- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630298
A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents (Perf-TSA)
The primary objective of this study is to compare the number of driving errors made by novice adolescents (0-5 hours of driving instruction) with ASD to those made by neurotypical adolescents during a standardized driving simulator assessment. The secondary objectives of the study are to:
- Compare the visual strategies used by adolescents with ASD to those of neurotypical adolescents during a driving assessment on a simulator.
- Compare the types of errors and driving performance (i.e., speed, reaction time, following distance, and braking distance) of adolescents with ASD to those of neurotypical adolescents during the driving simulator assessment.
- Compare the driving performance of these two groups during a real-world road assessment using the TRIP scale.
- Examine the consistency between driving performance measured in the simulator and that observed in real-world conditions for both groups.
- Compare the anxiety levels of these two groups during driving tests on the simulator and on the road.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Héloïse BAILLET, Dr
- Phone Number: +33232293047
- Email: h.baillet@hlrs-lamusse.net
Study Locations
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Saint-Sébastien-de-Morsent, France, 27180
- Hôpital La Musse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
ASD Group
- Adolescents aged 15 to 17,
- With a confirmed diagnosis of ASD by a physician,
- Without an intellectual disability, with a Fluid Reasoning Index (IRF) greater than 80,
- Who have passed the written driver's license exam,
- With no or very limited driving experience (<5 hours),
- Enrolled in the social security system.
Neurotypical group:
- Adolescents aged 15 to 17,
- Without a diagnosis of neurodevelopmental disorders or learning disabilities,
- With a standard educational background,
- Who have passed the written driver's license exam,
- With no or very limited driving experience (<5 hours),
- Enrolled in the social security system.
Exclusion Criteria:
- Adolescents with ADHD (attention-deficit/hyperactivity disorder) and/or ODD (oppositional defiant disorder) and/or IDD (intellectual disability) and/or SLI (specific language impairment) with associated comprehension difficulties,
- Adolescents who already have a driver's license,
- Adolescents currently taking driving lessons and/or with more than 5 hours of driving experience,
- Adolescents who have suffered a head injury during childhood,
- Other serious medical conditions that may interfere with participation in the sessions,
- Participation in another research protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Neurotypical group
Once enrolled, each participant will undergo an assessment of executive functions and attention (conducted by a neuropsychologist, lasting 1 hour and 30 minutes) using the following tests:
Each adolescent will then undergo two driving assessments: one on a driving simulator and one on the road in a dual-control vehicle with a driving instructor. |
The 1-hour simulator assessment will be preceded by a 1.5-hour orientation session.
The simulator used is the Rehab Evolution, manufactured by Develter Innovation.
The on-road evaluation will be conducted using a dual-control vehicle, with a certified driving instructor and an occupational therapist.
The evaluation will last one hour.
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Experimental: ASD group
Once enrolled, each participant will undergo an assessment of executive functions and attention (conducted by a neuropsychologist, lasting 1 hour and 30 minutes) using the following tests:
Each adolescent will then undergo two driving assessments: one on a driving simulator and one on the road in a dual-control vehicle with a driving instructor. |
The 1-hour simulator assessment will be preceded by a 1.5-hour orientation session.
The simulator used is the Rehab Evolution, manufactured by Develter Innovation.
The on-road evaluation will be conducted using a dual-control vehicle, with a certified driving instructor and an occupational therapist.
The evaluation will last one hour.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of driving errors in various scenarios using a driving simulator.
Time Frame: At enrollment
|
Each adolescent's driving performance will be measured, following Michon's model, through two distinct levels of assessment:
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At enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual exploration
Time Frame: At enrollment
|
Visual exploration will be assessed during simulator driving using an infrared eye-tracking device, the Tobii Pro Spark.
This device, paired and synchronized with Develter Innovation's Rehab Evolution driving simulator, will collect eye-tracking data (e.g., number of fixations, fixation duration) from each subject during each scenario at a frequency of 60 Hz.
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At enrollment
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Driving performance on the simulator
Time Frame: At enrollment
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Driving performance on the simulator will be evaluated, on the one hand, using data on speed, reaction time, following distance, and braking distance collected during each test. Additionally, the total driving error score will be broken down into 7 sub-scores, allowing for the evaluation and comparison of driving error types and the levels involved in relation to Michon's model:
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At enrollment
|
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Driving performance on-road
Time Frame: At enrollment
|
During the on-road evaluation, the TRIP scale (Test Ride for Investigating Practical fitness to drive) will be used and completed immediately after the test by an occupational therapist.
This test allows for the standardization and quantification of driving performance using a list of behavioral items: lane position, following distance, speed, visual scanning, traffic signals, passing, anticipation, communication, special situations, vehicle controls, and overall impressions.
Each item is quantified using a score on a scale of 1 to 4 (1: insufficient, 2: questionable, 3: sufficient, 4: good).
The reliability of this test has already been demonstrated in several studies involving various populations, such as older adults, stroke survivors, and individuals with Huntington's disease.
This grid also allows for the calculation of scores corresponding to the different hierarchical levels of Michon's model.
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At enrollment
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Anxiety
Time Frame: At enrollment
|
Participants' anxiety levels during on-road and simulator driving tests will be assessed using the STAI-Y (State-Trait Anxiety Inventory Y-form, Appendix 3).
It will be administered and completed before and after each assessment, both on-road and in the simulator.
The general STAI-Y is a questionnaire designed to assess momentary anxiety and trait anxiety.
For this study, only the state scale of the STAI-Y will be used.
The state anxiety scale comprises 20 items and assesses the feelings of apprehension, tension, nervousness, and worry that the subject experiences at the time of the assessment.
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At enrollment
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Assessment of executive functions and attention
Time Frame: At enrollment
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Assessment of executive functions and attention using the Attention Assessment Test (TAP) with the following subtests: "phasic alerting," "divided attention," "go/no go," "working memory," and "visual scanning", the Trail Making Test (TMT) assessing mental flexibility, the Stroop selective attention test assessing the ability to inhibit automatic processes, and the Wisconsin Card Sorting Test (WSCT-modified), which assesses abstract reasoning and the ability to change cognitive strategies in response to changes in the environment.
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At enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A02129-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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