RECRUITINGINTERVENTIONAL

ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

About This Trial

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 May Be Eligible (Plain English)

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 - willing to sign a consent form obtained from the participant if of legal age or from the legal guardian and assent from the minor Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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