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Clinical Trials in Italy / NCT07478458
Recruiting Not applicable

ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

NCT07478458 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Giannina Gaslini
Phase
Not applicable
Started
2025-11-10
Last updated
2026-03-17

Condition(s) studied

ADHD - Attention Deficit Disorder With Hyperactivity

Investigational drug(s) / intervention(s)

ADRIS-ADHD

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.

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
18 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
IRCCS Istituto Giannina Gaslini Genoa GE Recruiting
IRCCS Fondazione Stella Maris Pisa PI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07478458 on ClinicalTrials.gov ↗ ← All trials in Italy