AdolescentNCT02695888
Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
A study testing Risky Driving Prevention and Teen Healthy Living in people with Adolescent and Accidents, Traffic, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers. Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent, Accidents, Traffic, Attention
- What is being tested?
- Risky Driving Prevention and Teen Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to 29 Dec 2016
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- PA driver's license for 90 days or less at time of teen assent
- Personal email address and computer and internet access
- Ability to read and write English
- Primarily drives one vehicle with the ability to accommodate the DriveID device
- Parental consent and teen assent
Who cannot join
- Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
- Unable to follow study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4217
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4217
About this study
Official title: A Pilot Study of a Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
Read the detailed description
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers. Approximately 20 teens who have been licensed for less than 90 days will be enrolled and evaluated at baseline, ~1 week and ~4 weeks. Participants will complete an intervention after the ~1 week assessment. This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on cell phone use while driving.
- Conditions
- Adolescent, Accidents, Traffic, Attention, Motor Vehicles
- Being tested
- Risky Driving Prevention, Teen Healthy Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risky Driving PreventionBehavioural
Also called Web-based intervention to prevent risky driving
The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
Teen Healthy LivingBehavioural
The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
| Study group | Role | What they receive |
|---|---|---|
| Risky driving prevention | Experimental | Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers. Receives: Behavioral: Risky Driving Prevention |
| Control group | Experimental | Web-based behavioral intervention for healthy lifestyles. Receives: Behavioral: Teen Healthy Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of participants
Proportion of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
Measured: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Secondary outcomes (2)
In-vehicle cell phone use
Difference between the intervention and control group on frequency of cell phone use while driving as monitored by an in-vehicle device
Measured: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Self-reported driving behaviors
Difference between the intervention and control group on on self-report measures of driving behaviors
Measured: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695888
- Sponsor's protocol ID
- 15-012431
- Other IDs
- 823913
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
- ClinicalTrials.gov ID
- NCT02695888
- Acronym / sponsor ID
- 15-012431
- Conditions
- Adolescent, Accidents, Traffic, Attention, Motor Vehicles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Mar 2016
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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.
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
Detailed description
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers. Approximately 20 teens who have been licensed for less than 90 days will be enrolled and evaluated at baseline, ~1 week and ~4 weeks. Participants will complete an intervention after the ~1 week assessment. This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on cell phone use while driving.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risky driving prevention | Experimental | Behavioral: Risky Driving PreventionWeb-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers. |
| Control group | Experimental | Behavioral: Teen Healthy LivingWeb-based behavioral intervention for healthy lifestyles. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- PA driver's license for 90 days or less at time of teen assent
- Personal email address and computer and internet access
- Ability to read and write English
Key exclusion criteria (2 listed)
- Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
- Unable to follow study procedures
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 |
|---|---|---|
| Risky Driving PreventionAlso: Web-based intervention to prevent risky drivingThe web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway. | Behavioural | Risky driving prevention |
| Teen Healthy LivingThe control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease. | Behavioural | Control group |
Primary outcome
Retention of participants
Time frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Proportion of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
2 secondary outcomes
In-vehicle cell phone use
Time frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Self-reported driving behaviors
Time frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
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 18 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risky Driving Prevention and Teen Healthy Living in people with Adolescent and Accidents, Traffic, run by University of Pennsylvania 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 7 inclusion and 2 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 18 Oct 2018. 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?
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?
Retention of participants (time frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)). 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 18 Oct 2018.