Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
Healthy Volunteers
NCT07478458

ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

Led by Istituto Giannina Gaslini · Updated on 2026-03-17

120

Participants Needed

2

Research Sites

111 weeks

Total Duration

On this page

Sponsors

I

Istituto Giannina Gaslini

Lead Sponsor

I

IRCCS Fondazione Stella Maris

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

Who Can Participate

Age: 13Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 13 and 18 years (up to 19 years old)
  • Diagnosis of ADHD (hyperactive, inattentive, or combined subtype) for ADHD group
  • Consent to participate from participant or parent/guardian
  • Age- and sex-matched neurotypical adolescents for control group
  • No diagnosis of ADHD or other neurodevelopmental disorders for control group
  • Informed consent obtained from participant or guardian and assent from minors
Not Eligible

You will not qualify if you...

  • Visual deficits not corrected or correctable with normal lenses
  • Motor deficits or neurological/psychiatric conditions affecting simulator use
  • Diagnoses of psychosis, mood disorders, autism spectrum disorders, intellectual disabilities, borderline intellectual functioning, or anxiety disorders
  • Other conditions affecting driving ability
  • Refusal or withdrawal of consent to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Istituto Giannina Gaslini

Genoa, GE, Italy, 16147

Actively Recruiting

2

IRCCS Fondazione Stella Maris

Pisa, PI, Italy, 56128

Actively Recruiting

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Research Team

L

Lino Nobili, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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