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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 590 participants in total. It began in 2023-01-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jane Iles, PhD DClinPsy
PRINCIPAL INVESTIGATOR
Brightlobe Limited
Frequently Asked Questions
Who can join the NCT05780853 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05780853 currently recruiting?
Yes, NCT05780853 is actively recruiting participants. Contact the research team at study@brightlobe.com for enrollment information.
Where is the NCT05780853 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05780853 clinical trial?
NCT05780853 is sponsored by Brightlobe Limited. The principal investigator is Jane Iles, PhD DClinPsy at Brightlobe Limited. The trial plans to enroll 590 participants.