A Game-based Neurodevelopmental Assessment for Young Children (BRIGHTEN)

Brightlobe

Status: Enrolling

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

Treatments: Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Diagnostic Test: Tablet Game-based Assessment - YARN assessment service; Other: Demographic questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT05780853

BRIGHTEN-01

Details and patient eligibility

About

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.

Enrollment: 590 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

590 participants in 2 patient groups

Typically Developing Children (Control Group)

Description:

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.

Treatment:

Other: Demographic questionnaire

Diagnostic Test: Tablet Game-based Assessment - YARN assessment service

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

Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group)

Description:

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.

Treatment:

Other: Demographic questionnaire

Diagnostic Test: Tablet Game-based Assessment - YARN assessment service

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