Brightlobe-Evaluation Study (BRIGHTEN)
Research type
Research Study
Full title
Evaluation of a novel game-based neurodevelopmental assessment for young children
IRAS ID
292577
Contact name
Jane Iles
Contact email
Sponsor organisation
Brightlobe Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Eudra Number, 2021-005091-19
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Childhood neurodevelopmental disorders, such as learning disabilities, autistic spectrum disorders and attention deficit hyperactivity disorder (ADHD), affect children’s functioning across a range of areas, and can lead to difficulties throughout a child’s life. Early diagnosis is essential in providing an understanding of these difficulties, ensuring access to support. \n\nHowever, neurodevelopmental diagnosis is a prolonged process. Existing task-based neurodevelopmental assessments for children are time-intensive and administration requires a high level of training. With the increase in digital healthcare and educational tools, there is a need to consider whether neurodevelopmental assessments can be conducted using digital games. \n\nThe study will seek to address this gap by evaluating the use of a new tablet-based neurodevelopmental assessment game. The main aim is to establish whether the new digital assessment can accurately distinguish children’s (3 to 8 years old) neurodevelopmental status. Children will be recruited from two groups: (1) those with a neurodevelopmental difficulty; and (2) typically-developing children. \n\nChildren will be recruited via early years and school settings, as well as through online parenting and support groups. Informed consent will be provided by parents/caregivers. Children will be asked to complete the neurodevelopmental assessment game on a tablet device at a research site. Participants will be asked if they are willing to complete the game on a second occasion, two weeks later. Each stage is expected to last approximately two hours. Caregivers will also be asked to complete one online questionnaire, taking approximately 30 minutes. \n\nThe data will be used to group the children based on their performance to determine whether the game can accurately identify the two groups. The study will also explore if the digital assessment is acceptable to children and caregivers. The validity and reliability of the assessment tool will also be explored. Finally, the safety of the device will also be evaluated.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
22/ES/0027
Date of REC Opinion
22 Jul 2022
REC opinion
Further Information Favourable Opinion