoring Group | Experimental | Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use.
Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. Receives: Device: CellControl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Cellphone Unlocks Per Hour of Drive Time
Change in number of cellphone unlocks per hour of drive time between baseline and the end of the intervention period
Measured: 8 weeks
Secondary outcomes (1)
Change in the Number of Minutes of Phone Use Per Hour of Driving
Change in the number of minutes of phone use per hour of driving between baseline and the end of the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start7 Dec 2016
- Primary completion13 Sep 2017
- Study completion16 Nov 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT02923271
- Sponsor's protocol ID
- 15-011835
- Status last verified
- Aug 2019
- First submitted
- 3 Oct 2016
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Intrafamily Accountability for Reducing Cellphone Use While Driving in Adults and Their Teen Children
- ClinicalTrials.gov ID
- NCT02923271
- Acronym / sponsor ID
- 15-011835
- Conditions
- Teen Drivers, Motor Vehicle Accidents
- Keywords
- Driving, Teens, Texting, Cellphone, DriveID, Motor vehicle accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 9 Aug 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 and their parents will be recruited to take part in a randomized control trial. Participants' and their parents' cellphone use will be observed during an initial baseline period. Participants and their parents will then be randomly assigned to one of two conditions: opt-out blocking with parental notification, opt-out blocking with bidirectional notification.
Detailed description
In 2012, 3,328 people were killed and an additional 421,000 were injured in crashes involving a distracted driver. Adults aged greater than 40 years old accounted for 44% of these fatalities. Teen driving behavior is heavily influenced by parental driving behaviors with a recent study showing the proportion of teens that text while driving is 14% higher if they have observed their parents doing the same. The proportion of adults who text while driving has recently surpassed teen rates with a 2013 national poll finding 49% of adult car commuters admit to texting while driving, most stating that they did it out of habit. Based on previous findings, it is unlikely that teens will reduce their texting while driving unless their parents do the same.
The objective of this study is to compare measures of acceptance and feasibility across teen-parent dyads randomized to bidirectional teen-parent (teen monitors parent and parent monitors teen) vs. teen only (parent monitors teen) cellphone use while driving.
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 be randomly assigned to one of two conditions (bidirectional teen-parent monitoring or parental monitoring of the teen only). An exit survey and interview will be administered to both the parent and teen separately at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen-Parent Monitoring Group | Experimental | Device: CellControlCellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa. Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. |
| Teen Only Monitoring Group | Experimental | Device: CellControlCellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use. Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Both parent and teen will be enrolled together as a pair
- Teen:
- Parent:
Key exclusion criteria (1 listed)
- Parent and/or teen 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 |
|---|---|---|
| CellControlAlso: DriveIDTechnology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks during baseline measurement period. During the intervention period (5 weeks) cellphone use will be monitored and blocking of incoming calls and texts will be active. | Device | Teen Only Monitoring Group, Teen-Parent Monitoring Group |
Primary outcome
Change in Number of Cellphone Unlocks Per Hour of Drive Time
Time frame: 8 weeks
Change in number of cellphone unlocks per hour of drive time between baseline and the end of the intervention period
1 secondary outcome
Change in the Number of Minutes of Phone Use Per Hour of Driving
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Teen Drivers
Active, not recruiting
Transportation Safety in Adolescence
Automobile Accident
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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 of Teen Drivers and Motor Vehicle Accidents, 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 15 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 20 Aug 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. 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 9 Aug 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 Number of Cellphone Unlocks Per Hour of Drive Time (time frame: 8 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 20 Aug 2019.