- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Héloïse BAILLET, Dr
- Telefonní číslo: +33232293047
- E-mail: h.baillet@hlrs-lamusse.net
Studijní místa
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Saint-Sébastien-de-Morsent, Francie, 27180
- Hôpital La Musse
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Assessment of driving errors in various scenarios using a driving simulator.
Časové okno: At enrollment
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Each adolescent's driving performance will be measured, following Michon's model, through two distinct levels of assessment:
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At enrollment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual exploration
Časové okno: At enrollment
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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-road
Časové okno: At enrollment
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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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Assessment of executive functions and attention
Časové okno: 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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Driving performance on the simulator
Časové okno: 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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Anxiety - State-Trait Anxiety Inventory Y-form
Časové okno: At enrollment
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-A02129-40
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