A Game-based Neurodevelopmental Assessment for Young Children

Autism Spectrum Disorder Clinical Trial

— BRIGHTEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780853
• Other study ID #: BRIGHTEN-01
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Brightlobe Limited
• Contact: Teresa Tang, PhD
• Phone: +447475758012
• Email: teresa[@]brightlobe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: June 30, 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Tablet Game-based Assessment - YARN assessment service
Tablet game-based assessment to assess neurodevelopmental profile.
• 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.

Locations

Country	Name	City	State
United Kingdom	Brightlobe Limited	London

Sponsors (1)

Lead Sponsor	Collaborator
Brightlobe Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

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