Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children

Study Overview
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Brief Summary
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Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game. Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older. Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.

Official Title
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Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Device: ARVO 2.0 WEB
* Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD group The Inclusion criteria: Signed informed consent (by guardian and a child) Age of 8-13 at the time of consent ADHD set by a licensed physician Native language Finnish / Fluent Finnish language TD group The Inclusion criteria: Signed informed consent (by guardian and child) Age of 8-13 at the time of the consent Native language Finnish / Fluent Finnish language Exclusion Criteria: ADHD group Any diseases of the nervous system (ICD-10, G00-G99) Mental and behavioural disorders due to psychoactive substance use (F10-F19) Schizophrenia, schizotypal and delusional disorders (F20 - F29) Acute severe depression or mania / hypomania (F30, F32, F33) Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42) Severe mental retardation (F72) Disorders of psychological development (F80, F81, F83, F84) Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out) Atomoxetine, guanfacine Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision) Diagnosis search completeness criteria: Diagnosis present/absent in patient registry Kanta. TD group Set ADHD diagnosis. Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire. Any diseases of the nervous system (ICD-10, G00-G99) Mental and behavioural disorders due to psychoactive substance use (F10-F19) Schizophrenia, schizotypal and delusional disorders (F20 - F29) Acute severe depression or mania / hypomania (F30, F32, F33) Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42) Severe mental retardation (F72) Disorders of psychological development (F80, F81, F83, F84) Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, interventional, case control clinical investigation. Comparison of groups. Equivalence study. Intervention model: cross-over assignment both groups are given both ARVO and Conners Continuous Performance Test 3rd Edition™ (CPT 3) tests. Allocation: Propensity matching is used to ensure inter-group homogeneity in background variable with possible interaction effect to ARVO and CPT 3 score. Propensity matching: age and sex.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD<br>Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed) | Device: ARVO 2.0 WEB<br>* Medical device software where the subject navigates in a virtual apartment, with the goal of performing the tasks given by a cartoon dragon character. The child is asked to perform the subtasks in the given order, except for the subtasks to be completed at a certain time or after a certain sound cue, but the completion order does not influence the scoring. One task scenario lasts until all subtasks are correctly performed or until the time limit of 60 s is reached. The classification whether the subject belong to typically developed population is based on quantitative neurological performance indicators produced during the game. However, even if the activity performed is differential diagnostics, ARVO does not create any medical diagnosis. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed.<br>Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)<br>* Subjects are required to respond by pressing the spacebar or the appropriate key on the mouse when any letter other than the letter X appears on the monitor. The Conners CPT 3 presents 14-minute, 360 scored stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 sec. between the presentation of letters (i.e., the interstimulus interval; ISI). The 360 trials are divided into 6 blocks, with 3 sub-blocks each consisting of 20 trials. Each block lasts approximately 2 min and 20 sec. Scores and Score Dimensions of Attention Measured: Inattentiveness, Impulsivity, Sustained Attention and Vigilance. The Conners CPT 3 produces computer-generated reports that describe the respondent's performance. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed<br>|
| Experimental: ADHD<br>Children of 8-13 years of age with previously diagnosed ADHD symptoms | Device: ARVO 2.0 WEB<br>* Medical device software where the subject navigates in a virtual apartment, with the goal of performing the tasks given by a cartoon dragon character. The child is asked to perform the subtasks in the given order, except for the subtasks to be completed at a certain time or after a certain sound cue, but the completion order does not influence the scoring. One task scenario lasts until all subtasks are correctly performed or until the time limit of 60 s is reached. The classification whether the subject belong to typically developed population is based on quantitative neurological performance indicators produced during the game. However, even if the activity performed is differential diagnostics, ARVO does not create any medical diagnosis. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed.<br>Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)<br>* Subjects are required to respond by pressing the spacebar or the appropriate key on the mouse when any letter other than the letter X appears on the monitor. The Conners CPT 3 presents 14-minute, 360 scored stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 sec. between the presentation of letters (i.e., the interstimulus interval; ISI). The 360 trials are divided into 6 blocks, with 3 sub-blocks each consisting of 20 trials. Each block lasts approximately 2 min and 20 sec. Scores and Score Dimensions of Attention Measured: Inattentiveness, Impulsivity, Sustained Attention and Vigilance. The Conners CPT 3 produces computer-generated reports that describe the respondent's performance. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARVO and CPT 3 neuropsychiatric indicators (NPIs) | To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC) | At Visit 1 test event (four weeks after V0 enrollment) | 
| Children SSQ score | To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2. | At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARVO and CPT 3 neuropsychiatric indicators (NPIs) | To confirm that ARVO is equivalent to CPT 3 regarding individual NPIs ability to differentiate ADHD and TD groups | Visit 1 test event (four weeks after V0 enrollment) | 
| ARVO NPIs mean score and ADHR-RS for parent score | To confirm that ARVO is equivalent to ADHD-RS regarding concurrent validity (correlation) | Visit 1 test event (four weeks after V0 enrollment) | 
| Smileyometer and Fun Sorter | To confirm that ARVO is superior to CPT 3 regarding use experience | Visit 1 test event (four weeks after V0 enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD