A Game-based Neurodevelopmental Assessment for Young Children

NCT05780853 | Recruiting

• 1 other identifier: BRIGHTEN-01
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Diagnostic test; Neurodevelopment; Medical technology

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

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

  16 months

• Acceptability of the tablet game-based assessment tool and device

  16 months

• Re-test reliability of the tablet game-based assessment tool

  16 months

• Safety of the tablet game-based assessment tool and device

  16 months

Other Outcomes (2)

• Participant demographics

  16 months

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

  16 months

Study Arms (2)

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

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

Interventions

Tablet Game-based Assessment - YARN assessment service DIAGNOSTIC_TEST

Tablet game-based assessment to assess neurodevelopmental profile.

Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group); Typically Developing Children (Control Group)

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.

Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group); Typically Developing Children (Control Group)

Demographic questionnaire 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); Typically Developing Children (Control Group)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• to 8 year old 'typically' developing children with no known neurodevelopmental disorder.
• 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.

You may not qualify if:

• Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.

Sponsors & Collaborators

• Brightlobe Limited: lead

Study Sites (1)

Brightlobe Limited

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Dyslexia; Specific Learning Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Iles, PhD DClinPsy

  Brightlobe Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Lamba

CONTACT

+447872989457; study@brightlobe.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 23, 2023
• Study Start: January 30, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

GB (1)