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Набор скоро начнётся NCT07630298

A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents

Без фазы С лечением Autism Spectrum Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessment of executive functions and attention, Evaluation on a driving simulator, Evaluation on-road.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorders. Базовые параметры: 15 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Assessment of driving errors in various scenarios using a driving simulator. [Срок оценки: At enrollment]
Вторичные конечные точки (5)
  • Visual exploration [Срок оценки: At enrollment]
  • Driving performance on the simulator [Срок оценки: At enrollment]
  • Driving performance on-road [Срок оценки: At enrollment]
  • Anxiety - State-Trait Anxiety Inventory Y-form [Срок оценки: At enrollment]
  • Assessment of executive functions and attention [Срок оценки: At enrollment]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Hôpital La Musse — Saint-Sébastien-de-Morsent

Идентификаторы

NCT: NCT07630298 · 2025-A02129-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗