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

15 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

22

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Altro: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Altro: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of driving errors in various scenarios using a driving simulator.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual exploration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hopital La Musse

Collaboratori

French Road Safety Delegation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-A02129-40

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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