Clinical trial NCT05780853: A Game-based Neurodevelopmental Assessment for Young Children
Official title: Evaluation of a Novel Game-based Neurodevelopmental Assessment for Young Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodevelopmental Disorders
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Dyslexia
Specific Learning Disorder
Child Development
Keywords: Diagnostic test
Neurodevelopment
Medical technology
Lead sponsor: Brightlobe Limited
Sponsor class: INDUSTRY
First posted: 2023-03-23
Enrollment: 590
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Primary outcomes:
measure: Diagnostic accuracy of the tablet game-based assessment
timeFrame: 16 months
measure: Construct validity of the tablet game-based assessment
timeFrame: 16 months
measure: Internal consistency of the tablet game-based assessment
timeFrame: 16 months
measure: Known-group and predictive validity of the tablet game-based assessment
timeFrame: 16 months
Secondary outcomes:
measure: Preliminary normative data for performance on the tablet game-based assessment tool
timeFrame: 16 months
measure: Acceptability of the tablet game-based assessment tool and device
timeFrame: 16 months
measure: Re-test reliability of the tablet game-based assessment tool
timeFrame: 16 months
measure: Safety of the tablet game-based assessment tool and device
timeFrame: 16 months
Other outcomes:
measure: Participant demographics
timeFrame: 16 months
measure: Scores on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
timeFrame: 16 months
Locations:
city: London
country: United Kingdom
facility: Brightlobe Limited
Study officials:
affiliation: Brightlobe Limited
name: Jane Iles, PhD DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: