Motor Vehicle Occupant InjuryNCT01014923
Parent-based Intervention to Increase Safe Teen Driving
A study testing Teen driving intervention in people with Motor Vehicle Occupant Injury and Teenaged Driver, run by University of Iowa at 2 sites in United States.
Trial summary
We hypothesize that this intervention will increase the quality and quantity of parental interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be individually randomized into intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motor Vehicle Occupant Injury, Teenaged Driver
- What is being tested?
- Teen driving intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Dec 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parent and teen dyads of newly-licensed teenaged drivers that speak English
Who cannot join
- siblings of previously enrolled dyads, teens who will not drive independently after licensure
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
We hypothesize that this intervention will increase the quality and quantity of parental interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be individually randomized into intervention and control groups. The intervention group will receive a tailored, in-person intervention with a trained member of the research team, with follow-up intervention phone calls each month for the 3-month intervention. The control group will be a "usual care" group who will receive driving safety materials available to all new drivers and their parents. Parents and teens will be followed to see if intervention parents meet the intervention's driving goals and to see if the parent and teens report improved driving skills and behaviors in the intervention compared with the control group.
Read the detailed description
Drivers in their first six months of licensure have the highest crash rates of all drivers, leading to high rates of injury for themselves, their passengers, and those they hit. Parents play a critical role in the driving experience of their children. Policy approaches, such as Graduated Driver's Licensing Systems, and educational programs that encourage parents to define driving rules and restrictions have shown some success in reducing teen risky driving. However, methods to increase parental involvement in teaching driving skills and encouraging safe driving behaviors have not been widely tested. Such interventions can augment existing GDL systems by increasing parental knowledge and involvement in learning to drive.
The long-range goal of this research is to develop a sustainable and generalizable intervention that will reduce crashes and related injuries among teen drivers by increasing safe driving practices. The investigators propose to conduct a randomized trial of an educational intervention for parents of newly licensed adolescent drivers to increase parental involvement in teaching driving skills and safe driving behavior. Seven schools in small towns in the state of Iowa have agreed to participate. These schools are all within 50 miles of Des Moines, Iowa's largest city, which will lead to driving exposure in rural and town environments.
Parents of newly-licensed teenaged drivers will be the primary subjects enrolled in this study, and parents only will participate in the intervention. Teen drivers will also be enrolled so that they can provide information about their driving attitudes and behaviors; their role will be limited to filling out surveys. The intervention will include a focus on teaching driving skills and behaviors and on effective communication strategies with teens. The intervention content includes specific driving goals that parents meet with their teen drivers that focus on skills and behavior. This project will be conducted in a rural population, so skills for driving on rural roads will be included. The delivery of the intervention will use motivational interviewing, a successful and age-appropriate health behavior communication technique that has shown great success in related health fields.
250 parent/teen dyads will be individually randomized into intervention and control groups. The intervention group will receive a tailored, in-person intervention with a trained member of the research team, with follow-up intervention phone calls each month for the 3-month intervention. The control group will be a "usual care" group who will receive driving safety materials available to all new drivers and their parents. Parents and teens will be followed to see if intervention parents meet the intervention's driving goals and to see if the parent and teens report improved driving skills and behaviors in the intervention compared with the control group.
- Conditions
- Motor Vehicle Occupant Injury, Teenaged Driver
- Being tested
- Teen driving intervention
- Keywords
- motor vehicle, accidents, traffic, prevention and control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen driving interventionBehavioural
Parents of new teen drivers receive guidebook to teach driving skills and safety behaviors; individual instruction on parent-child communication about driving; DVD demonstrating safe driving communication; and, 26-page booklet on driving goals and conversation topics
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents of new teen drivers receive guidebook to teach driving skills and safety behaviors; individual instruction on parent-child communication about driving; DVD demonstrating safe driving communication; and, 26-page booklet on driving goals and conversation topics Receives: Behavioral: Teen driving intervention |
| Control | No intervention | Parents receive a Department of Transportation booklet on teen driving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Safety Communication
Measured: 6 months post-intervention
Risky Driving Inventory
Measured: 6-months post intervention
Secondary outcomes (2)
Driving citations and crashes
Measured: through one year post-intervention
parent risky driving inventory
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor Vehicle Occupant InjuryStudies of the same condition, open and under way.
- 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Blank Children's Hospital
- Investigators
- Corinne Peek-Asa, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014923
- Sponsor's protocol ID
- CE000947
- Other IDs
- CDC NCIPC R49 CE000947
- Status last verified
- Feb 2011
- First submitted
- 16 Nov 2009
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peek-Asa C, Cavanaugh JE, Yang J, Chande V, Young T, Ramirez M. Steering teens safe: a randomized trial of a parent-based intervention to improve safe teen driving. BMC Public Health. 2014 Jul 31;14:777. doi: 10.1186/1471-2458-14-777.
PubMed 25082132
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-based Intervention to Increase Safe Teen Driving
- ClinicalTrials.gov ID
- NCT01014923
- Acronym / sponsor ID
- CE000947
- Conditions
- Motor Vehicle Occupant Injury, Teenaged Driver
- Keywords
- motor vehicle, accidents, traffic, prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Blank Children's Hospital
- Study start
- Jul 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Nov 2009 (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.
We hypothesize that this intervention will increase the quality and quantity of parental interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be individually randomized into intervention and control groups. The intervention group will receive a tailored, in-person intervention with a trained member of the research team, with follow-up intervention phone calls each month for the 3-month intervention. The control group will be a "usual care" group who will receive driving safety materials available to all new drivers and their parents. Parents and teens will be followed to see if intervention parents meet the intervention's driving goals and to see if the parent and teens report improved driving skills and behaviors in the intervention compared with the control group.
Detailed description
Drivers in their first six months of licensure have the highest crash rates of all drivers, leading to high rates of injury for themselves, their passengers, and those they hit. Parents play a critical role in the driving experience of their children. Policy approaches, such as Graduated Driver's Licensing Systems, and educational programs that encourage parents to define driving rules and restrictions have shown some success in reducing teen risky driving. However, methods to increase parental involvement in teaching driving skills and encouraging safe driving behaviors have not been widely tested. Such interventions can augment existing GDL systems by increasing parental knowledge and involvement in learning to drive.
The long-range goal of this research is to develop a sustainable and generalizable intervention that will reduce crashes and related injuries among teen drivers by increasing safe driving practices. The investigators propose to conduct a randomized trial of an educational intervention for parents of newly licensed adolescent drivers to increase parental involvement in teaching driving skills and safe driving behavior. Seven schools in small towns in the state of Iowa have agreed to participate. These schools are all within 50 miles of Des Moines, Iowa's largest city, which will lead to driving exposure in rural and town environments.
Parents of newly-licensed teenaged drivers will be the primary subjects enrolled in this study, and parents only will participate in the intervention. Teen drivers will also be enrolled so that they can provide information about their driving attitudes and behaviors; their role will be limited to filling out surveys. The intervention will include a focus on teaching driving skills and behaviors and on effective communication strategies with teens. The intervention content includes specific driving goals that parents meet with their teen drivers that focus on skills and behavior. This project will be conducted in a rural population, so skills for driving on rural roads will be included. The delivery of the intervention will use motivational interviewing, a successful and age-appropriate health behavior communication technique that has shown great success in related health fields.
250 parent/teen dyads will be individually randomized into intervention and control groups. The intervention group will receive a tailored, in-person intervention with a trained member of the research team, with follow-up intervention phone calls each month for the 3-month intervention. The control group will be a "usual care" group who will receive driving safety materials available to all new drivers and their parents. Parents and teens will be followed to see if intervention parents meet the intervention's driving goals and to see if the parent and teens report improved driving skills and behaviors in the intervention compared with the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Teen driving interventionParents of new teen drivers receive guidebook to teach driving skills and safety behaviors; individual instruction on parent-child communication about driving; DVD demonstrating safe driving communication; and, 26-page booklet on driving goals and conversation topics |
| Control | No intervention | –Parents receive a Department of Transportation booklet on teen driving |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- parent and teen dyads of newly-licensed teenaged drivers that speak English
Key exclusion criteria (1 listed)
- siblings of previously enrolled dyads, teens who will not drive independently after licensure
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 |
|---|---|---|
| Teen driving interventionParents of new teen drivers receive guidebook to teach driving skills and safety behaviors; individual instruction on parent-child communication about driving; DVD demonstrating safe driving communication; and, 26-page booklet on driving goals and conversation topics | Behavioural | Intervention |
Primary outcome
Driving Safety Communication
Time frame: 6 months post-intervention
Risky Driving Inventory
Time frame: 6-months post intervention
2 secondary outcomes
Driving citations and crashes
Time frame: through one year post-intervention
parent risky driving inventory
Time frame: 6 months post-intervention
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 21 Feb 2011.
- Derived from this study: PubMed 25082132Peek-Asa C, Cavanaugh JE, Yang J, Chande V, Young T, Ramirez M. Steering teens safe: a randomized trial of a parent-based intervention to improve safe teen driving. BMC Public Health. 2014 Jul 31;14:777. doi: 10.1186/1471-2458-14-777.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen driving intervention in people with Motor Vehicle Occupant Injury and Teenaged Driver, 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 1 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 21 Feb 2011. 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 Safety Communication (time frame: 6 months post-intervention). The study lists 2 primary outcomes in all. 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 NCT01014923, 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 21 Feb 2011.