- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06611241
Hazard Anticipation Program for Parents of Teen Drivers (HazAPP)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52240
- University of Iowa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents must be between the ages of 14 and 17 years. Additionally, they must be in the learner period of licensure.
- Parents must be the primary instructor of their teen's supervised driving.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hazard Anticipation Program for Parents of Teen Drivers
Parents and teens randomly assigned to this arm of the trial will engage in a web-based training that provides parents with guidance on how to train their teen to identify potential hazards on the roadway.
Parents are also given an opportunity to practice these new skills with teens when watching videos unfold together.
The program will take 4 hours to complete and can be done over a two-week period at the parent's convenience.
|
Parents and teens who receive the intervention will complete a web-based training that provides parents with guidance on how to teach their teen to identify potential hazards on the roadway.
The program begins by providing background on teens' difficulty learning this skill and the motivational interviewing techniques that are being used in the course.
Parents then engage with a series of hazard videos.
For each hazard, parents watch the hazard unfold, provide an example of what they might say to their teen in that, and are provided with examples of how to coach their teen through the hazard before it becomes a critical event.
Parents and teens then jointly watch 12 videos depicting hazards unfolding on the roadway.
Teens are asked to identify the hazard without parental input by pressing a spacebar.
Teens must also indicate what they believe was the key event that caused the hazard.
Then parents and teens are given an opportunity to replay the video and discuss the hazard together.
Other Names:
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No Intervention: Control
The parents and teens in this arm of the study will not receive an intervention of any kind.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental instruction of teen's driving in vehicle
Time Frame: Measures of parental instruction of teen's driving in the simulator will take place approximately between weeks 2 and 4 weeks of study enrollment.
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Investigators will code whether the parent verbally identifies the hazard, whether instruction from parents is functional or higher order in nature, and if instruction precedes or follows the hazard event.
Functional instruction refers to instruction that applies only to the current context (e.g., "Slow down.").
High-order instruction can be applied more generally to driving (e.g., "When there are brake lights ahead, be ready to brake too.") or why the hazard is dangerous by causally connecting dangerous features and their potential outcomes
|
Measures of parental instruction of teen's driving in the simulator will take place approximately between weeks 2 and 4 weeks of study enrollment.
|
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Parental instruction of teen's driving in simulator
Time Frame: Measures of parental instruction of teen's driving in the simulator will take place approximately 4 weeks after enrollment.
|
For the simulator drive, investigators will code whether the parent verbally identifies the hazard, whether instruction from parents is functional or higher order in nature, and if instruction precedes or follows the hazard event.
Functional instruction refers to instruction that applies only to the current context (e.g., "Slow down.").
High-order instruction can be applied more generally to driving (e.g., "When there are brake lights ahead, be ready to brake too.") or why the hazard is dangerous by causally connecting dangerous features and their potential outcomes
|
Measures of parental instruction of teen's driving in the simulator will take place approximately 4 weeks after enrollment.
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Teens driving performance in simulator - lane position
Time Frame: Measures of teen's driving performance in the simulator will take place approximately 4 weeks after enrollment.
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For the simulator driver investigators will also measure if parental instruction result in improved driving performance among teens.
The investigators will specifically measure differences in lane position among the two groups in response to roadway hazards and parental instruction.
|
Measures of teen's driving performance in the simulator will take place approximately 4 weeks after enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teens driving performance - accelerator release
Time Frame: Measures of teen's accelerator release in the simulator will take place approximately 4 weeks after enrollment.
|
For the simulator driver investigators will also measure if parental instruction result in improved driving performance among teens.
Investigators will specifically measure differences in accelerator release among the two groups in response to roadway hazards and parental instruction.
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Measures of teen's accelerator release in the simulator will take place approximately 4 weeks after enrollment.
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Teens driving performance in simulator - brake force
Time Frame: Measures of teen's driving performance in the simulator will take place approximately 4 weeks after enrollment.
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For the simulator driver investigators will also measure if parental instruction result in improved driving performance among teens.
Investigators will specifically measure differences in lane position among the two groups in response to roadway hazards and parental instruction.
|
Measures of teen's driving performance in the simulator will take place approximately 4 weeks after enrollment.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202010535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data that will program performance metrics (reaction time, accuracy). Data gathered during testing includes reduced metrics of simulator driving performance (speed, lane position, brake force, and acceleration), video capture of parent-teen interactions in naturalistic and simulated roadway environments, parent-teen interaction data reduced via reliable conversation coding, and questionnaire data reported by both parents and teens (e.g., family communication pattern, parenting style, teen temperament, assessment of the driving environment during driving sessions).
Shared data will be de-identified and original data will be maintained at the primary investigator's institution. Video data will be deidentified to the extent possible.
The investigators will archive all data, metadata, study protocols, and demonstration videos on Databrary (https://nyu.databrary.org/). Databrary is an NSF- and NIH-supported data sharing and archiving site, specializing in studies with children.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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