ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Attention assessment in adolescents with / without ADHD using ADRIS driving simulator
研究概览
简要总结
This study aims to evaluate a new driving simulator, called ADRIS 2.1, developed for adolescents aged 13-18 years with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that can affect attention, self-control, and decision-making. These challenges may impact daily activities, including driving.
The ADRIS simulator allows participants to "drive" in a virtual environment while their performance is monitored. The system measures driving errors (such as not stopping at red lights), head and body movements, and heart rate, helping researchers understand how ADHD may affect driving-related behavior.
Participants in the study will include both adolescents with ADHD and typically developing adolescents. All participants will complete standardized cognitive and behavioral assessments and take part in at least one driving simulation session. Adolescents with ADHD will return for follow-up visits and a subgroup will participate in a 6-week training program using the simulator.
The main goal of the study is to measure differences in driving performance and attention between adolescents with and without ADHD. The study will also explore whether the simulator can detect improvements over time and in response to clinical treatment or simulator-based training.
The results may help inform future clinical evaluations and support tools for adolescents with ADHD, with the potential to improve safety and quality of life.
详细描述
INTRODUCTION
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental condition characterized by persistent symptoms of inattention, hyperactivity, and impulsivity. These impairments can significantly impact an adolescent's daily functioning, academic achievement, and social development. Among the various life skills affected by ADHD, driving represents a particularly complex and high-risk activity, requiring the integration of cognitive, attentional, and executive functions. Adolescents with ADHD are disproportionately involved in traffic violations and accidents compared to their neurotypical peers, largely due to reduced inhibitory control, poor hazard perception, and increased distractibility.
Traditional clinical assessments often fail to capture how cognitive and behavioral deficits associated with ADHD manifest in ecologically valid tasks such as driving. Existing tools are limited in their ability to provide objective, task-based evaluations of attention and self-regulation under realistic conditions. Moreover, there is a scarcity of tailored assessment instruments for the adolescent ADHD population, especially those that can be integrated into clinical pathways for diagnosis, monitoring, and intervention.
RATIONALE OF THE STUDY
This study addresses the need for innovative tools to assess and monitor cognitive-behavioral functioning in adolescents with ADHD. We introduce ADRIS 2.1, a customizable driving simulation platform specifically designed for this population. ADRIS integrates real-time measurement of driving behavior, physiological response (heart rate), and body movements, offering a safe and standardized environment for testing attention, impulse control, and decision-making in dynamic scenarios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for ADHD subjects:
- •Age range 13-18 years (up to the age of nineteen)
- •Diagnosis of ADHD (hyperactive, inattentive and combined subtype)
- •Consent to participate in the study by the participant or, in the case of a minor, by their parent(s)/guardian(s).
- •Inclusion Criteria for Control Group subjects:
- •Age- and sex-matched neurotypical adolescents
- •No diagnosis of ADHD or other neurodevelopmental disorders
- •Informed consent obtained from the participant if of legal age or from the legal guardian and assent from the minor
排除标准
- •Visual deficits not corrected/correctable with the normal use of lenses.
- •Motor deficits clinically detected and/or previously diagnosed and that could compromise the use of the simulator (e.g. neurological diseases, psychiatric diseases, etc.).
- •Categorical diagnoses according to DSM-5 criteria such as Psychosis, Mood Disorders, Autism Spectrum Disorders, Intellectual Disabilities, Borderline Intellectual Functioning, Anxiety Disorders.
- •Patients with other conditions that could affect driving ability.
- •Denial / withddrawal of consent to the protocol
研究组 & 干预措施
ADHD Adolescents evaluation pre and post clinical standard treatment
Treatment-naive ADHD patients aged 13-18 years will undergo a clinical assessment and a driving simulation session (ADRIS) to evaluate changes in driving behavior, attention, and cognitive performance using both simulator data and standardized neuropsychological testing. Evaluations will be performed at baseline and repeated after 3 months of standard clinical treatment.
Healthy controls
Healthy controls aged 13-18 years. Age- and sex-matched adolescents without neurocognitive or psychiatric disorders. Participants will undergo a single clinical assessment and driving simulation session (ADRIS) to establish normative data for comparison with the ADHD group. No treatment or intervention will be administered. This arm will not be evaluated as experimental group or comparator in the pre-/post- ADRIS driving training assessments.
ADHD Adolescent without ADRIS Training
Participants (13-18 yo) with ADHD who do not receive ADRIS training. They will be enrolled in the third phase of the study and will undergo the simulator test sessions and the neuropsychological testing (excluding cognitive evaluation) without taking part in ADRIS training sessions. This subgroup will serve as the comparator group to the ADRIS-trained group
ADHD adolescents with ADRIS Training
ADHD participants (13-18 yo) undergoing an intensive training program with the ADRIS simulator (12 sessions, twice a week for 6 weeks) with pre- and post-training evaluation (driving simulator tasks and neuropsychological testing excluding cognitive evaluation)
干预措施: ADRIS-ADHD (Device)
结局指标
主要结局
Attention assessment in adolescents with / without ADHD using ADRIS driving simulator
时间窗: [Baseline - T0] Day 0
Difference in total number of driving infractions in adolescents with / without ADHD, assessed using ADRIS driving simulator. Number of infractions (N) are calculated as the sum of: * ignored stop signs (N) * ignored red lights (N) * collisions (N) * wrong way driving (N) * speed limits ignored (N) * ignored safety distance (N). These measures are directly provided by the simulator). Unit of measure: count (N)
次要结局
- Heart rate differences in driving subjects (adolescents with / without ADHD)([Baseline - T0] Day 0)
- Self reported behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients([Baseline - T0] Day 0, [T1] Month 3, [T2] 6 weeks after [T0] or [T1])
- Heart rate variability differences in driving subjects (adolescents with / without ADHD)([Baseline - T0] Day 0)
- Trunk movements differences in driving subjects (adolescents with/without ADHD)([Baseline - T0] Day 0)
- Head direction differences in driving subjects (adolescents with/without ADHD)([Baseline - T0] Day 0)
- Cognitive assessment with Wechsler Scale in ADHD patients([Baseline - T0] Day 0)
- Behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients, as reported by their parents or primary caregivers.([Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1])
- Attention, behavior, and emotional regulation assessment in ADHD patients([Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1])
- Visual-Motor Integration assessment in ADHD patients([Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1])
- Sustained and selective attention assessment in ADHD patients([Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1])
- Inhibitory control and cognitive interference assessment in ADHD patients([Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1])