What is ADRIS 2.1 studying for adolescents with ADHD?

ADRIS 2.1 is being studied to understand how ADHD affects driving behavior in adolescents aged 13 to 18. Researchers are comparing driving performance, attention, and physiological responses between adolescents with and without ADHD. This study helps inform new tools for assessing and potentially improving driving skills in this group.

Who may be eligible for this ADHD clinical trial?

Adolescents aged 13 to 18 years with a diagnosis of ADHD or typically developing adolescents without neurodevelopmental disorders may be eligible. Participants must also have no severe visual or motor impairments and no other psychiatric diagnoses like mood or anxiety disorders. Please review eligibility criteria for more details.

Is there any cost to participate in this ADHD clinical trial?

Study-related care, including use of the ADRIS simulator and all trial visits, is provided at no cost. However, participants may need to cover their own travel and related expenses, which are not guaranteed to be reimbursed.

Actively Recruiting

Phase Not Applicable

Age: 13Years - 18Years

All Genders

Healthy Volunteers

ID07478458

Study of ADRIS 2.1 Driving Simulator in Adolescents Aged 13 to 18 With and Without ADHD Evaluating Attention, Behavior, and Driving Performance Using Simulator Training

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

120

Participants Needed

Research Sites

N/A

Total Duration

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

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)