Child DevelopmentEPIDIA4KidsNCT05577533
Digital Epidemiology Study on Brain Functioning
A study testing O-Kidia game battery and O-Brain in people with Child Development and Child Development Disorder, run by O-Kidia at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Development Disorder
- What is being tested?
- O-Kidia game battery and O-Brain
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 736 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Mar 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
O-Kidia
Gardanne, Provence-Alpes-Côte d'Azur Region, 13120
Vanessa Douet Vannucci, PhD, +33768717649, vanessa.douet@o-kidia.com
Theo Marchand, Msc, +33633236076
- Not yet recruiting
Association la Busserine
Marseille, Provence Alpes Cotes d'Azur, 13014
Theo Marchand, MsC, theo.marchand@o-kidia.com
Vanessa Douet Vannucci, PhD
About this study
Official title: Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years
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.
Read the 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.
- Conditions
- Child Development, Child Development Disorder
- Being tested
- O-Kidia game battery, O-Brain
- Keywords
- Digital Epidemiology, Child, Neurodevelopment, Neurodevelopmental disorders, Mental disorders
- Medical subject headings
- Developmental Disabilities, Neurodevelopmental Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-Kidia game batteryBehavioural
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.
O-BrainBehavioural
Electrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min
| Study group | Role | What they receive |
|---|---|---|
| O-Kidia battery | Other | 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
1. Video recording of the participants during the tablet testing via the intrinsic camera - 30 min
2. Assessments - Paper and tablet psychometric tests will be used during the administrations, 1h45
3. Child health questionnaires - Questionnaires will be completed by children and parents during the visit, 20 min for each Receives: Behavioral: O-Kidia game battery; Behavioral: O-Brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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,
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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.
Measured: 18 months
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
Measured: 18 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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 )
Measured: 24 months
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
Measured: 24 months
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).
Measured: 24 months
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)
Measured: 24 months
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.
Measured: 24 months
Secondary outcomes (11)
Description of participants' characteristics
Measure of demographics with age
Measured: 24 months
Description of participants' characteristics
Measure of language spoken
Measured: 24 months
Description of participants' characteristics
Measure of family structure, school, medical history with questionnaires
Measured: 24 months
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.
Measured: 24 months
Description of participants' characteristics
Socioeconomic status as measure INSEE index
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
mobile EEG biomarkers
N170 waves, amplitudes and latencies as measures of episodic memory
Measured: 24 months
mobile EEG biomarkers
Alpha-, theta, beta waves and their ratios as a measures of ADHD assessments.
Measured: 24 months
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.
Measured: 12 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start21 Mar 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- O-Kidia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanessa Douet Vannucci, PhD, Principal investigator, O-Kidia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577533
- Sponsor's protocol ID
- 2022-A00766-37
- Other IDs
- 2022-002949-17
- Acronym
- EPIDIA4Kids
- Status last verified
- Apr 2023
- First submitted
- 16 Sep 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years
- ClinicalTrials.gov ID
- NCT05577533
- Acronym / sponsor ID
- EPIDIA4Kids / 2022-A00766-37
- Conditions
- Child Development, Child Development Disorder
- Keywords
- Digital Epidemiology, Child, Neurodevelopment, Neurodevelopmental disorders, Mental disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 736 participants (estimated)
- Lead sponsor
- O-KidiaIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| O-Kidia battery | Other | Behavioral: O-Kidia game battery, Behavioral: O-BrainA 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 1. Video recording of the participants during the tablet testing via the intrinsic camera - 30 min 2. Assessments - Paper and tablet psychometric tests will be used during the administrations, 1h45 3. Child health questionnaires - Questionnaires will be completed by children and parents during the visit, 20 min for each |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O-Kidia game batteryChildren 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. | Behavioural | O-Kidia battery |
| O-BrainElectrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min | Behavioural | O-Kidia battery |
Primary outcome
Create a Normative Database for emotional, behavioral and cognitive performance
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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 frame: 24 months
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 frame: 24 months
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 frame: 24 months
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 frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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 frame: 24 months
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
Time frame: 24 months
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 frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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.
11 secondary outcomes
Description of participants' characteristics
Time frame: 24 months
Description of participants' characteristics
Time frame: 24 months
Description of participants' characteristics
Time frame: 24 months
Description of participants' characteristics
Time frame: 24 months
Description of participants' characteristics
Time frame: 24 months
mobile EEG biomarkers
Time frame: 24 months
mobile EEG biomarkers
Time frame: 24 months
mobile EEG biomarkers
Time frame: 24 months
mobile EEG biomarkers
Time frame: 24 months
UX/UI feasibility
Time frame: 12 months
Test-retrests for the O-Games battery
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- O-Kida websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Douet Vannucci, PhD principal investigator
O-Kidia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O-Kidia game battery and O-Brain in people with Child Development and Child Development Disorder, run by O-Kidia at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Douet Vannucci, PhD (+33768717649, vanessa.douet@o-kidia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a Normative Database for emotional, behavioral and cognitive performance (time frame: 24 months). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.