ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorIstituto Giannina Gaslini
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ADRIS-ADHD
Device30 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.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: ADHD Adolescents evaluation pre and post clinical standard treatmentNo intervention 0 interventions
Group B: Healthy controlsNo intervention 0 interventions
Group C: ADHD Adolescent without ADRIS TrainingNo intervention 0 interventions
Group D: ADHD adolescents with ADRIS TrainingExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
[Baseline - T0] Day 0Secondary outcomes
1
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
Time frame
[Baseline - T0] Day 02
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
Time frame
[Baseline - T0] Day 03
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
Time frame
[Baseline - T0] Day 04
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
Time frame
[Baseline - T0] Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Giannina Gaslini
Lead sponsor
IRCCS Fondazione Stella Maris
Collaborator
University of Genova
Collaborator
Source ClinicalTrials.gov