Child Development, Child Development Disorder
Conditions
Keywords
Digital Epidemiology, Child, Neurodevelopment, Neurodevelopmental disorders, Mental disorders
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.
Interventions
BEHAVIORALO-Kidia game battery
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.
BEHAVIORALO-Brain
Electrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min
Sponsors
O-Kidia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Create a Normative Database for emotional, behavioral and cognitive performance | 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 |
| Convergence validity for the O-Kidia battery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of participants' characteristics | 24 months | Measure of demographics with age |
| mobile EEG biomarkers | 24 months | 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 |
| UX/UI feasibility | 12 months | 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 | 24 months | Significant changes of either or both scores at T2 compared with baseline (repeated testing), higher scores meaning better outcome. |
Countries
France
Contacts
Primary ContactVanessa Douet Vannucci, PhD
Backup ContactThéo Marchand, Msc
Outcome results
None listed