NCT05780853 A Game-based Neurodevelopmental Assessment for Young Children
| NCT ID | NCT05780853 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brightlobe Limited |
| Condition | Neurodevelopmental Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 590 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2026-06-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 3 to 8 year old 'typically' developing children with no known neurodevelopmental disorder. OR * 3 to 8 year old children with a diagnosed neurodevelopmental disorder, including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder. 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: * Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.