Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trials

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ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
IRCCS Istituto Giannina Gaslini
RECRUITING
Genoa
IRCCS Fondazione Stella Maris
RECRUITING
Pisa
Contact Information
Primary
Lino Nobili, MD PhD
linonobili@gaslini.org
+3901056262381
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2028-01
Participants
Target number of participants: 120
Treatments
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)
Sponsors
Collaborators: IRCCS Fondazione Stella Maris, University of Genova
Leads: Istituto Giannina Gaslini

This content was sourced from clinicaltrials.gov