A Game-based Neurodevelopmental Assessment for Young Children
- Conditions
- Neurodevelopmental DisordersAutism Spectrum DisorderAttention Deficit Hyperactivity DisorderChild DevelopmentDyslexiaSpecific Learning Disorder
- Interventions
- Diagnostic Test: Tablet Game-based Assessment - YARN assessment serviceDiagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3)Other: Demographic questionnaire
- Registration Number
- NCT05780853
- Lead Sponsor
- Brightlobe Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 590
- 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.
- Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Typically Developing Children (Control Group) Demographic questionnaire 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. Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group) Adaptive Behavior Assessment System, Third Edition (ABAS-3) 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. Typically Developing Children (Control Group) Tablet Game-based Assessment - YARN assessment service 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. Typically Developing Children (Control Group) Adaptive Behavior Assessment System, Third Edition (ABAS-3) 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. Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group) Tablet Game-based Assessment - YARN assessment service 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. Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group) 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.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of the tablet game-based assessment 16 months Sensitivity and specificity of the tablet game-based assessment to accurately differentiate children's neurodevelopmental status.
Construct validity of the tablet game-based assessment 16 months Using exploratory factor analysis to explore the construct validity of the tablet game-based assessment.
Internal consistency of the tablet game-based assessment 16 months 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.
Known-group and predictive validity of the tablet game-based assessment 16 months Known-group and predictive validity will both be assessed through multiple logistic regression.
- Secondary Outcome Measures
Name Time Method Preliminary normative data for performance on the tablet game-based assessment tool 16 months 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.
Acceptability of the tablet game-based assessment tool and device 16 months 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?).
Re-test reliability of the tablet game-based assessment tool 16 months Acceptable levels of test-retest reliability/stability using Intraclass Correlation Coefficient (ICC) at two different time points within 2 weeks.
Safety of the tablet game-based assessment tool and device 16 months 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.
Trial Locations
- Locations (1)
Brightlobe Limited
🇬🇧London, United Kingdom