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Digital Epidemiology Study on Brain Functioning (EPIDIA4Kids)

Primary Purpose

Child Development, Child Development Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
O-Kidia game battery
O-Brain
Sponsored by
O-Kidia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Child Development focused on measuring Digital Epidemiology, Child, Neurodevelopment, Neurodevelopmental disorders, Mental disorders

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Boys or girls
  • Aged 7 to 12 years
  • Fluent in the French language
  • Agreement and signature of informed consent by the child
  • Agreement and signature of informed consent by one of the legal representatives
  • Estimated intelligence quotient > 85

Exclusion Criteria:

  • No biological parent or legal guardian is able to give permission for the minor and agrees to participate in parental assessments
  • Prematurity or other perinatal complications that required significant intervention
  • History of neurological disorders, including seizure disorders, cerebral palsy, or other conditions requiring neurological or medical care :

  • History of head injury:

    • Head trauma more than one year old with loss of consciousness >30 minutes, OR
    • Had to be hospitalized for head trauma, OR
    • Amnesia > 24 hours, OR
    • Confusion or loss of orientation >24 hours, OR
    • A brain scan revealed problems following a head injury, OR
    • Head trauma within the past year with loss of consciousness >10 minutes. Current or persistent major Axis I psychiatric disorder that may interfere with successful completion of the protocol (e.g., psychosis and bipolar disorder), or substance use disorder.

Current use of medications with significant effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); Attention Deficit Hyperactivity Disorder (ADHD) medications and Selective Serotonin Reuptake Inhibitors (SSRIs) are not excluded as the use of these medications is associated with certain neurodevelopmental disorders and assessment of these individuals will provide useful data to the community Not fluent in French (all youth materials are in French) Uncorrectable visual, hearing, or sensorimotor impairment, as the protocol items may not be valid.

Sites / Locations

  • O-KidiaRecruiting
  • Association la Busserine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

O-Kidia battery

Arm Description

A one-time visit will be performed in children aged 7 to 12 years old as follow : Children will be playing on a series of games with a touch screen tablet while video, EEGs and digit trajectories data will be collected from this mobile device Video recording of the participants during the tablet testing via the intrinsic camera - 30 min Assessments - Paper and tablet psychometric tests will be used during the administrations, 1h45 Child health questionnaires - Questionnaires will be completed by children and parents during the visit, 20 min for each

Outcomes

Primary Outcome Measures

Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Total errors, Number of errors in total, False responses
Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet False responses
Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Number of responses other than omission
Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Hits/Accuracy, Number of correct responses, Hits of correct responses
Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Standard deviation of the 3 standard errors calculated for each task block
Create a Normative Database for emotional, behavioral and cognitive performance
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Order of combination of responses
Create a Normative Database for emotional, behavioral and cognitive performance
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Hits of Reaction time (RT), Median of reaction times for correct responses, Hits RT SE Standard error of Hits RT, Hits RT block change
Create a Normative Database for emotional, behavioral and cognitive performance
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Slope of change in RT between blocks, Slope of change in RT standard errors between blocks
Create a Normative Database for emotional, behavioral and cognitive performance
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet SE variability Standard deviation of the 3 standard errors calculated for each task block
Create a Normative Database for emotional, behavioral and cognitive performance
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Order of combination of responses by reaction time
Create a Normative Database for emotional, behavioral and cognitive performance
Eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: Number of saccade (pro/anti-), Number of blinks
Create a Normative Database for emotional, behavioral and cognitive performance
Eye-movement for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: near-point convergence, Near-point contact point
Create a Normative Database for emotional, behavioral and cognitive performance
Eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: amplitude, direction, direction interval,
Create a Normative Database for emotional, behavioral and cognitive performance
Time of eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: reaction time, fixation, time interval
Create a Normative Database for emotional, behavioral and cognitive performance
Digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Digit-tracking associated with O-Kidia battery : direction, cumulated distance, distance to the proper trajectory
Create a Normative Database for emotional, behavioral and cognitive performance
Time of digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Digit-tracking associated with O-Kidia battery : exploration time, time to the proper trajectory
Create a Normative Database for emotional, behavioral and cognitive performance
Velocity of digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Accuracy measures are :Total errors, Number of errors in total
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - False responses, Number of responses other than omission
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Number of correct responses, Hits of correct responses
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - SE variability Standard deviation of the 3 standard errors calculated for each task block
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Order of combination of responses
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Reaction time (RT) median for correct responses, Hits RT SE Standard error of Hits RT, Hits RT block change
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Slope of change in RT between blocks, Slope of change in RT standard errors between blocks
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - SE variability Standard deviation of the 3 standard errors calculated for each task block, Order of combination of responses by reaction time
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Event planification abilities, the Tower of London Determination of performance at the test of the Tower of London coupled with eye-tracking. Tower of London: analysed variables are: Number of problems solved (maximum duration is one minute) Failure if three successive problems are unsolved Types of error : systematic rule violation, back-and-forth Percentage of problems solved with the execution (minimal) number of moves. Hits/Accuracy Number of correct responses The higher score is the better outcome.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Event planification abilities, the Tower of London Time for the performance at the test of the Tower of London coupled with eye-tracking. Duration for planification and execution Reaction Time, Total errors Hits RT Median of reaction times for correct responses, Hits RT SE Standard error of Hits RT
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the anxiety scale. The higher score is the worse outcome.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the evitant/depression scale. The higher score is the worse outcome.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the social problem scale. The higher score is the worse outcome.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Behavioral assessment of executive function scoring (BRIEF, 72 items) 72 items rated on a 3-point Likert-type scale, ranging from "never" (1) to "often" (3).The clinical scale gives a well-rounded picture of the behavior of the child or adolescent being rated.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : (Keith Conners-3, 108 items) -108-items rated on a 4-point Likert-type scale, ranging from "never" (0) to "often" (3) to give insight into ADHD assessment as well as comorbid disorders such as Oppositional Defiant Disorder and Conduct Disorder. The higher score is the worse outcome
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Autism Quotient List version scoring (10 items) -10-items rated on a 4-point Likert-type scale, ranging from "Strongly agree" (1) to "definitely disagree" (3). Only one point can be awarded for each question. Give 1 point for "Strongly agree" or "Definitely disagree " for questions 1, 5, 7, and 10. Award 1 point for "Strongly Disagree" or "Strongly Disagree" for each of questions 2, 3, 4, 6, 8 and 9. If the person scores 6 or higher, he or she probably has social difficulties requiring referral for a specialized diagnostic assessment.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : QTAC scoring, coordination acquisition disorder (15 items) 15-items rated on a 5-point Likert-type scale, ranging from "not alike" (1) to "extremyly alike disagree" (5). The higher the scores the higher coordination acquisition disorder is suspected.
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Inattention and Hyperactivity-Impulsivity components with the ADHD-Rating Scale (18 items) - Measure of number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined )
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Inattention and Hyperactivity-Impulsivity components with the ADHD-Rating Scale (18 items) - ADHD Rating Scale: 9 inattention items and 9 hyperactivity-impulsivity items rated on a 0-3 scale (range 0-27), therefore the total score is on a 0-54 range. The higher the scores the higher the inattention and hyperactivity-impulsivity
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Perseverance - the Grit-Scale for Children (GSCA, 12 items), items rated on a 1-5 scale, therefore the total score is on a 0-60 range, then divided by 12. The maximum score on this scale is 5 (extremely gritty), and the lowest scale on this scale is 1 (not at all gritty).
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Motivation - the School Motivation Questionnaire (SMQ, 10 min), 30 items on a Five-point Likert-type scale, ranging from "never" (1) to "very often" (5). The SMQ maximum total score is 150 and the minimum is 30 with solid loading scores: Self-Determination (SD), Self-Efficacy (SE), Intrinsic Motivation (IM), and Grade Motivation (GM)
Convergence validity for the O-Kidia battery
Describe the subgroup and compare it to pattern of comorbidities : Sleep quality (Pittsburgh Sleep Quality Index, 11 items) - The PSQI consists of 11 self-report questions that combine to give 7 "components" of the overall score, with each component receiving a score from 0 to 3. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The 7 components of the score are added together to give an overall score ranging from 0 to 21 points, with 0 indicating no difficulty and 21 indicating major difficulty. A global score is the addition of these 7 components.

Secondary Outcome Measures

Description of participants' characteristics
Measure of demographics with age
Description of participants' characteristics
Measure of language spoken
Description of participants' characteristics
Measure of family structure, school, medical history with questionnaires
Description of participants' characteristics
Measure of manual laterality, Edinburgh handedness, short version, to indicate manual laterality from 4 items rated on a five-point Likert-type scale, ranging from "always right" to "always left", scoring from +100 to -100.
Description of participants' characteristics
Socioeconomic status as measure INSEE index
mobile EEG biomarkers
P300 wave amplitude and latency - Quantitative electroencephalography (qEEG) will be recorded during a resting state, Elicitation of evoked potentials (ERP) will use the O-Kidia battery to elicit components associated with attention, working memory, stress, or anxiety
mobile EEG biomarkers
P1, N1, P2, N2 and P3 waves, amplitudes and latencies - Elicitation of evoked potentials (ERP) will use the O-Kidia battery to elicit components associated with attention, stress, or anxiety
mobile EEG biomarkers
N170 waves, amplitudes and latencies as measures of episodic memory
mobile EEG biomarkers
Alpha-, theta, beta waves and their ratios as a measures of ADHD assessments.
UX/UI feasibility
Questionnaire (10-items) assessing the usability (UX/UI) for children, on a five-point likert type scale ranging 0 to 50 points, higher scores meaning better outcome.
Test-retrests for the O-Games battery
Significant changes of either or both scores at T2 compared with baseline (repeated testing), higher scores meaning better outcome.

Full Information

First Posted
September 16, 2022
Last Updated
October 18, 2023
Sponsor
O-Kidia
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1. Study Identification

Unique Protocol Identification Number
NCT05577533
Brief Title
Digital Epidemiology Study on Brain Functioning
Acronym
EPIDIA4Kids
Official Title
Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
O-Kidia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Neurobiology has improved the integrative understanding of brain development. With digital technologies, digital (bio)markers would be relevant variables for a better understanding of the heterogeneity of cognitive and behavioral functioning in developing children. However, the dominant statistical approach of group comparison tends to ignore intragroup variability. Applying high-dimensional data sets through multivariate methods and then combining their scores via predictive model learning algorithms would allow the identification of subtypes. Thus, EPIDIA4KIDS wants to understand the brain functioning of children aged 7 to 12 years old from heterogeneous data sources collected from a touchscreen tablet.
Detailed Description
The overall objective of the EPIDIA4KIDS study is to understand brain functioning in children aged 7 to 12 years from heterogeneous digital data collected with a touch tablet. The investigators want to develop a digital e-screening, similarly to a blood test result, for cognitive, emotional and behavioral performances in children from 7 to 12 years old, resulting from a multimodal and multi-stream analysis generated by an artificial intelligence algorithm. The main aims are therefore to: Develop a normative base of cognitive, emotional and, behavioral performances with children aged 7 to 12 years old using our digital tool. Examine the validity of our e-assessment by comparing the generated results to those obtained with standard measures of convergent validity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development, Child Development Disorder
Keywords
Digital Epidemiology, Child, Neurodevelopment, Neurodevelopmental disorders, Mental disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
O-Kidia battery
Arm Type
Other
Arm Description
A one-time visit will be performed in children aged 7 to 12 years old as follow : Children will be playing on a series of games with a touch screen tablet while video, EEGs and digit trajectories data will be collected from this mobile device Video recording of the participants during the tablet testing via the intrinsic camera - 30 min Assessments - Paper and tablet psychometric tests will be used during the administrations, 1h45 Child health questionnaires - Questionnaires will be completed by children and parents during the visit, 20 min for each
Intervention Type
Behavioral
Intervention Name(s)
O-Kidia game battery
Intervention Description
Children will be playing on a series of games with a touch screen tablet while video and digit trajectories data will be collected from this mobile device to analyze eye-, face-, sound-recognition.
Intervention Type
Behavioral
Intervention Name(s)
O-Brain
Intervention Description
Electrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min
Primary Outcome Measure Information:
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Total errors, Number of errors in total, False responses
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet False responses
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Number of responses other than omission
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Hits/Accuracy, Number of correct responses, Hits of correct responses
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Standard deviation of the 3 standard errors calculated for each task block
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Measure number of criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet Order of combination of responses
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Hits of Reaction time (RT), Median of reaction times for correct responses, Hits RT SE Standard error of Hits RT, Hits RT block change
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Slope of change in RT between blocks, Slope of change in RT standard errors between blocks
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet SE variability Standard deviation of the 3 standard errors calculated for each task block
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of typically developing children when playing with the O-Kidia battery on a touchscreen tablet Order of combination of responses by reaction time
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: Number of saccade (pro/anti-), Number of blinks
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Eye-movement for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: near-point convergence, Near-point contact point
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: amplitude, direction, direction interval,
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time of eye-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Eye-tracking associated with O-Kidia battery: reaction time, fixation, time interval
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Digit-tracking associated with O-Kidia battery : direction, cumulated distance, distance to the proper trajectory
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Time of digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet - Digit-tracking associated with O-Kidia battery : exploration time, time to the proper trajectory
Time Frame
24 months
Title
Create a Normative Database for emotional, behavioral and cognitive performance
Description
Velocity of digit-movement criteria for motor skills, emotions, cognition and behavior, and therefore a neurodevelopmental presentation of developing children when playing with the O-Kidia battery on a touchscreen tablet
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Accuracy measures are :Total errors, Number of errors in total
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - False responses, Number of responses other than omission
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Number of correct responses, Hits of correct responses
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - SE variability Standard deviation of the 3 standard errors calculated for each task block
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Order of combination of responses
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Reaction time (RT) median for correct responses, Hits RT SE Standard error of Hits RT, Hits RT block change
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - Slope of change in RT between blocks, Slope of change in RT standard errors between blocks
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : WISC-V subtests, including Verbal concept, Fluid Reasoning scale, Working Memory measures, Processing Speed abilities - SE variability Standard deviation of the 3 standard errors calculated for each task block, Order of combination of responses by reaction time
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Event planification abilities, the Tower of London Determination of performance at the test of the Tower of London coupled with eye-tracking. Tower of London: analysed variables are: Number of problems solved (maximum duration is one minute) Failure if three successive problems are unsolved Types of error : systematic rule violation, back-and-forth Percentage of problems solved with the execution (minimal) number of moves. Hits/Accuracy Number of correct responses The higher score is the better outcome.
Time Frame
18 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Event planification abilities, the Tower of London Time for the performance at the test of the Tower of London coupled with eye-tracking. Duration for planification and execution Reaction Time, Total errors Hits RT Median of reaction times for correct responses, Hits RT SE Standard error of Hits RT
Time Frame
18 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the anxiety scale. The higher score is the worse outcome.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the evitant/depression scale. The higher score is the worse outcome.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Children Behavior Check List (short version, 32 items) 32 items rated on a 3-point Likert-type scale, ranging from "never" (0) to "very often" (3) for the social problem scale. The higher score is the worse outcome.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Behavioral assessment of executive function scoring (BRIEF, 72 items) 72 items rated on a 3-point Likert-type scale, ranging from "never" (1) to "often" (3).The clinical scale gives a well-rounded picture of the behavior of the child or adolescent being rated.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : (Keith Conners-3, 108 items) -108-items rated on a 4-point Likert-type scale, ranging from "never" (0) to "often" (3) to give insight into ADHD assessment as well as comorbid disorders such as Oppositional Defiant Disorder and Conduct Disorder. The higher score is the worse outcome
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Autism Quotient List version scoring (10 items) -10-items rated on a 4-point Likert-type scale, ranging from "Strongly agree" (1) to "definitely disagree" (3). Only one point can be awarded for each question. Give 1 point for "Strongly agree" or "Definitely disagree " for questions 1, 5, 7, and 10. Award 1 point for "Strongly Disagree" or "Strongly Disagree" for each of questions 2, 3, 4, 6, 8 and 9. If the person scores 6 or higher, he or she probably has social difficulties requiring referral for a specialized diagnostic assessment.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : QTAC scoring, coordination acquisition disorder (15 items) 15-items rated on a 5-point Likert-type scale, ranging from "not alike" (1) to "extremyly alike disagree" (5). The higher the scores the higher coordination acquisition disorder is suspected.
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Inattention and Hyperactivity-Impulsivity components with the ADHD-Rating Scale (18 items) - Measure of number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined )
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Inattention and Hyperactivity-Impulsivity components with the ADHD-Rating Scale (18 items) - ADHD Rating Scale: 9 inattention items and 9 hyperactivity-impulsivity items rated on a 0-3 scale (range 0-27), therefore the total score is on a 0-54 range. The higher the scores the higher the inattention and hyperactivity-impulsivity
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Perseverance - the Grit-Scale for Children (GSCA, 12 items), items rated on a 1-5 scale, therefore the total score is on a 0-60 range, then divided by 12. The maximum score on this scale is 5 (extremely gritty), and the lowest scale on this scale is 1 (not at all gritty).
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Motivation - the School Motivation Questionnaire (SMQ, 10 min), 30 items on a Five-point Likert-type scale, ranging from "never" (1) to "very often" (5). The SMQ maximum total score is 150 and the minimum is 30 with solid loading scores: Self-Determination (SD), Self-Efficacy (SE), Intrinsic Motivation (IM), and Grade Motivation (GM)
Time Frame
24 months
Title
Convergence validity for the O-Kidia battery
Description
Describe the subgroup and compare it to pattern of comorbidities : Sleep quality (Pittsburgh Sleep Quality Index, 11 items) - The PSQI consists of 11 self-report questions that combine to give 7 "components" of the overall score, with each component receiving a score from 0 to 3. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The 7 components of the score are added together to give an overall score ranging from 0 to 21 points, with 0 indicating no difficulty and 21 indicating major difficulty. A global score is the addition of these 7 components.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Description of participants' characteristics
Description
Measure of demographics with age
Time Frame
24 months
Title
Description of participants' characteristics
Description
Measure of language spoken
Time Frame
24 months
Title
Description of participants' characteristics
Description
Measure of family structure, school, medical history with questionnaires
Time Frame
24 months
Title
Description of participants' characteristics
Description
Measure of manual laterality, Edinburgh handedness, short version, to indicate manual laterality from 4 items rated on a five-point Likert-type scale, ranging from "always right" to "always left", scoring from +100 to -100.
Time Frame
24 months
Title
Description of participants' characteristics
Description
Socioeconomic status as measure INSEE index
Time Frame
24 months
Title
mobile EEG biomarkers
Description
P300 wave amplitude and latency - Quantitative electroencephalography (qEEG) will be recorded during a resting state, Elicitation of evoked potentials (ERP) will use the O-Kidia battery to elicit components associated with attention, working memory, stress, or anxiety
Time Frame
24 months
Title
mobile EEG biomarkers
Description
P1, N1, P2, N2 and P3 waves, amplitudes and latencies - Elicitation of evoked potentials (ERP) will use the O-Kidia battery to elicit components associated with attention, stress, or anxiety
Time Frame
24 months
Title
mobile EEG biomarkers
Description
N170 waves, amplitudes and latencies as measures of episodic memory
Time Frame
24 months
Title
mobile EEG biomarkers
Description
Alpha-, theta, beta waves and their ratios as a measures of ADHD assessments.
Time Frame
24 months
Title
UX/UI feasibility
Description
Questionnaire (10-items) assessing the usability (UX/UI) for children, on a five-point likert type scale ranging 0 to 50 points, higher scores meaning better outcome.
Time Frame
12 months
Title
Test-retrests for the O-Games battery
Description
Significant changes of either or both scores at T2 compared with baseline (repeated testing), higher scores meaning better outcome.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Boys or girls Aged 7 to 12 years Fluent in the French language Agreement and signature of informed consent by the child Agreement and signature of informed consent by one of the legal representatives Estimated intelligence quotient > 85 Exclusion Criteria: No biological parent or legal guardian is able to give permission for the minor and agrees to participate in parental assessments Prematurity or other perinatal complications that required significant intervention History of neurological disorders, including seizure disorders, cerebral palsy, or other conditions requiring neurological or medical care : History of head injury: Head trauma more than one year old with loss of consciousness >30 minutes, OR Had to be hospitalized for head trauma, OR Amnesia > 24 hours, OR Confusion or loss of orientation >24 hours, OR A brain scan revealed problems following a head injury, OR Head trauma within the past year with loss of consciousness >10 minutes. Current or persistent major Axis I psychiatric disorder that may interfere with successful completion of the protocol (e.g., psychosis and bipolar disorder), or substance use disorder. Current use of medications with significant effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); Attention Deficit Hyperactivity Disorder (ADHD) medications and Selective Serotonin Reuptake Inhibitors (SSRIs) are not excluded as the use of these medications is associated with certain neurodevelopmental disorders and assessment of these individuals will provide useful data to the community Not fluent in French (all youth materials are in French) Uncorrectable visual, hearing, or sensorimotor impairment, as the protocol items may not be valid.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Douet Vannucci, PhD
Phone
+33768717649
Email
vanessa.douet@o-kidia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Théo Marchand, Msc
Phone
+33622236076
Email
theo.marchand@o-kidia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Douet Vannucci, PhD
Organizational Affiliation
O-Kidia
Official's Role
Principal Investigator
Facility Information:
Facility Name
O-Kidia
City
Gardanne
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
13120
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Douet Vannucci, PhD
Phone
+33768717649
Email
vanessa.douet@o-kidia.com
First Name & Middle Initial & Last Name & Degree
Theo Marchand, Msc
Phone
+33633236076
First Name & Middle Initial & Last Name & Degree
Vanessa Douet Vannucci, PhD
Facility Name
Association la Busserine
City
Marseille
State/Province
Provence Alpes Cotes d'Azur
ZIP/Postal Code
13014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theo Marchand, MsC
Email
theo.marchand@o-kidia.com
First Name & Middle Initial & Last Name & Degree
Vanessa Douet Vannucci, PhD

12. IPD Sharing Statement

Links:
URL
https://www.o-kidia.com
Description
O-Kida website

Learn more about this trial

Digital Epidemiology Study on Brain Functioning

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