Behavioral InterventionPhase 3NCT00340470
Michigan Driver Education Study
A Phase 3 study testing Driver Education in people with Behavioral Intervention, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's… Read more about this study
- Who is it for?
- Ages 15 to 16 years
- Conditions the study is for
- Behavioral Intervention
- What is being tested?
- Driver Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2003to 6 Feb 2007
- Phase
- Phase 3
- 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 15 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate.
Who cannot join
- Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-0624
About this study
Official title: Michigan Young Drivers Intervention Study
Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's permit.
The purpose of this study is to evaluate the efficacy of the Checkpoints Program.
Approximately 400 teens in Michigan will participate in one of two study groups. One group will take standard driver education classes; the other group will take driver education classes that incorporate the Checkpoints Program. Teens and their parents will complete a written survey after completing the classes and a telephone survey after teens obtain a driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months after obtaining a driver's permit. Researchers will use this information to study how parents manage teen driving practices, teen driving experiences (amount and conditions of), and high-risk teen driving behaviors.
Read the detailed description
Teens are at high risk for traffic violations and motor vehicle crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. Crash risk is greatest during the first two years of driving, and especially elevated during the first months of driving. Increasing parent involvement is becoming an important target of young driver education; however, little attention has been devoted to parental management of teen driving after teen licensure. Increased parental management of teen driving could reduce the risk of serious injury during the first months of driving and establish clear expectations for their teens' safe driving thereafter. In two randomized trials, the Checkpoints Program has been demonstrated to increase parental restrictions on teen driving through at least four months post-licensure. In this proposed research, we will evaluate the efficacy of the Checkpoints Program as applied to driver education. The purpose of this study is to assess the extent to which exposure to the Checkpoints Program during driver education classes in Michigan results in increased restrictions on young drivers during the first year of provisional licensure. The design is a randomized trial in which 24-30 commercial driver education classes will be randomly assigned to be either standard driver education or driver education that integrates the Checkpoints Program, Approximately 400 teens enrolled in driver education and one of their parents will be recruited and will complete written surveys at baseline and telephone surveys one month after teens obtained provisional licenses. Teens will complete additional telephone surveys one, three, six, and 12 months after provisional licensure. Study outcomes include parent management practices of teen driving, teen driving experience including the amount and conditions of driving during the first 12 months of licensure, and teen risky driving behaviors.
- Conditions
- Behavioral Intervention
- Being tested
- Driver Education
- Keywords
- Injury, Motor Vehicle, Parenting, Randomized Trial, Behavioral Intervention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driver EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of the parent-teen driving agreement.
Secondary outcomes (1)
Prent-imposed driving restrictions during the first 12 months of driving.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start24 Jul 2003
- Study completion6 Feb 2007
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 Behavioral InterventionStudies 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 3
- Primary purpose
- Treatment
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340470
- Sponsor's protocol ID
- 999903262
- Other IDs
- 03-CH-N262
- Status last verified
- 6 Feb 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Doherty ST, Andrey JC, MacGregor C. The situational risks of young drivers: the influence of passengers, time of day and day of week on accident rates. Accid Anal Prev. 1998 Jan;30(1):45-52. doi: 10.1016/s0001-4575(97)00060-2.
PubMed 9542543
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Young Drivers Intervention Study
- ClinicalTrials.gov ID
- NCT00340470
- Acronym / sponsor ID
- 999903262
- Conditions
- Behavioral Intervention
- Keywords
- Injury, Motor Vehicle, Parenting, Randomized Trial, Behavioral Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 24 Jul 2003
- Study completion
- 6 Feb 2007
- First posted
- 21 Jun 2006 (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.
Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's permit.
The purpose of this study is to evaluate the efficacy of the Checkpoints Program.
Approximately 400 teens in Michigan will participate in one of two study groups. One group will take standard driver education classes; the other group will take driver education classes that incorporate the Checkpoints Program. Teens and their parents will complete a written survey after completing the classes and a telephone survey after teens obtain a driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months after obtaining a driver's permit. Researchers will use this information to study how parents manage teen driving practices, teen driving experiences (amount and conditions of), and high-risk teen driving behaviors.
Detailed description
Teens are at high risk for traffic violations and motor vehicle crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. Crash risk is greatest during the first two years of driving, and especially elevated during the first months of driving. Increasing parent involvement is becoming an important target of young driver education; however, little attention has been devoted to parental management of teen driving after teen licensure. Increased parental management of teen driving could reduce the risk of serious injury during the first months of driving and establish clear expectations for their teens' safe driving thereafter. In two randomized trials, the Checkpoints Program has been demonstrated to increase parental restrictions on teen driving through at least four months post-licensure. In this proposed research, we will evaluate the efficacy of the Checkpoints Program as applied to driver education. The purpose of this study is to assess the extent to which exposure to the Checkpoints Program during driver education classes in Michigan results in increased restrictions on young drivers during the first year of provisional licensure. The design is a randomized trial in which 24-30 commercial driver education classes will be randomly assigned to be either standard driver education or driver education that integrates the Checkpoints Program, Approximately 400 teens enrolled in driver education and one of their parents will be recruited and will complete written surveys at baseline and telephone surveys one month after teens obtained provisional licenses. Teens will complete additional telephone surveys one, three, six, and 12 months after provisional licensure. Study outcomes include parent management practices of teen driving, teen driving experience including the amount and conditions of driving during the first 12 months of licensure, and teen risky driving behaviors.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate.
Key exclusion criteria (1 listed)
- Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for 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 |
|---|---|---|
| Driver Education | Behavioural | – |
Primary outcome
Adoption of the parent-teen driving agreement.
1 secondary outcome
Prent-imposed driving restrictions during the first 12 months of driving.
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 2 Jul 2017.
- Background: PubMed 9542543Doherty ST, Andrey JC, MacGregor C. The situational risks of young drivers: the influence of passengers, time of day and day of week on accident rates. Accid Anal Prev. 1998 Jan;30(1):45-52. doi: 10.1016/s0001-4575(97)00060-2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Driver Education in people with Behavioral Intervention, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adoption of the parent-teen driving agreement.. 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 NCT00340470, 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 2 Jul 2017.