ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

NCT07478458 | Recruiting

• 2 other identifiers: ADRIS-ADHDFit for Medical Robotics
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Driving simulator

Outcome Measures

Primary Outcomes (1)

• Attention assessment in adolescents with / without ADHD using ADRIS driving simulator

  Difference in total number of driving infractions in adolescents with / without ADHD, assessed using ADRIS driving simulator. Number of infractions (N) are calculated as the sum of: * ignored stop signs (N) * ignored red lights (N) * collisions (N) * wrong way driving (N) * speed limits ignored (N) * ignored safety distance (N). These measures are directly provided by the simulator). Unit of measure: count (N)

  [Baseline - T0] Day 0

Secondary Outcomes (11)

• Heart rate differences in driving subjects (adolescents with / without ADHD)

  [Baseline - T0] Day 0

• Heart rate variability differences in driving subjects (adolescents with / without ADHD)

  [Baseline - T0] Day 0

• Trunk movements differences in driving subjects (adolescents with/without ADHD)

  [Baseline - T0] Day 0

• Head direction differences in driving subjects (adolescents with/without ADHD)

  [Baseline - T0] Day 0

• Cognitive assessment with Wechsler Scale in ADHD patients

  [Baseline - T0] Day 0

Study Arms (4)

ADHD Adolescents evaluation pre and post clinical standard treatment

NO INTERVENTION

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 controls

NO INTERVENTION

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 Training

NO INTERVENTION

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 Training

EXPERIMENTAL

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)

Device: ADRIS-ADHD

Interventions

ADRIS-ADHD DEVICE

30 ADHD participants will be divided into two subgroups: 15 will undergo an intensive training program with the ADRIS simulator (12 sessions, twice a week for 6 weeks), and they will be evaluated pre- and post-training through driving simulator test sessions and neuropsychological testing excluding cognitive evaluation. A comparator arm of 15 patients will partecipate only in evaluation sessions with no training.

ADHD adolescents with ADRIS Training

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead
• IRCCS Fondazione Stella Maris: collaborator
• University of Genova: collaborator

Study Sites (2)

IRCCS Istituto Giannina Gaslini

Genoa, GE, 16147, Italy

RECRUITING

IRCCS Fondazione Stella Maris

Pisa, PI, 56128, Italy

RECRUITING

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lino Nobili, MD PhD

  IRCCS Istituto Giannina Gaslini

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lino Nobili, MD PhD

CONTACT

+3901056262381; linonobili@gaslini.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the first phase of the study, 60 subjects with ADHD will be assessed using neuropsychological tests, while 60 control subjects without ADHD will complete a brief questionnaire to evaluate attentional and executive functioning. Both groups will also be assessed through the performance of tasks using the ADRIS driving simulator. In the second phase, subjects with ADHD will undergo a follow-up assessment using neuropsychological tests (excluding cognitive evaluation) and tasks on the ADRIS driving simulator, in order to investigate any cognitive-behavioral changes following the therapy prescribed as per standard of care. In the third phase, 30 subjects with ADHD will be divided into two groups of 15 subjects each. One group will complete neuropsychological tests (excluding cognitive evaluation) and driving simulator tasks before and after a training cycle of ADRIS, while the other group will undergo the same assessments without the training.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: March 17, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

IT (2)