Digital Epidemiology Study on Brain Functioning
- Conditions
- Child Development DisorderChild Development
- Interventions
- Behavioral: O-Kidia game batteryBehavioral: O-Brain
- Registration Number
- NCT05577533
- Lead Sponsor
- O-Kidia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 736
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description O-Kidia battery O-Kidia game battery 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 O-Kidia battery O-Brain 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
- Primary Outcome Measures
Name Time Method Convergence validity for the O-Kidia battery 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.Create a Normative Database for emotional, behavioral and cognitive performance 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
- Secondary Outcome Measures
Name Time Method mobile EEG biomarkers 24 months Alpha-, theta, beta waves and their ratios as a measures of ADHD assessments.
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.
Description of participants' characteristics 24 months Socioeconomic status as measure INSEE index
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.
Trial Locations
- Locations (2)
O-Kidia
🇫🇷Gardanne, Provence Alpes Cote d'Azur, France
Association la Busserine
🇫🇷Marseille, Provence Alpes Cotes d'Azur, France