Virtual driving coach could cut crashes for ADHD teens

NCT ID NCT07478458

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a driving simulator called ADRIS 2.1 for teens aged 13-18 with ADHD. The simulator tracks driving errors like running red lights or speeding, and some participants will get 12 training sessions over 6 weeks. Researchers want to see if the simulator can improve attention and reduce mistakes behind the wheel.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ADRIS driving simulator (device-based training program)
What this could lead to
If successful, this could lead to a new training tool that helps teens with ADHD become safer drivers.
What could go wrong
This is an early-stage study with only 120 participants. The simulator may not improve real-world driving or work for all teens with ADHD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Fondazione Stella Maris

    RECRUITING

    Pisa, PI, 56128, Italy

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genoa, GE, 16147, Italy

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