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ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

Key facts

Who runs it
Istituto Giannina Gaslini
Where
Italy2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
120 people, planned
Started
10 Nov 2025
Expected to end
Jan 2028
Type of study
Interventional, 4 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • ADRIS-ADHD
Record updated
17 March 2026

Who can take part

Age
13 years to 18 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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)
  • 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

Who cannot take part

  • 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
  • Visual deficits not corrected/correctable with the normal use of lenses
  • Denial / withddrawal of consent to the protocol

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 13 and 18 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 4 groups in the trial

  • ADHD Adolescents evaluation pre and post clinical standard treatmentNo study treatment, for comparison

    Treatment-naive ADHD patients aged 13-18 years will undergo a clinical assessment and a driving simulation session (ADRIS) to evaluate changes in driving behavior, attention, and cognitive performance using both simulator data and standardized neuropsychological testing. Evaluations will be performed at baseline and repeated after 3 months of standard clinical treatment.

  • Healthy controlsNo study treatment, for comparison

    Healthy controls aged 13-18 years. Age- and sex-matched adolescents without neurocognitive or psychiatric disorders. Participants will undergo a single clinical assessment and driving simulation session (ADRIS) to establish normative data for comparison with the ADHD group. No treatment or intervention will be administered. This arm will not be evaluated as experimental group or comparator in the pre-/post- ADRIS driving training assessments.

  • ADHD Adolescent without ADRIS TrainingNo study treatment, for comparison

    Participants (13-18 yo) with ADHD who do not receive ADRIS training. They will be enrolled in the third phase of the study and will undergo the simulator test sessions and the neuropsychological testing (excluding cognitive evaluation) without taking part in ADRIS training sessions. This subgroup will serve as the comparator group to the ADRIS-trained group

  • ADHD adolescents with ADRIS TrainingTreatment being tested

    ADHD participants (13-18 yo) undergoing an intensive training program with the ADRIS simulator (12 sessions, twice a week for 6 weeks) with pre- and post-training evaluation (driving simulator tasks and neuropsychological testing excluding cognitive evaluation)

    Treatment: ADRIS-ADHD

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07478458, who can take part
Record updated
17 March 2026