- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153838
Estimating Premorbid Intellectual Functioning in Children and Measuring Change in Cognitive Functioning as Children Develop
Estimating Premorbid Intellectual Functioning in the Paediatric Population and Developing a Reliable Means for Quantifying Abnormal Change in Cognitive Functions as Children Develop
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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UK
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Aberdeen, UK, United Kingdom, AB25 2ZH
- Royal Aberdeen Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participants must be aged between 6 years 0 months and 16 years 11 months 364 days
- Participants must be enrolled into a local mainstream school and have English as their first language
- Participants must not have sustained a previous brain-injury and not suffer from any other neurological illness (please see exclusion criteria below)
Exclusion Criteria:
- Individuals born significantly premature, that have a diagnosis of learning disability, a known neurological illness, or who have had a previous head-injury that required hospitalisation will be excluded from taking part in the study
- Individuals with a current mental health problem for which they are receiving treatment or those with substance misuse problems will also be excluded
- Participants unable to give informed consent will likewise be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children
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+).
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Specifically chosen cognitive tests will be administered to all participants twice; with an approximate 12 month gap between initial testing and follow-up testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Obtained intelligence quotient (IQ) score
Time Frame: Baseline
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A child's obtained Full Scale IQ score from a standardised assessment of intelligence constitutes the main outcome variable for this study
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Baseline
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Change in obtained intelligence quotient (IQ) score (at 12 month follow-up)
Time Frame: 12 months
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A child's obtained Full Scale IQ score at 12 months follow-up also constitutes a main outcome variable for this study
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce Downey, NHS Grampian
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-064-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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