NCT05577533

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
736

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

September 16, 2022

Last Update Submit

October 18, 2023

Conditions

Child DevelopmentChild Development Disorder

Keywords

Digital EpidemiologyChildNeurodevelopmentNeurodevelopmental disordersMental disorders

Outcome Measures

Primary Outcomes (39)

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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,

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

    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

    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.

    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.

    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.

    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.

    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

    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.

    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.

    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 )

    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

    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).

    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)

    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.

    24 months

Secondary Outcomes (11)

  • Description of participants' characteristics

    24 months

  • Description of participants' characteristics

    24 months

  • Description of participants' characteristics

    24 months

  • Description of participants' characteristics

    24 months

  • Description of participants' characteristics

    24 months

  • +6 more secondary outcomes

Study Arms (1)

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

Behavioral: O-Kidia game batteryBehavioral: O-Brain

Interventions

O-Kidia game batteryBEHAVIORAL

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-Kidia battery
O-BrainBEHAVIORAL

Electrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min

O-Kidia battery

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Association la Busserine

Marseille, Provence Alpes Cotes d'Azur, 13014, France

NOT YET RECRUITING

O-Kidia

Gardanne, Provence-Alpes-CĂ´te d'Azur Region, 13120, France

RECRUITING

Related Links

MeSH Terms

Conditions

Developmental DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Vanessa Douet Vannucci, PhD

    O-Kidia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Douet Vannucci, PhD

CONTACT

+33768717649vanessa.douet@o-kidia.com

Théo Marchand, Msc

CONTACT

+33622236076theo.marchand@o-kidia.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

October 13, 2022

Study Start

March 21, 2023

Primary Completion

July 1, 2024

Study Completion

September 30, 2024

Last Updated

October 19, 2023

Record last verified: 2023-04

Locations

FR(2)