AdolescentNCT02319317
Web-based Intervention to Prevent Risky Driving
A study testing Risky driving prevention in people with Adolescent and Accidents, Traffic, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to 31 Jul 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
- Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
- Pennsylvania driver's license for 90 days or less at time of assent
- Personal email address and computer and internet access
- Willingness to travel to CHOP twice to complete simulated assessment
- Ability to read and write English
Who cannot join
- Self-reported of claustrophobia, migraine headaches, or motion sickness
- Self-reported current pregnancy
- . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months
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: Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.
Read the detailed description
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving teen drivers licensed in the previous 90 days. The intervention will focus on promoting teen driver attention to the roadway.
The investigators will use a randomized controlled trial (RCT) experimental design for this feasibility study, randomizing to the intervention or control group. The investigators will complete a baseline assessment and follow up with participants at 1-month, 3-months and 6-months post-intervention delivery.
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 simulated driving performance, self-reported driving behaviors, crash and citation data.
- Conditions
- Adolescent, Accidents, Traffic, Attention, Motor Vehicles
- Being tested
- Risky driving prevention, Control group general health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risky driving preventionBehavioural
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.
Control group general health promotionBehavioural
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: Control group general health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Participants
Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
Measured: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Secondary outcomes (5)
Proportion of Participants Randomized
Proportion of participants screened, enrolled and randomized
Measured: Baseline (Study Visit 1)
Adherence
Adherence among the intervention and control group to the intervention.
Measured: Baseline (Study Visit 1) through completion of the intervention.
Simulated Driving Performance
Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).
Measured: Baseline (Study Visit 1) through Study Visit 3
Self-report Driving Behaviors
Difference between the intervention and control group on self-report measures of driving behaviors.
Measured: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Driving Citations and Crashes
Difference between the intervention and control group on driving citations and crashes.
Measured: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completion31 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Catherine C McDonald, PhD, RN, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319317
- Sponsor's protocol ID
- R00NR013548
- Other IDs
- R00NR013548, 14-011336, 821064
- Status last verified
- Oct 2017
- First submitted
- 8 Dec 2014
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McDonald CC, Sommers MS, Fargo JD, Seacrist T, Power T. Simulated Driving Performance, Self-Reported Driving Behaviors, and Mental Health Symptoms in Adolescent Novice Drivers. Nurs Res. 2018 May/Jun;67(3):202-211. doi: 10.1097/NNR.0000000000000270.
PubMed 29701615
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
- ClinicalTrials.gov ID
- NCT02319317
- Acronym / sponsor ID
- R00NR013548
- Conditions
- Adolescent, Accidents, Traffic, Attention, Motor Vehicles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.
Detailed description
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving teen drivers licensed in the previous 90 days. The intervention will focus on promoting teen driver attention to the roadway.
The investigators will use a randomized controlled trial (RCT) experimental design for this feasibility study, randomizing to the intervention or control group. The investigators will complete a baseline assessment and follow up with participants at 1-month, 3-months and 6-months post-intervention delivery.
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 simulated driving performance, self-reported driving behaviors, crash and citation data.
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: Control group general health promotionWeb-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 (5 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).
- Pennsylvania driver's license for 90 days or less at time of assent
- Personal email address and computer and internet access
- Willingness to travel to CHOP twice to complete simulated assessment
- Ability to read and write English
Key exclusion criteria (3 listed)
- Self-reported of claustrophobia, migraine headaches, or motion sickness
- Self-reported current pregnancy
- . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months
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 preventionThe 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 |
| Control group general health promotionThe 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 Study Visit 4 (around 6 months).
Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
5 secondary outcomes
Proportion of Participants Randomized
Time frame: Baseline (Study Visit 1)
Adherence
Time frame: Baseline (Study Visit 1) through completion of the intervention.
Simulated Driving Performance
Time frame: Baseline (Study Visit 1) through Study Visit 3
Self-report Driving Behaviors
Time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Driving Citations and Crashes
Time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29701615McDonald CC, Sommers MS, Fargo JD, Seacrist T, Power T. Simulated Driving Performance, Self-Reported Driving Behaviors, and Mental Health Symptoms in Adolescent Novice Drivers. Nurs Res. 2018 May/Jun;67(3):202-211. doi: 10.1097/NNR.0000000000000270.
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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.
Catherine C McDonald, PhD, RN principal investigator
University of Pennsylvania
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 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 5 inclusion and 3 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 Nov 2017. 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 4 Oct 2017). 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?
Retention of Participants (time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).). 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 NCT02319317, which also lists 1 linked publication.
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 Nov 2017.