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RECRUITING
NCT07478458
NA

ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

Sponsor: Istituto Giannina Gaslini

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

13 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-10

Completion Date

2028-01

Last Updated

2026-03-17

Healthy Volunteers

Yes

Interventions

DEVICE

ADRIS-ADHD

30 ADHD participants will be divided into two subgroups: 15 will undergo an intensive training program with the ADRIS simulator (12 sessions, twice a week for 6 weeks), and they will be evaluated pre- and post-training through driving simulator test sessions and neuropsychological testing excluding cognitive evaluation. A comparator arm of 15 patients will partecipate only in evaluation sessions with no training.

Locations (2)

IRCCS Istituto Giannina Gaslini

Genoa, GE, Italy

IRCCS Fondazione Stella Maris

Pisa, PI, Italy