Neurodevelopmental DisordersBRIGHTENNCT05780853
A Game-based Neurodevelopmental Assessment for Young Children
An observational study of Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Brightlobe Limited at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Tablet Game-based Assessment - YARN assessment service, Adaptive Behavior Assessment System, Third Edition (ABAS-3) and Demographic questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 590 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Brightlobe Limited
London
Shivani Lamba, study@brightlobe.com
About this study
Official title: 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.
Read more
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
- Being tested
- Tablet Game-based Assessment - YARN assessment service, Adaptive Behavior Assessment System, Third Edition (ABAS-3), Demographic questionnaire
- Keywords
- Diagnostic test, Neurodevelopment, Medical technology
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Dyslexia, Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet Game-based Assessment - YARN assessment serviceDiagnostic 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 questionnaireOther
Parent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Tablet Game-based Assessment - YARN assessment service; Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Other: Demographic questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the tablet game-based assessment
Sensitivity and specificity of the tablet game-based assessment to accurately differentiate children's neurodevelopmental status.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months
Secondary outcomes (4)
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.
Measured: 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?).
Measured: 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.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start30 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightlobe Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Iles, PhD DClinPsy, Principal investigator, Brightlobe Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780853
- Sponsor's protocol ID
- BRIGHTEN-01
- Acronym
- BRIGHTEN
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Game-based Neurodevelopmental Assessment for Young Children
- ClinicalTrials.gov ID
- NCT05780853
- Acronym / sponsor ID
- BRIGHTEN / BRIGHTEN-01
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Dyslexia, Specific Learning Disorder, Child Development
- Keywords
- Diagnostic test, Neurodevelopment, Medical technology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Brightlobe LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically Developing Children (Control Group) | – | Diagnostic Test: Tablet Game-based Assessment - YARN assessment service, Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Other: Demographic questionnaireTypically 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. |
| Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group) | – | Diagnostic Test: Tablet Game-based Assessment - YARN assessment service, Diagnostic Test: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Other: Demographic questionnaireChildren 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet Game-based Assessment - YARN assessment serviceTablet game-based assessment to assess neurodevelopmental profile. | Diagnostic test | Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group), Typically Developing Children (Control Group) |
| 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. | Diagnostic test | Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group), Typically Developing Children (Control Group) |
| Demographic questionnaireParent/carer and child's demographic data such as age, ethnicity, employment status, household income, medical history and education status. | Other | Children with a Diagnosed Neurodevelopmental Disorder (Clinical Group), Typically Developing Children (Control Group) |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Preliminary normative data for performance on the tablet game-based assessment tool
Time frame: 16 months
Acceptability of the tablet game-based assessment tool and device
Time frame: 16 months
Re-test reliability of the tablet game-based assessment tool
Time frame: 16 months
Safety of the tablet game-based assessment tool and device
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Iles, PhD DClinPsy principal investigator
Brightlobe Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Brightlobe Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shivani Lamba (+447872989457, study@brightlobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the tablet game-based assessment (time frame: 16 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.