InjuryPhase 1/2NCT00920049
Preventing Motor Vehicle Crashes Among Young Drivers: Evaluation of the Checkpoints Program Presented by the American Automobile Association
A Phase 1/2 study testing Persuasion in people with Injury, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: Automobile crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Persuasion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2009to 29 Mar 2012
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The adolescent is between the ages of 15 years 6 months to 17 years 0 month at time of recruitment;
- The adolescent lives with the parent or legal guardian at least 50% of the time;
- The parent has routine access to the internet and is able to complete on line surveys in English;
- A parent or legal guardian agrees to participate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
Official title: Preventing Motor Vehicle Crashes Among Young Drivers: Evaluation of the AAA Checkpoints Program
Background:
- Automobile crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. The only approaches to this problem that have demonstrated effectiveness are Graduated Driver Licensing (GDL) and parental management.
- The Checkpoints Program consists of persuasive messages and materials designed to increase adoption of the Checkpoints Parent-Teen Driving Agreement and to improve parents' ability to set limits on higher-risk driving privileges for novice drivers. Researchers are interested in determining whether expanding the Checkpoints Program to an online version (instead of through the mail) can help improve parent limit-setting in connection with the program.
Read more
Objectives:
- To determine the feasibility and effectiveness of conducting an online version of the Checkpoints Program through American Automobile Association (AAA) clubs.
- To test rates of parental intervention and limit-setting after participation in the Checkpoints Program.
Eligibility:
- Parents whose teenage children are enrolled in AAA-affiliated driving schools.
Design:
- Parents with children at the permit stage of driver's education will be recruited through AAA clubs and will be asked to visit a designated Web site to sign up for the program.
- Parents will provide consent and complete the baseline survey, and will be assigned to random groups to test different versions of the Checkpoints Program (the intervention or a control group Web site).
- The intervention program will contain videos, regular e-mails, and newsletters on setting parental limits and information on specific teen driving risks. The control program will provide information on various topics related to the licensing procedure and safe driving, but no specific information on teen driving risks.
- A follow-up assessment will be conducted 1 month after the teenager receives his or her license.
Read the detailed description
Crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. Graduate Driver Licensing (GDL) and parental management are the only approaches to this problem with demonstrated effectiveness. The Checkpoints Program consists of persuasive messages and materials designed to increase adoption of the Checkpoints Parent-Teen Driving Agreement and increase parent limit setting on higher-risk driving privileges among novice teenage drivers. The current study builds on the results of several previous trials of the Checkpoints Program that have shown significant treatment group effects on parent limit setting, teen risky driving, and violations. The purpose of this study is to determine the efficacy of conducting an online adaptation of the Checkpoints Program through the American Automobile Association (AAA) clubs. The study will be conducted with parents whose teenage children are enrolled in AAA-affiliated driving schools. 800 families will be recruited through AAA Clubs, assigned to intervention or comparison groups, provided online access to Checkpoints or comparison materials, and assessed at baseline and after teen licensure.
- Conditions
- Injury
- Being tested
- Persuasion
- Keywords
- Driving, Injury, Prevention, Intervention, Parents
- 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.
PersuasionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in risky driving and crash risk
Secondary outcomes (1)
Adoption of parent-teen driving agreement and adherence to graduated driver licensing policy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study start5 Jun 2009
- Primary completion29 Mar 2012
- Study completion29 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Germaine M Louis, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920049
- Sponsor's protocol ID
- 999909165
- Other IDs
- 09-CH-N165
- Status last verified
- 29 Mar 2012
- First submitted
- 10 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Arnett JJ. Developmental sources of crash risk in young drivers. Inj Prev. 2002 Sep;8 Suppl 2(Suppl 2):ii17-21; discussion ii21-3. doi: 10.1136/ip.8.suppl_2.ii17.
PubMed 12221026Foss R, Goodwin A. Enhancing the effectiveness of graduated driver licensing legislation. J Safety Res. 2003 Jan;34(1):79-84. doi: 10.1016/s0022-4375(02)00083-x.
PubMed 12535909Hartos JL, Nissen WJ, Simons-Morton BG. Acceptability of the Checkpoints Parent-Teen Driving Agreement: pilot test. Am J Prev Med. 2001 Aug;21(2):138-41. doi: 10.1016/s0749-3797(01)00330-0.
PubMed 11457634
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
- Preventing Motor Vehicle Crashes Among Young Drivers: Evaluation of the AAA Checkpoints Program
- ClinicalTrials.gov ID
- NCT00920049
- Acronym / sponsor ID
- 999909165
- Conditions
- Injury
- Keywords
- Driving, Injury, Prevention, Intervention, Parents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 5 Jun 2009
- Primary completion
- 29 Mar 2012 (actual)
- Study completion
- 29 Mar 2012 (actual)
- First posted
- 12 Jun 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.
Background:
- Automobile crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. The only approaches to this problem that have demonstrated effectiveness are Graduated Driver Licensing (GDL) and parental management.
- The Checkpoints Program consists of persuasive messages and materials designed to increase adoption of the Checkpoints Parent-Teen Driving Agreement and to improve parents' ability to set limits on higher-risk driving privileges for novice drivers. Researchers are interested in determining whether expanding the Checkpoints Program to an online version (instead of through the mail) can help improve parent limit-setting in connection with the program.
Objectives:
- To determine the feasibility and effectiveness of conducting an online version of the Checkpoints Program through American Automobile Association (AAA) clubs.
- To test rates of parental intervention and limit-setting after participation in the Checkpoints Program.
Eligibility:
- Parents whose teenage children are enrolled in AAA-affiliated driving schools.
Design:
- Parents with children at the permit stage of driver's education will be recruited through AAA clubs and will be asked to visit a designated Web site to sign up for the program.
- Parents will provide consent and complete the baseline survey, and will be assigned to random groups to test different versions of the Checkpoints Program (the intervention or a control group Web site).
- The intervention program will contain videos, regular e-mails, and newsletters on setting parental limits and information on specific teen driving risks. The control program will provide information on various topics related to the licensing procedure and safe driving, but no specific information on teen driving risks.
- A follow-up assessment will be conducted 1 month after the teenager receives his or her license.
Detailed description
Crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. Graduate Driver Licensing (GDL) and parental management are the only approaches to this problem with demonstrated effectiveness. The Checkpoints Program consists of persuasive messages and materials designed to increase adoption of the Checkpoints Parent-Teen Driving Agreement and increase parent limit setting on higher-risk driving privileges among novice teenage drivers. The current study builds on the results of several previous trials of the Checkpoints Program that have shown significant treatment group effects on parent limit setting, teen risky driving, and violations. The purpose of this study is to determine the efficacy of conducting an online adaptation of the Checkpoints Program through the American Automobile Association (AAA) clubs. The study will be conducted with parents whose teenage children are enrolled in AAA-affiliated driving schools. 800 families will be recruited through AAA Clubs, assigned to intervention or comparison groups, provided online access to Checkpoints or comparison materials, and assessed at baseline and after teen licensure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Persuasion | Behavioural | – |
Primary outcome
Improvements in risky driving and crash risk
1 secondary outcome
Adoption of parent-teen driving agreement and adherence to graduated driver licensing policy
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 12221026Arnett JJ. Developmental sources of crash risk in young drivers. Inj Prev. 2002 Sep;8 Suppl 2(Suppl 2):ii17-21; discussion ii21-3. doi: 10.1136/ip.8.suppl_2.ii17.
- Background: PubMed 12535909Foss R, Goodwin A. Enhancing the effectiveness of graduated driver licensing legislation. J Safety Res. 2003 Jan;34(1):79-84. doi: 10.1016/s0022-4375(02)00083-x.
- Background: PubMed 11457634Hartos JL, Nissen WJ, Simons-Morton BG. Acceptability of the Checkpoints Parent-Teen Driving Agreement: pilot test. Am J Prev Med. 2001 Aug;21(2):138-41. doi: 10.1016/s0749-3797(01)00330-0.
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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.
Germaine M Louis, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Persuasion in people with Injury, 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 4 inclusion and 0 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Improvements in risky driving and crash risk. 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 NCT00920049, which also lists 3 linked publications.
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.