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ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder

NCT07478458, Not applicable, Recruiting, Istituto Giannina Gaslini

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity DisorderClinicalTrials.gov
NCT numberNCT07478458ClinicalTrials.gov
StatusRecruitingClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment120 participants, estimatedClinicalTrials.gov
Lead sponsorIstituto Giannina GasliniClinicalTrials.gov
ConditionsADHD - Attention Deficit Disorder With HyperactivityClinicalTrials.gov
InterventionsADRIS-ADHDClinicalTrials.gov
First posted2026-03-17ClinicalTrials.gov
Last updated2026-03-17ClinicalTrials.gov

Registered outcomes 12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryAttention assessment in adolescents with / without ADHD using ADRIS driving simulator[Baseline - T0] Day 0
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)
ClinicalTrials.gov
SecondaryHeart rate differences in driving subjects (adolescents with / without ADHD)[Baseline - T0] Day 0Heart 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 simulatorClinicalTrials.gov
SecondaryHeart rate variability differences in driving subjects (adolescents with / without ADHD)[Baseline - T0] Day 0
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
ClinicalTrials.gov
SecondaryTrunk movements differences in driving subjects (adolescents with/without ADHD)[Baseline - T0] Day 0Trunk movements on frontal and sagittal planes, extracted from stereo camera recordings. Unit of measure: degrees (°) This measure is directly provided by the simulatorClinicalTrials.gov
SecondaryHead direction differences in driving subjects (adolescents with/without ADHD)[Baseline - T0] Day 0Head direction (heading) during driving task, extracted from stereo camera recordings. Unit of measure: degrees (°) This measure is directly provided by the simulatorClinicalTrials.gov
SecondaryCognitive assessment with Wechsler Scale in ADHD patients[Baseline - T0] Day 0
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) \[Total standard score, Perceptual Reasoning Index score, Block Design score, Visual Puzzles score, Matrix Reasoning score, Working Memory Index score, Digit Span score, Arithmetic score, Processing Speed Index score, Coding score, Symbol Search score, Cancellation score\]
ClinicalTrials.gov
SecondaryBehavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients, as reported by their parents or primary caregivers.[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Assessment will be performed through administration of the following questionnaire: Child Behavior CheckList (CBCL) Parent Form \[Anxious/Depressed percentile score, Withdrawn/Depressed percentile score, Somatic Complaints percentile score, Social Problems percentile score, Thought Problems percentile score, Attention Problems percentile score, Rule-Breaking Behavior percentile score, Aggressive Behavior percentile score, Internalizing Problems percentile score, Externalizing Problems percentile score, Other Problems percentile score, Total Problems percentile score, Depressive Problems percentile score, Anxiety Problems percentile score, Somatic Problems percentile score, Attention Deficit/Hyperactivity percentile score, Oppositional Defiant Problems percentile score, Conduct Problems percentile score, Sluggish Cognitive Tempo percentile score, Obsessive-Compulsive Problems percentile score, Stress Problems percentile score\]
ClinicalTrials.gov
SecondarySelf reported behavior, adaptive skills and emotional-behavioral difficulties assessment in ADHD patients[Baseline - T0] Day 0, [T1] Month 3, [T2] 6 weeks after [T0] or [T1]
Assessment will be performed through administration of the following questionnaire: Youth Self Report 11-18 Form \[Anxious/Depressed percentile score, Withdrawn/Depressed percentile score, Somatic -Complaints percentile score, Social Problems percentile score, Thought Problems percentile score, Attention Problems percentile score, Rule-Breaking Behavior percentile score, Aggressive Behavior percentile score, Internalizing Problems percentile score, Externalizing Problems percentile score, Total Problems percentile score, Affective Problems percentile score, Anxiety Problems percentile score, Somatic Problems percentile score, Attention Deficit/Hyperactivity percentile score, Oppositional Defiant Problems percentile score, Conduct Problems percentile score, Stress Problems percentile score, Positive Qualities percentile score, Obsessive-Compulsive Problems percentile score\]
ClinicalTrials.gov
SecondaryAttention, behavior, and emotional regulation assessment in ADHD patients[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
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 \[ADHD Index score, Inattention percentile score, Hyperactivity/Impulsivity percentile score, Learning Problems percentile score, Executive Functioning percentile score, Defiance/Aggression percentile score, Peer Relations percentile score, Global Index T score\]
ClinicalTrials.gov
SecondaryVisual-Motor Integration assessment in ADHD patients[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Assessment will be performed through administration of the following: Developmental Test of Visual-Motor Integration \[Total standard score, Total scaled score, Visual standard score, Visual scaled score, Motor standard score, Motor scaled score\]
ClinicalTrials.gov
SecondarySustained and selective attention assessment in ADHD patients[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]
Assessment will be performed through administration of the following: \- NEPSY II (A Developmental Neuropsychological Assessment - Second Edition) \[Auditory Attention total percentile score, Response Set total percentile score, Naming Attention Time scaled score, Naming Total Errors percentile score, Naming Combination scaled score, Inhibition Attention Time scaled score, Inhibition Total Errors percentile score, Inhibition Combination scaled score, Switching Attention Time scaled score, Switching Total Errors percentile score, Switching Combination scaled score\]
ClinicalTrials.gov
SecondaryInhibitory control and cognitive interference assessment in ADHD patients[Baseline - T0] Day 0 [T1] Month 3 [T2] 6 weeks after [T0] or [T1]Assessment will be performed through administration of the following: Stroop Test \[Color Naming score, Incongruent Naming score, Corrected score, Equivalent score\]ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 21

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
461085BACKGROUNDPubMed
7367577BACKGROUNDPubMed
8951258BACKGROUNDPubMed
9000892BACKGROUNDPubMed
10790000BACKGROUNDPubMed
10945922BACKGROUNDPubMed
14979754BACKGROUNDPubMed
15243010BACKGROUNDPubMed
15668099BACKGROUNDPubMed
16669721BACKGROUNDPubMed
17263888BACKGROUNDPubMed
17907855BACKGROUNDPubMed
22773897BACKGROUNDPubMed
23400213BACKGROUNDPubMed
25416444BACKGROUNDPubMed
26216345BACKGROUNDPubMed
26386541BACKGROUNDPubMed
26419597BACKGROUNDPubMed
30097390BACKGROUNDPubMed
31982036BACKGROUNDPubMed

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Digit Span TestSecondary outcomeConductCognition
Letter-Number Sequencing TaskSecondary outcomeConductCognition
Matrix ReasoningSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Symbol Scan TaskSecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)