NCT07630298

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Aug 2027

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 1, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

DrivelearningDriving simulatorASD

Outcome Measures

Primary Outcomes (1)

  • Assessment of driving errors in various scenarios using a driving simulator.

    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

Secondary Outcomes (5)

  • Visual exploration

    At enrollment

  • Driving performance on the simulator

    At enrollment

  • Driving performance on-road

    At enrollment

  • Anxiety - State-Trait Anxiety Inventory Y-form

    At enrollment

  • Assessment of executive functions and attention

    At enrollment

Study Arms (2)

Neurotypical group

ACTIVE COMPARATOR

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.

Other: Assessment of executive functions and attentionOther: Evaluation on a driving simulatorOther: Evaluation on-road

ASD group

EXPERIMENTAL

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.

Other: Assessment of executive functions and attentionOther: Evaluation on a driving simulatorOther: Evaluation on-road

Interventions

* 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.

ASD groupNeurotypical group

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.

ASD groupNeurotypical group

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.

ASD groupNeurotypical group

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, 27180, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Héloïse BAILLET, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, Interventional, Single-center, with a control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations