Attention-deficit hyperactivity disorder.
Jonathan Posner, Guilherme V Polanczyk, Edmund Sonuga-Barke
https://pubmed.ncbi.nlm.nih.gov/31982036Actively Recruiting
Phase Not Applicable
Age: 13Years - 18Years
All Genders
Healthy Volunteers
ID07478458
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
N/A
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
Researchers are evaluating ADRIS 2.1, a new driving simulator designed for adolescents aged 13 to 18 years with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that impacts attention, self-control, and decision-making, which can affect everyday activities like driving. This study compares driving performance and attention between adolescents with ADHD and those without, aiming to understand how ADHD influences driving behavior and to explore improvements through clinical treatment or training. The study involves both adolescents with ADHD and typically developing peers. Participants will complete cognitive and behavioral assessments and take part in driving simulation sessions using the ADRIS system, which tracks driving errors, body movements, and heart rate. A subgroup of ADHD participants will undergo a 6-week intensive training program with the simulator, while others will be observed without training. Assessments occur at baseline, after 3 months, and following the training period. Participants will attend multiple visits for neuropsychological testing and simulator sessions. The study collects data on driving violations, physiological responses, and cognitive performance to assess attention and impulsivity. Monitoring includes questionnaires and repeated simulator tests to track changes over time. The study aims to provide objective measures that may support future ADHD assessments and interventions, with total participation lasting up to several months depending on group assignment.
CONDITIONS
Brief Title
ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
Who Can Participate
Age: 13Years - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 13 and 18 years (up to 19 years old)
- Diagnosis of ADHD including hyperactive, inattentive, or combined subtypes
- Consent to participate provided by participant or parent/guardian if minor
- Age- and sex-matched neurotypical adolescents without ADHD or other neurodevelopmental disorders
- Informed consent from participant if of legal age, or from legal guardian, plus assent from minor
You will not qualify if you...
- Uncorrected or uncorrectable visual deficits
- Motor deficits or neurological/psychiatric diseases affecting simulator use
- Diagnoses of psychosis, mood disorders, autism spectrum disorders, intellectual disabilities, borderline intellectual functioning, or anxiety disorders
- Other medical conditions that could affect driving ability
- Withdrawal or denial of consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Evaluation
Duration - 1 day
Participants undergo clinical assessments and initial driving simulation sessions to evaluate attention, driving behavior, and cognitive performance using the ADRIS driving simulator and standardized neuropsychological testing.
1 visit (in-person)
Follow-up Evaluation
Duration - 1 day
ADHD participants repeat the driving simulation session and neuropsychological assessments (excluding cognitive battery) approximately 3 months after baseline to monitor changes following standard clinical treatment.
1 visit (in-person) at 3 months
ADRIS Training Period
Duration - 6 weeks
A subgroup of ADHD participants undergo intensive ADRIS simulator training consisting of 12 sessions over 6 weeks to improve attention regulation and driving strategies. Training sessions are conducted twice a week.
12 visits (in-person, twice weekly)
Pre- and Post-Training Assessments
Duration - Before and after the 6-week training period
Participants in the ADRIS training subgroup are evaluated with driving simulation tests and neuropsychological assessments before and after the training period. A control subgroup undergoes the same evaluations without training.
2 visits (in-person)
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
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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