Autism Spectrum DisordersPerf-TSANCT07630298
A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents
A study testing Assessment of executive functions and attention, Evaluation on a driving simulator and Evaluation on-road in people with Autism Spectrum Disorders, run by Hopital La Musse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Assessment of executive functions and attention, Evaluation on a driving simulator and Evaluation on-road
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2026to 31 Aug 2027
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital La Musse
Saint-Sébastien-de-Morsent, 27180
About this study
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Assessment of executive functions and attention, Evaluation on a driving simulator, Evaluation on-road
- Keywords
- Drive, learning, Driving simulator, ASD
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of executive functions and attentionOther
- Attention Assessment Test (TAP),
- Trail Making Test (TMT), which assesses mental flexibility,
- Stroop Selective Attention Test, assessing the ability to inhibit automatic processes,
- Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment.
Evaluation on a driving simulatorOther
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.
Evaluation on-roadOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurotypical group | Active comparator | 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:
* Attention Assessment Test (TAP),
* Trail Making Test (TMT), which assesses mental flexibility,
* Stroop Selective Attention Test, assessing the ability to inhibit automatic processes,
* Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment.
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. Receives: Other: Assessment of executive functions and attention; Other: Evaluation on a driving simulator; Other: Evaluation on-road |
| ASD group | Experimental | 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:
* Attention Assessment Test (TAP) (25),
* Trail Making Test (TMT), which assesses mental flexibility (26),
* Stroop Selective Attention Test, assessing the ability to inhibit automatic processes (27),
* Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment (28).
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. Receives: Other: Assessment of executive functions and attention; Other: Evaluation on a driving simulator; Other: Evaluation on-road |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of driving errors in various scenarios using a driving simulator.
Each adolescent's driving performance will be measured, following Michon's model, through two distinct levels of assessment:
- Assessment 1 focuses more on the operational level of Michon's model: the participant must control their vehicle while stationary and on the road under simple conditions, i.e., with no other road users and no incidents. During 5 tests, control of the controls, maintaining a straight line and staying in the lane when turning, and maintaining speed at low speeds (50 km/h) and moderate speeds (80 km/h) will be evaluated.
- Assessment 2, which places greater emphasis on tactical skills: The participant will be confronted with more complex situations requiring adaptation of driving to road conditions and other road users. The aim is to gradually introduce additional cognitive demands: visual attention, visual scanning, interaction with other road users, and the management of critical situations in urban and rural environments through six tests.
Measured: At enrollment
Secondary outcomes (5)
Visual exploration
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.
Measured: At enrollment
Driving performance on the simulator
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:
- Control of vehicle controls,
- Lane keeping and speed regulation,
- Vehicle control during turns and speed regulation,
- Visual scanning and divided attention while driving, level 1,
- Visual scanning and divided attention while driving, level 2,
- Executive functions level 1: interactions with traffic,
- Executive functions level 2: management of critical situations. This scale was developed specifically for the study. Scores on the scale range from 0 to 100; the lower the score, the better the teenager's driving performance on the simulator.
Measured: At enrollment
Driving performance on-road
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.
Measured: At enrollment
Anxiety - State-Trait Anxiety Inventory Y-form
Participants' anxiety levels during on-road and simulator driving tests will be assessed using the STAI-Y (State-Trait Anxiety Inventory Y-form). 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.
The STAI-Y scale ranges from 20 to 80. The higher the score, the greater the level of anxiety.
Measured: At enrollment
Assessment of executive functions and attention
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start5 Oct 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Interventional, Single-center, with a control group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Collaborators
- French Road Safety Delegation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630298
- Sponsor's protocol ID
- 2025-A02129-40
- Acronym
- Perf-TSA
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents
- ClinicalTrials.gov ID
- NCT07630298
- Acronym / sponsor ID
- Perf-TSA / 2025-A02129-40
- Conditions
- Autism Spectrum Disorders
- Keywords
- Drive, learning, Driving simulator, ASD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Collaborators
- French Road Safety Delegation
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jun 2026 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Interventional, Single-center, with a control group
| Arm | Type | Receives |
|---|---|---|
| Neurotypical group | Active comparator | Other: Assessment of executive functions and attention, Other: Evaluation on a driving simulator, Other: Evaluation on-roadOnce 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: * Attention Assessment Test (TAP), * Trail Making Test (TMT), which assesses mental flexibility, * Stroop Selective Attention Test, assessing the ability to inhibit automatic processes, * Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment. 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. |
| ASD group | Experimental | Other: Assessment of executive functions and attention, Other: Evaluation on a driving simulator, Other: Evaluation on-roadOnce 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: * Attention Assessment Test (TAP) (25), * Trail Making Test (TMT), which assesses mental flexibility (26), * Stroop Selective Attention Test, assessing the ability to inhibit automatic processes (27), * Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment (28). 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. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Assessment of executive functions and attention* Attention Assessment Test (TAP), * Trail Making Test (TMT), which assesses mental flexibility, * Stroop Selective Attention Test, assessing the ability to inhibit automatic processes, * Wisconsin Card Sorting Test (WSCT-modified), assessing abstract reasoning and the ability to change cognitive strategies in response to changes in the environment. | Other | ASD group, Neurotypical group |
| Evaluation on a driving simulatorThe 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. | Other | ASD group, Neurotypical group |
| Evaluation on-roadThe 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. | Other | ASD group, Neurotypical group |
Primary outcome
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: * Assessment 1 focuses more on the operational level of Michon's model: the participant must control their vehicle while stationary and on the road under simple conditions, i.e., with no other road users and no incidents. During 5 tests, control of the controls, maintaining a straight line and staying in the lane when turning, and maintaining speed at low speeds (50 km/h) and moderate speeds (80 km/h) will be evaluated. * Assessment 2, which places greater emphasis on tactical skills: The participant will be confronted with more complex situations requiring adaptation of driving to road conditions and other road users. The aim is to gradually introduce additional cognitive demands: visual attention, visual scanning, interaction with other road users, and the management of critical situations in urban and rural environments through six tests.
5 secondary outcomes
Visual exploration
Time frame: At enrollment
Driving performance on the simulator
Time frame: At enrollment
Driving performance on-road
Time frame: At enrollment
Anxiety - State-Trait Anxiety Inventory Y-form
Time frame: At enrollment
Assessment of executive functions and attention
Time frame: At enrollment
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of executive functions and attention, Evaluation on a driving simulator and Evaluation on-road in people with Autism Spectrum Disorders, run by Hopital La Musse at 1 site in France.
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 14 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 France. 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?
Contact Héloïse BAILLET, Dr (+33232293047, h.baillet@hlrs-lamusse.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of driving errors in various scenarios using a driving simulator. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.