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NCT Number: NCT05780853

A 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.

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Key information

Conditions

Neurodevelopmental Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Child Development Child Development Disorders, Pervasive Communication Disorders Dyslexia Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brightlobe Limited

London, United Kingdom

Location status: Recruiting

Location contact

Shivani Lamba

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tablet Game-based Assessment - YARN assessment service

Diagnostic Test

Tablet game-based assessment to assess neurodevelopmental profile.

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

Diagnostic Test

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

Demographic Questionnaire

Other

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

Primary outcomes

  1. Diagnostic accuracy of the tablet game-based assessment

    Time frame: 16 months

    Sensitivity and specificity of the tablet game-based assessment to accurately differentiate children's neurodevelopmental status.

  2. Construct validity of the tablet game-based assessment

    Time frame: 16 months

    Using exploratory factor analysis to explore the construct validity of the tablet game-based assessment.

  3. Internal consistency of the tablet game-based assessment

    Time frame: 16 months

    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.

  4. Known-group and predictive validity of the tablet game-based assessment

    Time frame: 16 months

    Known-group and predictive validity will both be assessed through multiple logistic regression.

Secondary outcomes

  1. Preliminary normative data for performance on the tablet game-based assessment tool

    Time frame: 16 months

    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.

  2. Acceptability of the tablet game-based assessment tool and device

    Time frame: 16 months

    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?).

  3. Re-test reliability of the tablet game-based assessment tool

    Time frame: 16 months

    Acceptable levels of test-retest reliability/stability using Intraclass Correlation Coefficient (ICC) at two different time points within 2 weeks.

  4. Safety of the tablet game-based assessment tool and device

    Time frame: 16 months

    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.

Other outcomes

  1. Participant demographics

    Time frame: 16 months

    Descriptive analyses of participant demographics (e.g., age, ethnicity, employment status, household income, medical history and education status)

  2. Scores on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)

    Time frame: 16 months

    Scores on the parent-reported questionnaire (ABAS-3)

Study contacts

Contact information is provided by the study sponsor or research team.

Shivani Lamba

CONTACT

[email protected]

+447872989457

Sponsors and collaborators

Lead sponsor

Brightlobe Limited

Industry

Registry information

Official study title

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

Acronym: BRIGHTEN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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