ADRIS 2.1 driving simulator for adolescents with ADHD.
ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
This project will test whether the ADRIS 2.1 driving simulator can measure and train driving-related skills in adolescents aged 13–18 with ADHD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Istituto Giannina Gaslini Academic / other |
| Locations | 2 sites (Genoa, GE and 1 other locations) |
| Trial ID | NCT07478458 on ClinicalTrials.gov |
What this trial studies
Researchers will have adolescents with ADHD and age- and sex-matched neurotypical peers complete standardized cognitive and behavioral assessments and drive in the ADRIS 2.1 virtual simulator while researchers record driving errors, head and body movements, and heart rate. The platform generates objective, task-based metrics of attention, impulsivity, and hazard response in a controlled virtual environment. Adolescents with ADHD will return for follow-up visits and a subset will undergo a six-week simulator-based training program to test for performance changes. The study is conducted at pediatric research centers in Genoa and Pisa, Italy, and compares simulator outcomes between groups and over time.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13–18 with a DSM-5 diagnosis of ADHD (any subtype) and age- and sex-matched neurotypical adolescents for the control group.
Not a fit: Patients with uncorrected visual or motor impairments, or with major psychiatric or neurodevelopmental diagnoses such as psychosis, mood disorders, autism spectrum disorder, or intellectual disability are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, ADRIS could provide objective measures of driving risk and a practical training tool to help reduce driving errors and improve safety for adolescents with ADHD.
How similar studies have performed: Driving simulators have been used in prior ADHD research and have shown promising but limited evidence for detecting deficits and improving some driving-related skills, so the approach is partially supported but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Genoa, GE and 1 other locations
- IRCCS Istituto Giannina Gaslini — Genoa, Ge, Italy (Recruiting)
- IRCCS Fondazione Stella Maris — Pisa, Pi, Italy (Recruiting)
Study contacts
- Principal investigator: Lino Nobili, MD PhD — IRCCS Istituto Giannina Gaslini
- Study coordinator: Lino Nobili, MD PhD
- Email: linonobili@gaslini.org
- Phone: +3901056262381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.