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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

  1. Improvements in risky driving and crash risk

Secondary outcomes (1)

  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.

  1. First posted12 Jun 2009 (estimated)
  2. Study start5 Jun 2009
  3. Primary completion29 Mar 2012
  4. Study completion29 Mar 2012

Resources

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)
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 12221026

  • Foss 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 12535909

  • Hartos 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

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.

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