Actively Recruiting

Age: 3Years - 8Years
All Genders
Healthy Volunteers
ID05780853

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

Led by Brightlobe Limited · Updated on 2024-07-25

590

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new tablet game-based tool designed to assess neurodevelopment in young children aged 3 to 8 years. This study aims to determine if the game can accurately distinguish between typically developing children and those with neurodevelopmental disorders such as ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or Communication Disorder. It also seeks to assess how valid and reliable the game-based assessment is for evaluating a child's neuropsychological functions. Participants will complete the tablet game-based assessment, which evaluates attention, memory, language, motor skills, executive functions, and social-emotional abilities. Parents or caregivers will fill out a demographic questionnaire and the Adaptive Behavior Assessment System, Third Edition (ABAS-3), to provide additional developmental information. Some children may be asked to repeat the game assessment about two weeks later to check the consistency and validity of the tool. Children's involvement includes playing the game-based assessment and having their caregivers complete questionnaires about their development and background. The study will measure diagnostic accuracy, validity, internal consistency, predictive validity, and safety of the assessment over a period of 16 months. Researchers will also collect preliminary normative data, evaluate the acceptability of the tool, and assess test-retest reliability to ensure the assessment's usefulness and safety throughout the study.

CONDITIONS

Brief Title

A Game-based Neurodevelopmental Assessment for Young Children

Who Can Participate

Age: 3Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 8 years who are typically developing with no known neurodevelopmental disorders
  • Children aged 3 to 8 years diagnosed with ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or a Communication Disorder
  • Parents/caregivers and children must have sufficient English fluency to complete the assessments
Not Eligible

You will not qualify if you...

  • Children with medical comorbidities or chronic illnesses
  • Children with any other diagnoses that would affect their ability to complete the game-based assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - One-time assessment

Participants complete a tablet game-based assessment and parent-reported behavioral questionnaires to evaluate neurodevelopmental profiles.

1 visit (in-person)

Long-term Monitoring

Duration - 16 months

Participants are observed over 16 months to assess the diagnostic accuracy and validity of the game-based assessment tool.

Trial Site Locations

Total: 1 location

1

Brightlobe Limited

London, United Kingdom

Actively Recruiting

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Research Team

S

Shivani Lamba

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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