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

15 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

22

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Outro: 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.
Outro: 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.
Outro: 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.
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:

  • 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.
Outro: 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.
Outro: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Assessment of driving errors in various scenarios using a driving simulator.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual exploration
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hopital La Musse

Colaboradores

French Road Safety Delegation

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2025-A02129-40

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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