Estimating Premorbid Intellectual Functioning in Children and Measuring Change in Cognitive Functioning as Children Develop
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|ClinicalTrials.gov Identifier: NCT04153838|
Recruitment Status : Suspended (Due to covid-19 restrictions on recruiting)
First Posted : November 6, 2019
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment|
|Child Development Cognitive Impairment||Other: Cognitive test administration|
Neurological injury and disease can substantially affect how children's brains work. This can severely impair cognitive abilities and general development. On a day-to-day level, completing everyday tasks, socialising successfully with peers, and getting on with school work can become much more difficult than it was before.
Helpfully, supports and treatments are available that can reduce the negative effects of neurological impairment on a child's cognitive functioning in order to maximise developmental outcomes. However, to deliver appropriate interventions, we must correctly estimate the impact of injury or illness on cognitive abilities and accurately measure how successful treatments are at improving outcomes. Unfortunately, reliable ways of doing this simply do not exist at this time. Consequently, accurate disease (effects) monitoring is seriously undermined; potentially compromising a child's medical management and, thereby, future developmental outcomes.
This study intends to addresses this grave shortcoming by developing reliable ways of measuring the cognitive effects of neurological disease or injury at diagnosis and beyond. Of note, by providing a mechanism to better inform clinical/medical management decisions, completion of this study will help contribute to health and social care aims of enabling children to realise their developmental potential.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Estimating Premorbid Intellectual Functioning in the Paediatric Population and Developing a Reliable Means for Quantifying Abnormal Change in Cognitive Functions as Children Develop|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
A group of 'typically' developing children (aged between 6 years and 16 years 11 months) from the general paediatric population will be recruited; with the sample distributed evenly across 6 age bands (i.e. ages 6-7 years, 8-9 years, 10-11 years, 12-13 years, 14-15 years, and 16 years+).
Other: Cognitive test administration
Specifically chosen cognitive tests will be administered to all participants twice; with an approximate 12 month gap between initial testing and follow-up testing.
- Obtained intelligence quotient (IQ) score [ Time Frame: Baseline ]A child's obtained Full Scale IQ score from a standardised assessment of intelligence constitutes the main outcome variable for this study
- Change in obtained intelligence quotient (IQ) score (at 12 month follow-up) [ Time Frame: 12 months ]A child's obtained Full Scale IQ score at 12 months follow-up also constitutes a main outcome variable for this study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153838
|Royal Aberdeen Children's Hospital|
|Aberdeen, Please Select Region, State Or Province, United Kingdom, AB25 2ZH|
|Principal Investigator:||Bruce Downey||NHS Grampian|