ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder (ADRIS-ADHD)

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD - Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: ADRIS-ADHD

Detailed Description

INTRODUCTION

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental condition characterized by persistent symptoms of inattention, hyperactivity, and impulsivity. These impairments can significantly impact an adolescent's daily functioning, academic achievement, and social development. Among the various life skills affected by ADHD, driving represents a particularly complex and high-risk activity, requiring the integration of cognitive, attentional, and executive functions. Adolescents with ADHD are disproportionately involved in traffic violations and accidents compared to their neurotypical peers, largely due to reduced inhibitory control, poor hazard perception, and increased distractibility.

Traditional clinical assessments often fail to capture how cognitive and behavioral deficits associated with ADHD manifest in ecologically valid tasks such as driving. Existing tools are limited in their ability to provide objective, task-based evaluations of attention and self-regulation under realistic conditions. Moreover, there is a scarcity of tailored assessment instruments for the adolescent ADHD population, especially those that can be integrated into clinical pathways for diagnosis, monitoring, and intervention.

RATIONALE OF THE STUDY

This study addresses the need for innovative tools to assess and monitor cognitive-behavioral functioning in adolescents with ADHD. We introduce ADRIS 2.1, a customizable driving simulation platform specifically designed for this population. ADRIS integrates real-time measurement of driving behavior, physiological response (heart rate), and body movements, offering a safe and standardized environment for testing attention, impulse control, and decision-making in dynamic scenarios.

Unlike conventional evaluations, ADRIS allows for adaptive testing: the simulation parameters (e.g., scenario duration, obstacle type, voice prompts) can be modified to match the cognitive load and attentional profile of the user. This flexibility enables clinicians to replicate real-world challenges while collecting objective, quantifiable data related to attentional lapses, impulsive actions, and physiological stress responses.

The study aims to validate ADRIS as a clinical support tool by comparing the driving performance of adolescents with and without ADHD, assessing the correlation between simulator outcomes and standardized neuropsychological tests, and analyzing changes in driving behavior following usual clinical interventions (pharmacological and non-pharmacological). In addition, the study explores whether repeated training with ADRIS may contribute to improvements in attention regulation and driving strategies.

DEVICE DESCRIPTION

ADRIS 2.1 is a driving simulator composed of the following components:

• Steering wheel and pedals connected to a PlayStation console
• 32" monitor displaying high-resolution driving environments
• Integrated camera system for tracking head and torso movements
• Heart rate monitor positioned on the left pectoral area

The system is supported by software developed on the Unreal Engine platform, designed to:

• Generate realistic urban and suburban driving scenarios
• Provide interactive navigation with auditory guidance
• Present neutral, congruent, and incongruent visual stimuli to test attentional control
• Acquire and analyze metrics such as lane crossing, reaction time, speed variability, and physiological responses

STUDY OBJECTIVES

Primary Objective:

Compare the number of traffic violations (e.g., ignored stop signs, red lights, speed limits, collisions) between adolescents with ADHD and neurotypical controls as an index of impulsivity and attentional regulation.

Secondary Objectives:

• Analyze body movement and heart rate data to assess physiological and behavioral differences during driving tasks
• Correlate simulator performance with standardized neuropsychological test results
• Monitor intra-individual changes over time (baseline vs. follow-up) to assess the impact of clinical treatments
• Evaluate the effect of repeated ADRIS-based training on driving behavior and attentional control in a randomized subgroup

PARTICIPANTS

A total of 120 participants (60 ADHD, 60 controls) aged 13 to 18 years will be enrolled across two centers: IRCCS Istituto Giannina Gaslini (Genoa) and IRCCS Fondazione Stella Maris (Pisa). Recruitment will include both clinic-referred individuals and participants engaged via ADHD family associations and educational institutions.

STUDY PROCEDURES

T0 (All participants):

ADHD group: full neuropsychological battery, standardized questionnaires (e.g., WISC/WAIS, NEPSY-II, CBCL, CONNERS 3), first ADRIS session (6 driving scenarios)

Control group: short screening questionnaire, ADRIS simulator session (same protocol)

T1 (ADHD only):

At 3 months: repeat ADRIS session and neuropsychological assessments (excluding cognitive battery)

T2 Sub-study (ADHD only):

30 ADHD participants will be randomized into two age- and sex-matched groups:

Training group: 12 simulator training sessions over 6 weeks

Control group: no training

Both subgroups will undergo pre- and post-training ADRIS testing and neuropsychological evaluation (excluding cognitive battery)

STIMULI AND TASK DESIGN

During simulator sessions, participants will encounter:

• Neutral stimuli: non-threatening static obstacles (e.g., trash bins)
• Congruent stimuli: dynamic, context-appropriate obstacles (e.g., pedestrian crossing)
• Incongruent stimuli: misleading cues followed by sudden hazards (e.g., decoy pedestrian followed by car)

These scenarios test attentional capture, inhibition, and adaptive decision-making. Each session lasts ~30 minutes.

Statistical Analysis

Sample size was calculated using G*Power for independent-sample t-tests, assuming a medium effect size (d = 0.5), a power of 95%, and an alpha level of 0.05. This yielded a requirement of 54 participants per group. To account for an estimated 10% dropout rate, the total sample size was increased to 120 participants (60 per group).

The primary outcome (number of traffic violations) will be analyzed using parametric or non-parametric tests, depending on the distribution and homogeneity of variance of the data.

Secondary outcomes will be analyzed as follows:

• Correlation analyses (Pearson or Spearman) to assess relationships between clinical and instrumental measures.
• Repeated measures ANOVA or Friedman tests for within-subject comparisons over time.
• Mixed-model ANOVA for analyzing training effects, with group as a between-subject factor and time as a within-subject factor.

Both statistical significance (p-values) and clinical relevance will be evaluated to interpret the results meaningfully.

ETHICAL CONSIDERATIONS

The study will follow the Declaration of Helsinki and GCP standards. Ethics approval has been obtained from the National Pediatric Ethics Committee. Participants will provide informed consent/assent. Risks are minimal and limited to possible simulator-related discomfort (e.g., motion sickness). Mitigation protocols and trained staff will ensure participants' safety.

POTENTIAL BENEFITS

While no direct clinical benefits are guaranteed, participants may gain greater awareness of their attentional functioning. The study will contribute to developing novel clinical tools for ADHD assessment and training, potentially improving treatment personalization and long-term outcomes in adolescents.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lino Nobili, MD PhD; Phone Number: +3901056262381; Email: linonobili@gaslini.org

Study Locations

• Italy
  • GE
    • Genoa, GE, Italy, 16147
      • Recruiting
      • IRCCS Istituto Giannina Gaslini
      • Contact: Lino Nobili, MD PhD; Phone Number: +3901056362381; Email: linonobili@gaslini.org
      • Principal Investigator: Lino Nobili, MD PhD
  • PI
    • Pisa, PI, Italy, 56128
      • Recruiting
      • IRCCS Fondazione Stella Maris
      • Contact: Antonio Narzisi, Psychologist, PhD; Phone Number: +393205690832; Email: antonio.narzisi@fsm.unipi.it
      • Principal Investigator: Antonio Narzisi, Psychologist, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ADHD Adolescents evaluation pre and post clinical standard treatment; 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.
No Intervention: Healthy controls; 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.
No Intervention: ADHD Adolescent without ADRIS Training; 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
Experimental: ADHD adolescents with ADRIS Training; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate differences in driving subjects (adolescents with / without ADHD)	Heart rate (HR) during driving task, measured using a wearable chest strap with heart rate sensor. Unit of measure: beats per minute (bpm) This measure is directly provided by the simulator	[Baseline - T0] Day 0
Heart rate variability differences in driving subjects (adolescents with / without ADHD)	Heart rate variability (HRV) during driving task, measured using a wearable chest strap with heart rate sensor. Calculated as mean and standard deviation of R-R intervals. Unit of measure: milliseconds (ms) This measure is directly provided by the simulator	[Baseline - T0] Day 0
Trunk movements differences in driving subjects (adolescents with/without ADHD)	Trunk movements on frontal and sagittal planes, extracted from stereo camera recordings. Unit of measure: degrees (°) This measure is directly provided by the simulator	[Baseline - T0] Day 0
Head direction differences in driving subjects (adolescents with/without ADHD)	Head direction (heading) during driving task, extracted from stereo camera recordings. Unit of measure: degrees (°) This measure is directly provided by the simulator	[Baseline - T0] Day 0
Cognitive assessment with Wechsler Scale in ADHD patients	Cognitive assessment will be performed depending on subjects' age with; Wechsler Intelligence Scale for Children - 4th Edition (WISC IV) [Total standard score, Perceptual Reasoning Index score, Block Design score, Picture Concepts score, Matrix Reasoning score, Working Memory Index score, Digit Span score, Letter-Number Sequencing score, Processing Speed Index score, Coding score, Symbol Search score, Cancellation score]; Wechsler Adult Intelligence Scale - 4th Edition (WAIS IV) [Total standard score, Perceptual Reasoning Index score, Block Design score, Visual Puzzles score, Matrix Reasoning score, Working Memory Index score, Digit Span score, Arithmetic score, Processing Speed Index score, Coding score, Symbol Search score, Cancellation score]	[Baseline - T0] Day 0
Behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients, as reported by their parents or primary caregivers.	Assessment will be performed through administration of the following questionnaire: Child Behavior CheckList (CBCL) Parent Form [Anxious/Depressed percentile score, Withdrawn/Depressed percentile score, Somatic Complaints percentile score, Social Problems percentile score, Thought Problems percentile score, Attention Problems percentile score, Rule-Breaking Behavior percentile score, Aggressive Behavior percentile score, Internalizing Problems percentile score, Externalizing Problems percentile score, Other Problems percentile score, Total Problems percentile score, Depressive Problems percentile score, Anxiety Problems percentile score, Somatic Problems percentile score, Attention Deficit/Hyperactivity percentile score, Oppositional Defiant Problems percentile score, Conduct Problems percentile score, Sluggish Cognitive Tempo percentile score, Obsessive-Compulsive Problems percentile score, Stress Problems percentile score]	[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Self reported behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients	Assessment will be performed through administration of the following questionnaire: Youth Self Report 11-18 Form [Anxious/Depressed percentile score, Withdrawn/Depressed percentile score, Somatic -Complaints percentile score, Social Problems percentile score, Thought Problems percentile score, Attention Problems percentile score, Rule-Breaking Behavior percentile score, Aggressive Behavior percentile score, Internalizing Problems percentile score, Externalizing Problems percentile score, Total Problems percentile score, Affective Problems percentile score, Anxiety Problems percentile score, Somatic Problems percentile score, Attention Deficit/Hyperactivity percentile score, Oppositional Defiant Problems percentile score, Conduct Problems percentile score, Stress Problems percentile score, Positive Qualities percentile score, Obsessive-Compulsive Problems percentile score]	[Baseline - T0] Day 0, [T1] Month 3, [T2] 6 weeks after [T0] or [T1]
Attention, behavior, and emotional regulation assessment in ADHD patients	Assessment will be performed through administration of the following questionnaires: Conners-3 Parent Form [ADHD Index score, Inattention percentile score, Hyperactivity/Impulsivity percentile score, Learning Problems percentile score, Executive Functioning percentile score, Defiance/Aggression percentile score, Peer Relations percentile score, Global Index T score]; Conners-3 Self Report Form [ADHD Index score, Inattention percentile score, Hyperactivity/Impulsivity percentile score, Learning Problems percentile score, Executive Functioning percentile score, Defiance/Aggression percentile score, Peer Relations percentile score, Global Index T score]	[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Visual-Motor Integration assessment in ADHD patients	Assessment will be performed through administration of the following: Developmental Test of Visual-Motor Integration [Total standard score, Total scaled score, Visual standard score, Visual scaled score, Motor standard score, Motor scaled score]	[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Sustained and selective attention assessment in ADHD patients	Assessment will be performed through administration of the following: - NEPSY II (A Developmental Neuropsychological Assessment - Second Edition) [Auditory Attention total percentile score, Response Set total percentile score, Naming Attention Time scaled score, Naming Total Errors percentile score, Naming Combination scaled score, Inhibition Attention Time scaled score, Inhibition Total Errors percentile score, Inhibition Combination scaled score, Switching Attention Time scaled score, Switching Total Errors percentile score, Switching Combination scaled score]	[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Inhibitory control and cognitive interference assessment in ADHD patients	Assessment will be performed through administration of the following: Stroop Test [Color Naming score, Incongruent Naming score, Corrected score, Equivalent score]	[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]

Collaborators and Investigators

• Sponsor: Istituto Giannina Gaslini
• Collaborators: University of Genova; IRCCS Fondazione Stella Maris
• Investigators: Principal Investigator: Lino Nobili, MD PhD, IRCCS Istituto Giannina Gaslini

Publications and helpful links

General Publications

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• Epstein JN, Garner AA, Kiefer AW, Peugh J, Tamm L, MacPherson RP, Simon JO, Fisher DL. Trial of Training to Reduce Driver Inattention in Teens with ADHD. N Engl J Med. 2022 Dec 1;387(22):2056-2066. doi: 10.1056/NEJMoa2204783.
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• R. A. Barkley, K. R. Murphy, and D. Kwasnik, "Motor vehicle driving competencies and risks in teens and young adults with attention deficit hyperactivity disorder," Pediatrics, vol. 98, no. 6 Pt 1, pp. 1089-1095, Dec. 1996, Accessed: Dec. 01, 2023.
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• M. J. Groom, E. van Loon, D. Daley, P. Chapman, and C. Hollis, "Driving behaviour in adults with attention deficit/hyperactivity disorder," BMC Psychiatry, vol. 15, no. 1, Jul. 2015, doi: https://doi.org/10.1186/s12888-015-0566-y.
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• Pezzuti, L., Barbaranelli, C., & Orsini, A. (2012). Structure of the Wechsler Adult Intelligence Scale-Revised in the Italian Normal Standardisation Sample. Journal of Cognitive Psychology, 24(2), 229-241.
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Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 5, 2025
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; Driving simulator
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: ADRIS-ADHD; Fit for Medical Robotics (Other Identifier: Piano nazionale per gli investimenti complementari al Piano nazionale di ripresa e resilienza)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No