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A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents (Perf-TSA)

15 czerwca 2026 zaktualizowane przez: Hopital La Musse

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

22

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
      • Saint-Sébastien-de-Morsent, Francja, 27180
        • Hôpital La Musse

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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:

  • 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.
Inny: 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.
Inny: Evaluation on a driving simulator
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.
Inny: Evaluation on-road
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.
Eksperymentalny: 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:

  • 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.
Inny: 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.
Inny: Evaluation on a driving simulator
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.
Inny: Evaluation on-road
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Assessment of driving errors in various scenarios using a driving simulator.
Ramy czasowe: 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.
At enrollment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Visual exploration
Ramy czasowe: 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.
At enrollment
Driving performance on-road
Ramy czasowe: 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.
At enrollment
Assessment of executive functions and attention
Ramy czasowe: At enrollment
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.
At enrollment
Driving performance on the simulator
Ramy czasowe: At enrollment

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.
At enrollment
Anxiety - State-Trait Anxiety Inventory Y-form
Ramy czasowe: 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). 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.
At enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hopital La Musse

Współpracownicy

French Road Safety Delegation

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2027

Ukończenie studiów (Szacowany)

31 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-A02129-40

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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