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Digital Epidemiology Study on Brain Functioning (EPIDIA4Kids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05577533
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : April 14, 2023
Sponsor:
Information provided by (Responsible Party):
O-Kidia

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Child Development Child Development Disorder Behavioral: O-Kidia game battery Behavioral: O-Brain Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 736 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years
Actual Study Start Date : March 21, 2023
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : September 30, 2024
Arms and Interventions
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Arm Intervention/treatment
O-Kidia 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
 Behavioral: O-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.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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


  5. 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


  6. 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


  7. 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


  8. 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


  9. 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


  10. 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


  11. 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


  12. 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


  13. 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,


  14. 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


  15. 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


  16. 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


  17. 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

  18. 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


  19. 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


  20. 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


  21. 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


  22. 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


  23. 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


  24. 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


  25. 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


  26. 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.


  27. 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

  28. 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.

  29. 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.

  30. 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.

  31. 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.


  32. 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


  33. 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.


  34. 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.


  35. 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 )


  36. 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


  37. 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).


  38. 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)


  39. 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.



Secondary Outcome Measures :
  1. Description of participants' characteristics [ Time Frame: 24 months ]
    Measure of demographics with age

  2. Description of participants' characteristics [ Time Frame: 24 months ]
    Measure of language spoken

  3. Description of participants' characteristics [ Time Frame: 24 months ]
    Measure of family structure, school, medical history with questionnaires

  4. Description of participants' characteristics [ Time Frame: 24 months ]
    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.

  5. Description of participants' characteristics [ Time Frame: 24 months ]
    Socioeconomic status as measure INSEE index

  6. mobile EEG biomarkers [ Time Frame: 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

  7. mobile EEG biomarkers [ Time Frame: 24 months ]
    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

  8. mobile EEG biomarkers [ Time Frame: 24 months ]
    N170 waves, amplitudes and latencies as measures of episodic memory

  9. mobile EEG biomarkers [ Time Frame: 24 months ]
    Alpha-, theta, beta waves and their ratios as a measures of ADHD assessments.

  10. UX/UI feasibility [ Time Frame: 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.

  11. Test-retrests for the O-Games battery [ Time Frame: 24 months ]
    Significant changes of either or both scores at T2 compared with baseline (repeated testing), higher scores meaning better outcome.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05577533


Contacts
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Contact: Vanessa Douet Vannucci, PhD +33768717649 vanessa.douet@o-kidia.com
Contact: Théo Marchand, Msc +33622236076 theo.marchand@o-kidia.com

Locations
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France
O-Kidia Recruiting
Gardanne, Provence Alpes Cote d'Azur, France, 13120
Contact: Vanessa Douet Vannucci, PhD    +33768717649    vanessa.douet@o-kidia.com   
Contact: Theo Marchand, Msc    +33633236076      
Principal Investigator: Vanessa Douet Vannucci, PhD         
Association la Busserine Not yet recruiting
Marseille, Provence Alpes Cotes d'Azur, France, 13014
Contact: Theo Marchand, MsC       theo.marchand@o-kidia.com   
Principal Investigator: Vanessa Douet Vannucci, PhD         
Sponsors and Collaborators
O-Kidia
Investigators
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Principal Investigator: Vanessa Douet Vannucci, PhD O-Kidia
More Information
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Additional Information:

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Responsible Party: O-Kidia
ClinicalTrials.gov Identifier: NCT05577533    
Other Study ID Numbers: 2022-A00766-37
2022-002949-17 ( EudraCT Number )
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by O-Kidia:
Digital Epidemiology
Child
Neurodevelopment
Neurodevelopmental disorders
Mental disorders
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders