[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629729":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":75,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":28,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":12,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Istituto Giannina Gaslini","OTHER",[8,13,16,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"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-\u002Fpost- ADRIS driving training assessments.",{"label":17,"type":10,"description":18,"interventionNames":12},"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",{"label":20,"type":21,"description":22,"interventionNames":23},"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)",[24],"Device: ADRIS-ADHD",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"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.",[20],[32],{"name":33,"affiliation":34,"role":35},"Lino Nobili, MD PhD","IRCCS Istituto Giannina Gaslini","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":12,"email":40},"CONTACT","+3901056262381","linonobili@gaslini.org",[42,59],{"facility":34,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Genoa","GE","16147","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],8.94439,44.40478,{"lat":53,"lon":52},[56,58],{"name":33,"role":38,"phone":57,"phoneExt":12,"email":40},"+3901056362381",{"name":33,"role":35,"phone":12,"phoneExt":12,"email":12},{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"IRCCS Fondazione Stella Maris","Pisa","PI","56128",{"type":50,"coordinates":65},[66,67],10.4036,43.70853,{"lat":67,"lon":66},[70,74],{"name":71,"role":38,"phone":72,"phoneExt":12,"email":73},"Antonio Narzisi, Psychologist, PhD","+393205690832","antonio.narzisi@fsm.unipi.it",{"name":71,"role":35,"phone":12,"phoneExt":12,"email":12},{"type":76,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[78,79],{"name":60,"class":6},{"name":80,"class":6},"University of Genova","100629729","adris-driving-simulator-for-adolescents-with-attention-deficit-and-hyperactivity-disorder-100629729",false,"NCT07478458","ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder","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)\u002Fguardian(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\u002Fcorrectable with the normal use of lenses.\n* Motor deficits clinically detected and\u002For 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 \u002F withddrawal of consent to the protocol",true,"ALL","13 Years","18 Years",{"count":92,"type":93},120,"ESTIMATED","INTERVENTIONAL",[96],"NA","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.",[99],"ADHD - Attention Deficit Disorder With Hyperactivity",[101,102],"ADHD","Driving simulator","2026-03-13",{"date":105,"type":106},"2026-03-17","ACTUAL",{"date":108,"type":106},"2025-11-10",{"date":110,"type":93},"2028-01",{"name":5,"class":6},2]