An observational study in Neurodevelopmental Disorders, Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, sponsored by Brightlobe Limited. Recruiting at 1 site in United Kingdom. Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Brightlobe Limited · Observational
The aim of this study is to evaluate a novel tablet game-based neurodevelopmental assessment tool for young children aged 3 to 8 years old.
The study's main aims are: (1) to determine whether the novel tablet-game based assessment tool can accurately differentiate children's neurodevelopmental status based on their performance on the game and (2) assess the validity of the game-based neurodevelopment assessment tool.
The study aims to recruit 590 children who are 'typically' developing and/or have a diagnosed neurodevelopmental disorder including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder.
All participants will complete the tablet game-based assessment which aims to assess a range of neuropsychological functions including attention, memory, language, motor, executive functions and social-emotional skills. Parents/carers of participants will also complete a demographic questionnaire and the Adaptive Behaviour System - Third Edition (ABAS-3), which is a questionnaire that assesses a child's development. Some participants will be re-tested on the tablet game-based assessment approximately 2 weeks after the first tablet game-based assessment to ensure the game's validity.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 590 is above the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →This is the only study on the registry with Brightlobe Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Children will be recruited into the study from nurseries, preschools, infant and primary schools across the United Kingdom. The study will also be shared across local libraries, playgroups, online parenting forums and groups, and parent-specific publications to make parents aware of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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All parents/caregivers and children must have a minimum level of English fluency required to complete the parent questionnaire and the game-based assessment.
Exclusion Criteria:
Typically developing children with no known neurodevelopmental disorder, medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Diagnostic Test: Tablet Game-based Assessment - YARN assessment service · Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3) · Other: Demographic questionnaire
Children with a diagnosed neurodevelopmental disorder including: Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder. Children must also have no known medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Diagnostic Test: Tablet Game-based Assessment - YARN assessment service · Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3) · Other: Demographic questionnaire
Tablet game-based assessment to assess neurodevelopmental profile.
A parent-reported child behavioural assessment questionnaire used to diagnose and classify various developmental, learning and behavioural disabilities and disorders.
Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.
Diagnostic accuracy of the tablet game-based assessment
Sensitivity and specificity of the tablet game-based assessment to accurately differentiate children's neurodevelopmental status.
Time frame: 16 months
Construct validity of the tablet game-based assessment
Using exploratory factor analysis to explore the construct validity of the tablet game-based assessment.
Time frame: 16 months
Internal consistency of the tablet game-based assessment
Cronbach's alpha and omega statistic to assess internal consistency/reliability of the tool, which assesses the extent to which all the items in the game-based assessment measure the same concept or construct.
Time frame: 16 months
Known-group and predictive validity of the tablet game-based assessment
Known-group and predictive validity will both be assessed through multiple logistic regression.
Time frame: 16 months
Preliminary normative data for performance on the tablet game-based assessment tool
Performance on the tablet game-based assessment tool will be obtained from metadata and psychometric data obtained from the game-based assessment tool and device such as response time, correct/incorrect responses and gyroscope readings. Performance scores may be dichotomous, continuous and/or counts. Preliminary normative data for performance on the tablet game-based assessment tool will be defined through an exploratory factor analysis.
Time frame: 16 months
Acceptability of the tablet game-based assessment tool and device
Parent and child acceptability of the tablet-game based assessment tool and device will be conducted by asking parents 3 brief questions to assess parental perception of acceptability (e.g. Having seen your child complete the game today, how do you think they found the experience?). Child acceptability will be accessed using a smileyometer scale (5 ratings) to rate how they felt about the game-based assessment. Children will also be asked 8 brief questions about their opinions on the game (e.g. What did you think about the game?).
Time frame: 16 months
Re-test reliability of the tablet game-based assessment tool
Acceptable levels of test-retest reliability/stability using Intraclass Correlation Coefficient (ICC) at two different time points within 2 weeks.
Time frame: 16 months
Safety of the tablet game-based assessment tool and device
Any adverse events occurring during the duration of the study will be recorded and reported at the end of the study. These will be recorded as the number of events with qualitative data about the nature of the event. These events will then be grouped into different types of risk, and how likely they would be to occur in any future use of the device.
Time frame: 16 months
Participant demographics
Descriptive analyses of participant demographics (e.g., age, ethnicity, employment status, household income, medical history and education status)
Time frame: 16 months
Scores on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Scores on the parent-reported questionnaire (ABAS-3)
Time frame: 16 months
Started Jan 2023 (actual). Primary completion is estimated for Jun 2026, 41 months after the start.
Of 70 observational studies under Neurodevelopmental Disorders, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 41 months is below that.
How these figures are worked out, and which studies are left out of them.
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Neurodevelopmental Disorders →