ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder (NCT07478458) | Clinical Trial Compass
RecruitingNot Applicable
ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
Italy120 participantsStarted 2025-11-10
Plain-language summary
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.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Attention assessment in adolescents with / without ADHD using ADRIS driving simulator