A Game-based Neurodevelopmental Assessment for Young Children

NCT ID: NCT05780853

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Neurodevelopmental Disorders Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Dyslexia Specific Learning Disorder Child Development

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Typically Developing Children (Control Group)

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.

Tablet Game-based Assessment - YARN assessment service

Intervention Type DIAGNOSTIC_TEST

Tablet game-based assessment to assess neurodevelopmental profile.

Adaptive Behavior Assessment System, Third Edition (ABAS-3)

Intervention Type DIAGNOSTIC_TEST

A parent-reported child behavioural assessment questionnaire used to diagnose and classify various developmental, learning and behavioural disabilities and disorders.

Demographic questionnaire

Intervention Type OTHER

Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.

Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group)

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.

Tablet Game-based Assessment - YARN assessment service

Intervention Type DIAGNOSTIC_TEST

Tablet game-based assessment to assess neurodevelopmental profile.

Adaptive Behavior Assessment System, Third Edition (ABAS-3)

Intervention Type DIAGNOSTIC_TEST

A parent-reported child behavioural assessment questionnaire used to diagnose and classify various developmental, learning and behavioural disabilities and disorders.

Demographic questionnaire

Intervention Type OTHER

Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.

Interventions

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Tablet Game-based Assessment - YARN assessment service

Tablet game-based assessment to assess neurodevelopmental profile.

Intervention Type DIAGNOSTIC_TEST

Adaptive Behavior Assessment System, Third Edition (ABAS-3)

A parent-reported child behavioural assessment questionnaire used to diagnose and classify various developmental, learning and behavioural disabilities and disorders.

Intervention Type DIAGNOSTIC_TEST

Demographic questionnaire

Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brightlobe Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Iles, PhD DClinPsy

Role: PRINCIPAL_INVESTIGATOR

Brightlobe Limited

Locations

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Brightlobe Limited

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Shivani Lamba

Role: CONTACT

+447872989457

Facility Contacts

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Shivani Lamba

Role: primary

Other Identifiers

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BRIGHTEN-01

Identifier Type: -

Identifier Source: org_study_id

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