Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:34 AM
Study NCT ID:
NCT07478458
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nIn 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.\n\nIn 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attention assessment in adolescents with / without ADHD using ADRIS driving simulator', 'timeFrame': '[Baseline - T0] Day 0', 'description': '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:\n\n* ignored stop signs (N)\n* ignored red lights (N)\n* collisions (N)\n* wrong way driving (N)\n* speed limits ignored (N)\n* ignored safety distance (N). These measures are directly provided by the simulator). Unit of measure: count (N)'}], 'secondaryOutcomes': [{'measure': 'Heart rate differences in driving subjects (adolescents with / without ADHD)', 'timeFrame': '[Baseline - T0] Day 0', 'description': 'Heart rate (HR) during driving task, measured using a wearable chest strap with heart rate sensor.\n\nUnit of measure: beats per minute (bpm) This measure is directly provided by the simulator'}, {'measure': 'Heart rate variability differences in driving subjects (adolescents with / without ADHD)', 'timeFrame': '[Baseline - T0] Day 0', 'description': '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.\n\nUnit of measure: milliseconds (ms) This measure is directly provided by the simulator'}, {'measure': 'Trunk movements differences in driving subjects (adolescents with/without ADHD)', 'timeFrame': '[Baseline - T0] Day 0', 'description': 'Trunk movements on frontal and sagittal planes, extracted from stereo camera recordings.\n\nUnit of measure: degrees (°) This measure is directly provided by the simulator'}, {'measure': 'Head direction differences in driving subjects (adolescents with/without ADHD)', 'timeFrame': '[Baseline - T0] Day 0', 'description': 'Head direction (heading) during driving task, extracted from stereo camera recordings.\n\nUnit of measure: degrees (°) This measure is directly provided by the simulator'}, {'measure': 'Cognitive assessment with Wechsler Scale in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0', 'description': "Cognitive assessment will be performed depending on subjects' age with\n\n* 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\\]\n* 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\\]"}, {'measure': 'Behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients, as reported by their parents or primary caregivers.', 'timeFrame': '[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following questionnaire:\n\nChild 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\\]'}, {'measure': 'Self reported behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0, [T1] Month 3, [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following questionnaire:\n\nYouth 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\\]'}, {'measure': 'Attention, behavior, and emotional regulation assessment in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following questionnaires:\n\n* 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\\]\n* 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\\]'}, {'measure': 'Visual-Motor Integration assessment in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following:\n\nDevelopmental Test of Visual-Motor Integration \\[Total standard score, Total scaled score, Visual standard score, Visual scaled score, Motor standard score, Motor scaled score\\]'}, {'measure': 'Sustained and selective attention assessment in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following:\n\n\\- 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\\]'}, {'measure': 'Inhibitory control and cognitive interference assessment in ADHD patients', 'timeFrame': '[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]', 'description': 'Assessment will be performed through administration of the following:\n\nStroop Test \\[Color Naming score, Incongruent Naming score, Corrected score, Equivalent score\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Driving simulator'], 'conditions': ['ADHD - Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Posner J, Polanczyk GV, Sonuga-Barke E. Attention-deficit hyperactivity disorder. Lancet. 2020 Feb 8;395(10222):450-462. doi: 10.1016/S0140-6736(19)33004-1. Epub 2020 Jan 23. PMID: 31982036; PMCID: PMC7880081.'}, {'type': 'BACKGROUND', 'citation': 'Miyake A., Friedman N.P e Emerson M.J. (2000), The unity and diversity of Executive Functions and their contributions to complex Frontal Lobe Tasks: a latent variable analysis, "Cognitive Psychology", vol. 41, n. 1, pp. 49-100.'}, {'type': 'BACKGROUND', 'citation': 'Miyake A, Friedman NP (2004), The relationship among inhibition and interference cognitive functions: a latent variable analysis. J Exp Psychol Gen 133:101-135'}, {'type': 'BACKGROUND', 'citation': 'Miyake A, Friedman NP (2012), The nature and organization of individual differences in executive functions: four general conclusions. Curr Dir Psychol Sci 21(1):8-14'}, {'type': 'BACKGROUND', 'citation': 'A. B. M. Fuermaier et al., "Driving and attention deficit hyperactivity disorder," Journal of Neural Transmission, vol. 124, no. S1, pp. 55-67, Sep. 2015.'}, {'type': 'BACKGROUND', 'citation': 'L. Steinberg, "Cognitive and affective development in adolescence," Trends in Cognitive Sciences, vol. 9, no. 2, pp. 69-74, Feb. 2005.'}, {'type': 'BACKGROUND', 'citation': 'R. A. Barkley, "Behavioral inhibition, sustained attention, and executive functions: Constructing a unifying theory of ADHD.," Psychological Bulletin, vol. 121, no. 1, pp. 65-94, Jan. 1997, doi: https://doi.org/10.1037/0033-2909.121.1.65'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'J. Biederman et al., "A laboratory driving simulation for assessment of driving behavior in adults with ADHD: a controlled study," Annals of General Psychiatry, vol. 6, no. 1, Jan. 2007, doi: https://doi.org/10.1186/1744-859x-6-4.'}, {'type': 'BACKGROUND', 'citation': 'R. Fried et al., "Characterizing Impaired Driving in Adults With Attention-Deficit/Hyperactivity Disorder," The Journal of Clinical Psychiatry, vol. 67, no. 04, pp. 567-574, Apr. 2006, doi: https://doi.org/10.4088/jcp.v67n0407.'}, {'type': 'BACKGROUND', 'citation': 'R. L. Merkel et al., "Comparison of On-Road Driving Between Young Adults With and Without ADHD," Journal of Attention Disorders, vol. 20, no. 3, pp. 260-269, Feb. 2013, doi: https://doi.org/10.1177/1087054712473832'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'S. G. Hart and L. E. Staveland, "Development of NASA-TLX (Task Load Index): Results of Empirical and Theoretical Research," ScienceDirect, Jan. 01, 1988.'}, {'type': 'BACKGROUND', 'citation': 'R. S. Kennedy, N. E. Lane, K. S. Berbaum, and M. G. Lilienthal, "Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness," tps://doi.org/10.1207/s15327108ijap0303_3, vol. 3, no. 3, pp. 203-220, 2009, doi: 10.1207/S15327108IJAP0303_3.'}, {'type': 'BACKGROUND', 'citation': 'Wechsler, D. (2003). WISC-IV. Wechsler Intelligence Scale for Children - Fourth Edition Technical and Interpretive Manual. San Antonio, TX: The Psychological Association.'}, {'type': 'BACKGROUND', 'citation': 'C. W. Eriksen and D. W. Schultz, "Information processing in visual search: A continuous flow conception and experimental results," Perception & Psychophysics, vol. 25, no. 4, pp. 249-263, Jul. 1979, doi: https://doi.org/10.3758/bf03198804.'}, {'type': 'BACKGROUND', 'citation': 'J. R. Stroop, "Studies on interference in serial verbal reactions," Journal of experimental psychology, 1933.'}, {'type': 'BACKGROUND', 'citation': 'M. I. Posner, "Orienting of attention," Quarterly Journal of Experimental Psychology, vol. 32, no. 1, pp. 3-25, Feb. 1980, doi: https://doi.org/10.1080/00335558008248231.'}, {'type': 'BACKGROUND', 'citation': 'Wechsler, D. (2008). WAIS-IV: Wechsler Adult Intelligence Scale. San Antonio, TX: Pearson.'}, {'type': 'BACKGROUND', 'citation': 'Korkman, M., Kirk, U., Kemp, S. (2007). NEPSY-II: Clinical and interpretative manual. San Antonio, TX: Harcourt Assessment (ed. it.: a cura di C. Urgesi, F. Campanella e F. Fabbro, 2011).'}, {'type': 'BACKGROUND', 'citation': 'Beery K.E. (2004), The Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI-5), Minneapolis, MN, NCS Pearson.'}, {'type': 'BACKGROUND', 'citation': "Test di Stroop: Dati normativi italiani di una versione cartacea per l'uso clinico / S., Valgimigli; R., Padovani; Budriesi, Carla; M. E., Leone; D., Lugli; Nichelli, Paolo Frigio. - In: GIORNALE ITALIANO DI PSICOLOGIA. - ISSN 0390-5349. STAMPA. - 37:(2010), pp. 945-953."}, {'type': 'BACKGROUND', 'citation': 'Ivanova MY, Achenbach TM, Rescorla LA. The Generalizability of the Youth Self-Report Syndrome Structure in 23 Societies. J Consult Clin Psych. 2007; 75:729-738.'}, {'type': 'BACKGROUND', 'citation': 'Conners, C. K. (2008, 2009). Conners 3rd edition manual. Toronto: Multi-Health Systems.'}, {'type': 'BACKGROUND', 'citation': 'Achenbach TM, Rescorla LA. Manual for the ASEBA School- Age Forms & Profiles, University of Vermont, Research Center for Children, Youth, & Families, Burlington, 2001.'}, {'type': 'BACKGROUND', 'citation': 'K. M. Kingery, M. Narad, A. A. Garner, T. N. Antonini, L. Tamm, and J. N. Epstein, "Extended Visual Glances Away from the Roadway are Associated with ADHD- and Texting-Related Driving Performance Deficits in Adolescents," Journal of Abnormal Child Psychology, vol. 43, no. 6, pp. 1175-1186, Nov. 2014, doi: https://doi.org/10.1007/s10802-014-9954-x.'}, {'type': 'BACKGROUND', 'citation': 'Linee Guida SINPIA, giugno 2002, Linee-guida per la diagnosi e la terapia farmacologica del Disturbo da Deficit Attentivo con Iperattività (ADHD) in età evolutiva.'}, {'type': 'BACKGROUND', 'citation': 'A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016 Mar 19;387(10024):1240-50. doi: 10.1016/S0140- 6736(15)00238-X. Epub 2015 Sep 17. PMID: 26386541.'}, {'pmid': '26386541', 'type': 'BACKGROUND', 'citation': 'Thapar A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016 Mar 19;387(10024):1240-50. doi: 10.1016/S0140-6736(15)00238-X. Epub 2015 Sep 17.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'R. S. Kennedy, N. E. Lane, K. S. Berbaum, and M. G. Lilienthal, "Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness," https://doi.org/10.1207/s15327108ijap0303_3, vol. 3, no. 3, pp. 203-220, 2009, doi: 10.1207/S15327108IJAP0303_3.'}, {'pmid': '15243010', 'type': 'BACKGROUND', 'citation': 'Cox DJ, Humphrey JW, Merkel RL, Penberthy JK, Kovatchev B. Controlled-release methylphenidate improves attention during on-road driving by adolescents with attention-deficit/hyperactivity disorder. J Am Board Fam Pract. 2004 Jul-Aug;17(4):235-9. doi: 10.3122/jabfm.17.4.235.'}, {'pmid': '10790000', 'type': 'BACKGROUND', 'citation': 'Cox DJ, Merkel RL, Kovatchev B, Seward R. Effect of stimulant medication on driving performance of young adults with attention-deficit hyperactivity disorder: a preliminary double-blind placebo controlled trial. J Nerv Ment Dis. 2000 Apr;188(4):230-4. doi: 10.1097/00005053-200004000-00006.'}, {'pmid': '30097390', 'type': 'BACKGROUND', 'citation': 'Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, Atkinson LZ, Tessari L, Banaschewski T, Coghill D, Hollis C, Simonoff E, Zuddas A, Barbui C, Purgato M, Steinhausen HC, Shokraneh F, Xia J, Cipriani A. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018 Sep;5(9):727-738. doi: 10.1016/S2215-0366(18)30269-4. Epub 2018 Aug 7.'}, {'pmid': '36449421', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Klauer C, Ollendick TH, Ankem G,vDingus TA. Improving driving safety for teenagers with attention deficit and hyper- activity disorder (ADHD). Virginia Tech, September 19, 2017'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nParticipants 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.\n\nThe 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.\n\nThe results may help inform future clinical evaluations and support tools for adolescents with ADHD, with the potential to improve safety and quality of life.', 'detailedDescription': 'INTRODUCTION\n\nAttention 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.\n\nTraditional 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.\n\nRATIONALE OF THE STUDY\n\nThis 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.\n\nUnlike 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.\n\nThe 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.\n\nDEVICE DESCRIPTION\n\nADRIS 2.1 is a driving simulator composed of the following components:\n\n* Steering wheel and pedals connected to a PlayStation console\n* 32" monitor displaying high-resolution driving environments\n* Integrated camera system for tracking head and torso movements\n* Heart rate monitor positioned on the left pectoral area\n\nThe system is supported by software developed on the Unreal Engine platform, designed to:\n\n* Generate realistic urban and suburban driving scenarios\n* Provide interactive navigation with auditory guidance\n* Present neutral, congruent, and incongruent visual stimuli to test attentional control\n* Acquire and analyze metrics such as lane crossing, reaction time, speed variability, and physiological responses\n\nSTUDY OBJECTIVES\n\nPrimary Objective:\n\nCompare 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.\n\nSecondary Objectives:\n\n* Analyze body movement and heart rate data to assess physiological and behavioral differences during driving tasks\n* Correlate simulator performance with standardized neuropsychological test results\n* Monitor intra-individual changes over time (baseline vs. follow-up) to assess the impact of clinical treatments\n* Evaluate the effect of repeated ADRIS-based training on driving behavior and attentional control in a randomized subgroup\n\nPARTICIPANTS\n\nA 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.\n\nSTUDY PROCEDURES\n\nT0 (All participants):\n\nADHD group: full neuropsychological battery, standardized questionnaires (e.g., WISC/WAIS, NEPSY-II, CBCL, CONNERS 3), first ADRIS session (6 driving scenarios)\n\nControl group: short screening questionnaire, ADRIS simulator session (same protocol)\n\nT1 (ADHD only):\n\nAt 3 months: repeat ADRIS session and neuropsychological assessments (excluding cognitive battery)\n\nT2 Sub-study (ADHD only):\n\n30 ADHD participants will be randomized into two age- and sex-matched groups:\n\nTraining group: 12 simulator training sessions over 6 weeks\n\nControl group: no training\n\nBoth subgroups will undergo pre- and post-training ADRIS testing and neuropsychological evaluation (excluding cognitive battery)\n\nSTIMULI AND TASK DESIGN\n\nDuring simulator sessions, participants will encounter:\n\n* Neutral stimuli: non-threatening static obstacles (e.g., trash bins)\n* Congruent stimuli: dynamic, context-appropriate obstacles (e.g., pedestrian crossing)\n* Incongruent stimuli: misleading cues followed by sudden hazards (e.g., decoy pedestrian followed by car)\n\nThese scenarios test attentional capture, inhibition, and adaptive decision-making. Each session lasts \\~30 minutes.\n\nStatistical Analysis\n\nSample 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).\n\nThe 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.\n\nSecondary outcomes will be analyzed as follows:\n\n* Correlation analyses (Pearson or Spearman) to assess relationships between clinical and instrumental measures.\n* Repeated measures ANOVA or Friedman tests for within-subject comparisons over time.\n* Mixed-model ANOVA for analyzing training effects, with group as a between-subject factor and time as a within-subject factor.\n\nBoth statistical significance (p-values) and clinical relevance will be evaluated to interpret the results meaningfully.\n\nETHICAL CONSIDERATIONS\n\nThe 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.\n\nPOTENTIAL BENEFITS\n\nWhile 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for ADHD subjects:\n\n* Age range 13-18 years (up to the age of nineteen)\n* Diagnosis of ADHD (hyperactive, inattentive and combined subtype)\n* Consent to participate in the study by the participant or, in the case of a minor, by their parent(s)/guardian(s).\n\nInclusion Criteria for Control Group subjects:\n\n* Age- and sex-matched neurotypical adolescents\n* No diagnosis of ADHD or other neurodevelopmental disorders\n* Informed consent obtained from the participant if of legal age or from the legal guardian and assent from the minor\n\nExclusion Criteria:\n\n* Visual deficits not corrected/correctable with the normal use of lenses.\n* Motor deficits clinically detected and/or previously diagnosed and that could compromise the use of the simulator (e.g. neurological diseases, psychiatric diseases, etc.).\n* Categorical diagnoses according to DSM-5 criteria such as Psychosis, Mood Disorders, Autism Spectrum Disorders, Intellectual Disabilities, Borderline Intellectual Functioning, Anxiety Disorders.\n* Patients with other conditions that could affect driving ability.\n* Denial / withddrawal of consent to the protocol'}, 'identificationModule': {'nctId': 'NCT07478458', 'acronym': 'ADRIS-ADHD', 'briefTitle': 'ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Giannina Gaslini'}, 'officialTitle': 'ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'ADRIS-ADHD'}, 'secondaryIdInfos': [{'id': 'Fit for Medical Robotics', 'type': 'OTHER', 'domain': 'Piano nazionale per gli investimenti complementari al Piano nazionale di ripresa e resilienza'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'ADHD Adolescents evaluation pre and post clinical standard treatment', 'description': '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.'}, {'type': 'NO_INTERVENTION', 'label': 'Healthy controls', 'description': '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.'}, {'type': 'NO_INTERVENTION', 'label': 'ADHD Adolescent without ADRIS Training', 'description': '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'}, {'type': 'EXPERIMENTAL', 'label': 'ADHD adolescents with ADRIS Training', 'description': '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)', 'interventionNames': ['Device: ADRIS-ADHD']}], 'interventions': [{'name': 'ADRIS-ADHD', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['ADHD adolescents with ADRIS Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16147', 'city': 'Genoa', 'state': 'GE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lino Nobili, MD PhD', 'role': 'CONTACT', 'email': 'linonobili@gaslini.org', 'phone': '+3901056362381'}, {'name': 'Lino Nobili, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Giannina Gaslini', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '56128', 'city': 'Pisa', 'state': 'PI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Narzisi, Psychologist, PhD', 'role': 'CONTACT', 'email': 'antonio.narzisi@fsm.unipi.it', 'phone': '+393205690832'}, {'name': 'Antonio Narzisi, Psychologist, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Fondazione Stella Maris', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Lino Nobili, MD PhD', 'role': 'CONTACT', 'email': 'linonobili@gaslini.org', 'phone': '+3901056262381'}], 'overallOfficials': [{'name': 'Lino Nobili, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Giannina Gaslini'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Giannina Gaslini', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS Fondazione Stella Maris', 'class': 'OTHER'}, {'name': 'University of Genova', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}