- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Héloïse BAILLET, Dr
- 전화번호: +33232293047
- 이메일: h.baillet@hlrs-lamusse.net
연구 장소
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Saint-Sébastien-de-Morsent, 프랑스, 27180
- Hôpital La Musse
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of driving errors in various scenarios using a driving simulator.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual exploration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-A02129-40
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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