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

Evaluation of a Novel Game-based Neurodevelopmental Assessment for Young Children

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Dyslexia; Child Development; Specific Learning Disorder
• Intervention / Treatment: Diagnostic test: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Other: Demographic questionnaire; Diagnostic test: Tablet Game-based Assessment - YARN assessment service

• Study Type: Observational
• Enrollment (Estimated): 590

Contacts and Locations

• Study Contact: Name: Teresa Tang, PhD; Phone Number: +447475758012; Email: teresa@brightlobe.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Brightlobe Limited
    • Contact: Teresa Tang, PhD; Email: teresa@brightlobe.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other: Demographic questionnaire; Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.; Diagnostic test: Tablet Game-based Assessment - YARN assessment service; Tablet game-based assessment to assess neurodevelopmental profile.
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.	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.; Other: Demographic questionnaire; Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.; Diagnostic test: Tablet Game-based Assessment - YARN assessment service; Tablet game-based assessment to assess neurodevelopmental profile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of the tablet game-based assessment	Sensitivity and specificity of the tablet game-based assessment to accurately differentiate children's neurodevelopmental status.	16 months
Construct validity of the tablet game-based assessment	Using exploratory factor analysis to explore the construct validity of the tablet game-based assessment.	16 months
Internal consistency of the tablet game-based assessment	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.	16 months
Known-group and predictive validity of the tablet game-based assessment	Known-group and predictive validity will both be assessed through multiple logistic regression.	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary normative data for performance on the tablet game-based assessment tool	Performance on the tablet game-based assessment tool will be obtained from metadata and psychometric data obtained from the game-based assessment tool and device such as response time, correct/incorrect responses and gyroscope readings. Performance scores may be dichotomous, continuous and/or counts. Preliminary normative data for performance on the tablet game-based assessment tool will be defined through an exploratory factor analysis.	16 months
Acceptability of the tablet game-based assessment tool and device	Parent and child acceptability of the tablet-game based assessment tool and device will be conducted by asking parents 3 brief questions to assess parental perception of acceptability (e.g. Having seen your child complete the game today, how do you think they found the experience?). Child acceptability will be accessed using a smileyometer scale (5 ratings) to rate how they felt about the game-based assessment. Children will also be asked 8 brief questions about their opinions on the game (e.g. What did you think about the game?).	16 months
Re-test reliability of the tablet game-based assessment tool	Acceptable levels of test-retest reliability/stability using Intraclass Correlation Coefficient (ICC) at two different time points within 2 weeks.	16 months
Safety of the tablet game-based assessment tool and device	Any adverse events occurring during the duration of the study will be recorded and reported at the end of the study. These will be recorded as the number of events with qualitative data about the nature of the event. These events will then be grouped into different types of risk, and how likely they would be to occur in any future use of the device.	16 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant demographics	Descriptive analyses of participant demographics (e.g., age, ethnicity, employment status, household income, medical history and education status)	16 momths
Scores on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)	Scores on the parent-reported questionnaire (ABAS-3)	16 months

Collaborators and Investigators

• Sponsor: Brightlobe Limited
• Investigators: Principal Investigator: Jane Iles, PhD DClinPsy, Brightlobe Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Diagnostic test; Neurodevelopment; Medical technology
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Attention Deficit and Disruptive Behavior Disorders; Child Development Disorders, Pervasive; Language Disorders; Communication Disorders; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Dyslexia; Neurodevelopmental Disorders; Learning Disabilities; Specific Learning Disorder
• Other Study ID Numbers: BRIGHTEN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No