Evaluation of a Novel Game-based Neurodevelopmental Assessment for Young Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the tablet game-based assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3 to 8 year old 'typically' developing children with no known neurodevelopmental disorder.
- •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.
排除标准
- •Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
结局指标
主要结局
Diagnostic accuracy of the tablet game-based assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 16 months
Known-group and predictive validity will both be assessed through multiple logistic regression.
次要结局
- Preliminary normative data for performance on the tablet game-based assessment tool(16 months)
- Acceptability of the tablet game-based assessment tool and device(16 months)
- Re-test reliability of the tablet game-based assessment tool(16 months)
- Safety of the tablet game-based assessment tool and device(16 months)