Motor Vehicle DrivingNCT01624597
A Randomized Controlled Trial to Improve Teen Driving
A study testing Parent communication in people with Motor Vehicle Driving, run by University of Iowa at 2 sites in United States.
Trial summary
This randomized controlled trial will evaluate an intervention that provides parents with objective feedback about their teen's driving as well as strategies to improve communication with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent or guardian. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Vehicle Driving
- What is being tested?
- Parent communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to May 2018
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teen will receive Intermediate Driver's license in three months
- Teen has regular access to a car
- Can provide proof of insurance
- One legal guardian will also consent to participation
Who cannot join
- Either parent or teen is not an English speaker
- A sibling has already participated in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Blank Children's Hospital
Des Moines, Iowa, 50309
University of Iowa
Iowa City, Iowa, 52242
About this study
This randomized controlled trial will evaluate an intervention that provides parents with objective feedback about their teen's driving as well as strategies to improve communication with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have reduced driving errors and increased safety behaviors than dyads with no feedback; and, parent-teen dyads who receive instruction on communication techniques will have improved quality and quantity of communication about driving than dyads not learning these techniques.
Read the detailed description
With a long-range goal of reducing crashes and related injuries among teen drivers, this project will assess the influence of a parent-focused intervention on teens' driving and safety behaviors. This randomized controlled trial will evaluate an intervention that integrates an in-vehicle video feedback system with parent-based communication techniques to improve teen driving. This will be the first rigorous evaluation of this technology, as well as the first to integrate a parent component. The in-vehicle video system records a video clip whenever an abrupt change in speed or steering direction is detected. These event-triggered video clips will be coded to identify safety-relevant events like driving errors and safety behaviors. A randomized group of parents will receive a weekly "driving report card" that summarizes driving errors, safety behaviors, and crashes or near-crashes recorded by the in-vehicle system. A second group of randomized parents will receive the report card plus training in communication strategies specifically designed to improve parent-teen communication about safe driving (based on Motivational Interviewing). Driving errors and safety behaviors will be compared to a control group that receives no feedback from the in-vehicle video system.
The specific aims of this proposed project are:
Specific Aim 1: Identify if giving parents feedback about their teen's driving performance and skills to better communicate with their teen driver increases the quality and quantity of parental involvement in teen driving.
Hypothesis: The intervention groups will report more frequent and higher-quality communication about safe driving than the control group.
Specific Aim 2: Identify if giving parents feedback about their teen's driving performance and skills to better communicate with their teen driver decreases the frequency of driving errors, unsafe driving behaviors, crashes, and near crashes.
Hypothesis: The intervention groups will have significantly reduced risky driving events (driving errors, crashes, and near crashes) and significantly increased safety behaviors (such as safety belt use and driving without distractions) than the control group.
- Conditions
- Motor Vehicle Driving
- Being tested
- In-vehicle video feedback, Parent communication
- Keywords
- Road traffic safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vehicle video feedbackBehavioural
An in-vehicle video system will record driving errors and safety behaviors. A light on the system will blink to let the participant know that a driving error has been recorded. Parents will receive a weekly report card.
Parent communicationBehavioural
Parents will receive instruction in teaching and effective communication about driving skills and driving safety. The intervention includes driving goals for teen drivers and parent communication strategies.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will have a passive in-vehicle video device installed in their car to measure driving errors and safety behaviors. |
| In-vehicle video feedback | Experimental | Participants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors. Receives: Behavioral: In-vehicle video feedback; Behavioral: Parent communication |
| In-vehicle video feedback, parent communication | Experimental | Participants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors. Parents will participate in an intervention that provides input on teaching and communicating about driving skills and safety behaviors. Receives: Behavioral: Parent communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving errors by newly licensed teen drivers
An in-vehicle video system will be used to measure driving errors made by newly licensed teen drivers
Measured: 6 months after licensure
Secondary outcomes (2)
Safety behaviors of newly licensed teen drivers
An in-vehicle video system will be used to measure safety behaviors practiced by newly licensed teen drivers.
Measured: 6 months post-licensure
Parent communication
Parents and teens will report on communication quality and quantity related to safe driving.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionMay 2015
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Vehicle DrivingStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Corinne Peek-Asa, University of Iowa
- Investigators
- Corinne Peek-Asa, PhD, Principal investigator, University of IowaDaniel McGehee, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624597
- Sponsor's protocol ID
- 065095
- Other IDs
- R01HD065095
- Status last verified
- Aug 2018
- First submitted
- 18 Jun 2012
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve Teen Driving
- ClinicalTrials.gov ID
- NCT01624597
- Acronym / sponsor ID
- 065095
- Conditions
- Motor Vehicle Driving
- Keywords
- Road traffic safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 20 Jun 2012 (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 randomized controlled trial will evaluate an intervention that provides parents with objective feedback about their teen's driving as well as strategies to improve communication with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have reduced driving errors and increased safety behaviors than dyads with no feedback; and, parent-teen dyads who receive instruction on communication techniques will have improved quality and quantity of communication about driving than dyads not learning these techniques.
Detailed description
With a long-range goal of reducing crashes and related injuries among teen drivers, this project will assess the influence of a parent-focused intervention on teens' driving and safety behaviors. This randomized controlled trial will evaluate an intervention that integrates an in-vehicle video feedback system with parent-based communication techniques to improve teen driving. This will be the first rigorous evaluation of this technology, as well as the first to integrate a parent component. The in-vehicle video system records a video clip whenever an abrupt change in speed or steering direction is detected. These event-triggered video clips will be coded to identify safety-relevant events like driving errors and safety behaviors. A randomized group of parents will receive a weekly "driving report card" that summarizes driving errors, safety behaviors, and crashes or near-crashes recorded by the in-vehicle system. A second group of randomized parents will receive the report card plus training in communication strategies specifically designed to improve parent-teen communication about safe driving (based on Motivational Interviewing). Driving errors and safety behaviors will be compared to a control group that receives no feedback from the in-vehicle video system.
The specific aims of this proposed project are:
Specific Aim 1: Identify if giving parents feedback about their teen's driving performance and skills to better communicate with their teen driver increases the quality and quantity of parental involvement in teen driving.
Hypothesis: The intervention groups will report more frequent and higher-quality communication about safe driving than the control group.
Specific Aim 2: Identify if giving parents feedback about their teen's driving performance and skills to better communicate with their teen driver decreases the frequency of driving errors, unsafe driving behaviors, crashes, and near crashes.
Hypothesis: The intervention groups will have significantly reduced risky driving events (driving errors, crashes, and near crashes) and significantly increased safety behaviors (such as safety belt use and driving without distractions) than the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will have a passive in-vehicle video device installed in their car to measure driving errors and safety behaviors. |
| In-vehicle video feedback | Experimental | Behavioral: In-vehicle video feedback, Behavioral: Parent communicationParticipants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors. |
| In-vehicle video feedback, parent communication | Experimental | Behavioral: Parent communicationParticipants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors. Parents will participate in an intervention that provides input on teaching and communicating about driving skills and safety behaviors. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Teen will receive Intermediate Driver's license in three months
- Teen has regular access to a car
- Can provide proof of insurance
- One legal guardian will also consent to participation
Key exclusion criteria (2 listed)
- Either parent or teen is not an English speaker
- A sibling has already participated in the study
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 |
|---|---|---|
| In-vehicle video feedbackAn in-vehicle video system will record driving errors and safety behaviors. A light on the system will blink to let the participant know that a driving error has been recorded. Parents will receive a weekly report card. | Behavioural | In-vehicle video feedback |
| Parent communicationParents will receive instruction in teaching and effective communication about driving skills and driving safety. The intervention includes driving goals for teen drivers and parent communication strategies. | Behavioural | In-vehicle video feedback, In-vehicle video feedback, parent communication |
Primary outcome
Driving errors by newly licensed teen drivers
Time frame: 6 months after licensure
An in-vehicle video system will be used to measure driving errors made by newly licensed teen drivers
2 secondary outcomes
Safety behaviors of newly licensed teen drivers
Time frame: 6 months post-licensure
Parent communication
Time frame: 6 months
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 31 Aug 2018.
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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.
Corinne Peek-Asa, PhD principal investigator
University of Iowa
Daniel McGehee, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent communication in people with Motor Vehicle Driving, run by University of Iowa 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 4 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 31 Aug 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?
Driving errors by newly licensed teen drivers (time frame: 6 months after licensure). 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 31 Aug 2018.