Automobile AccidentNCT03639753
Transportation Safety in Adolescence
A study testing Parent-Teen Intervention and Usual Practice in people with Automobile Accident, run by University of Pennsylvania at 1 site in United States.
Trial summary
The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes. Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Automobile Accident
- What is being tested?
- Parent-Teen Intervention and Usual Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,216 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teens between 16 and 17 years and 4 months (17.33 years) of age
- Pennsylvania state learner's permits
- Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
- Self-report of less than 10 hours of behind-the-wheel driving experience.
- Teen and parent/caregiver fluent in written and spoken English
- Access to at least one practice vehicle
- Email address and internet access to complete study procedures
Who cannot join
- Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
- Teens with pervasive developmental delays
- Have a sibling enrolled in this study
- Enrolled in other teen driving studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Promoting Transportation Safety in Adolescence
The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.
- Conditions
- Automobile Accident
- Being tested
- Parent-Teen Intervention, Usual Practice
- Keywords
- teen driver safety, injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Teen InterventionBehavioural
Parent health coaching and resources + teen on-road driver experience + safe driving eLearning Modules
Usual PracticeOther
Standard care for teens who get licensed in the state of PA
| Study group | Role | What they receive |
|---|---|---|
| Parent-Teen Intervention | Experimental | Parent health coaching session and supportive materials, teen on road driver assessment with feedback. Receives: Behavioral: Parent-Teen Intervention |
| Usual Practice | Other | Not described Receives: Other: Usual Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Police-reported motor vehicle crashes
Time to first motor vehicle crash
Measured: Licensure to 12 months after licensure
Secondary outcomes (1)
Self-reported motor vehicle crashes
Measured: First 6 months of licensure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start18 Aug 2021
- Primary completion18 Mar 2026
- Study completion31 Aug 2026 (estimated)
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 Automobile AccidentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, University of Alabama at Birmingham, Children's Hospital of Philadelphia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Catherine McDonald, University of Pennsylvania
- Investigators
- Leann Long, PhD, Principal investigator, Wake Forest University Health SciencesCatherine McDonald, PhD, RN, FAAN, Principal investigator, University of PennsylvaniaJessica Mirman, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639753
- Sponsor's protocol ID
- IRB-834765
- Other IDs
- R01HD095248
- Status last verified
- Oct 2025
- First submitted
- 17 Aug 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hafetz J, McDonald CC, Long DL, Ford CA, Mdluli T, Weiss A, Felkins J, Wilson N, MacDonald B. Promoting transportation safety in adolescence: the drivingly randomized controlled trial. BMC Public Health. 2023 Oct 17;23(1):2020. doi: 10.1186/s12889-023-16801-6.
PubMed 37848929
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Transportation Safety in Adolescence
- ClinicalTrials.gov ID
- NCT03639753
- Acronym / sponsor ID
- IRB-834765
- Conditions
- Automobile Accident
- Keywords
- teen driver safety, injury prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,216 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Edinburgh, University of Alabama at Birmingham, Children's Hospital of Philadelphia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Wake Forest University Health Sciences
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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.
The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-Teen Intervention | Experimental | Behavioral: Parent-Teen InterventionParent health coaching session and supportive materials, teen on road driver assessment with feedback. |
| Usual Practice | Other | Other: Usual Practice |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Teens between 16 and 17 years and 4 months (17.33 years) of age
- Pennsylvania state learner's permits
- Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
- Self-report of less than 10 hours of behind-the-wheel driving experience.
- Teen and parent/caregiver fluent in written and spoken English
Key exclusion criteria (4 listed)
- Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
- Teens with pervasive developmental delays
- Have a sibling enrolled in this study
- Enrolled in other teen driving studies
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 |
|---|---|---|
| Parent-Teen InterventionParent health coaching and resources + teen on-road driver experience + safe driving eLearning Modules | Behavioural | Parent-Teen Intervention |
| Usual PracticeStandard care for teens who get licensed in the state of PA | Other | Usual Practice |
Primary outcome
Police-reported motor vehicle crashes
Time frame: Licensure to 12 months after licensure
Time to first motor vehicle crash
1 secondary outcome
Self-reported motor vehicle crashes
Time frame: First 6 months of licensure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 37848929Hafetz J, McDonald CC, Long DL, Ford CA, Mdluli T, Weiss A, Felkins J, Wilson N, MacDonald B. Promoting transportation safety in adolescence: the drivingly randomized controlled trial. BMC Public Health. 2023 Oct 17;23(1):2020. doi: 10.1186/s12889-023-16801-6.
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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.
Leann Long, PhD principal investigator
Wake Forest University Health Sciences
Catherine McDonald, PhD, RN, FAAN principal investigator
University of Pennsylvania
Jessica Mirman, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Teen Intervention and Usual Practice in people with Automobile Accident, run by University of Pennsylvania 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Police-reported motor vehicle crashes (time frame: Licensure to 12 months after licensure). 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 NCT03639753, 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 7 Aug 2026.