ADRIS 2.1 driving simulator for adolescents with ADHD.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will have adolescents with ADHD and age- and sex-matched neurotypical peers complete standardized cognitive and behavioral assessments and drive in the ADRIS 2.1 virtual simulator while researchers record driving errors, head and body movements, and heart rate. The platform generates objective, task-based metrics of attention, impulsivity, and hazard response in a controlled virtual environment. Adolescents with ADHD will return for follow-up visits and a subset will undergo a six-week simulator-based training program to test for performance changes. The study is conducted at pediatric research centers in Genoa and Pisa, Italy, and compares simulator outcomes between groups and over time.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Istituto Giannina Gaslini
  Genoa, Ge, Italy Recruiting
• IRCCS Fondazione Stella Maris
  Pisa, Pi, Italy Recruiting

Study contacts

• Principal investigator: Lino Nobili, MD PhD — IRCCS Istituto Giannina Gaslini
• Study coordinator: Lino Nobili, MD PhD
• Email: linonobili@gaslini.org
• Phone: +3901056262381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.