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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
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

Study Description
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Brief Summary:
Diagnosing and documenting the presence of abnormal change in cognitive functions (such as reasoning abilities) in children over time is of upmost importance when it comes to evaluating the impact of neurological injury, disease, and interventions designed to help improve wellbeing. Unfortunately however, current methods for detecting cognitive impairment and monitoring for abnormal cognitive change in children over time are seriously flawed. By assessing typically developing children's cognitive functioning at two different time points, this study intends to generate new normative data that will significantly improve measurement accuracy when it comes to evaluating the impact of neurological injury and disease on a child's cognitive abilities.

Condition or disease Intervention/treatment
Child Development Cognitive Impairment Other: Cognitive test administration

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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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+).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A group of schoolchildren (aged between 6 years and 16 years 11 months) from the general paediatric population will be recruited
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Please Select Region, State Or Province, United Kingdom, AB25 2ZH
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Bruce Downey NHS Grampian
More Information
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT04153838    
Other Study ID Numbers: 1-064-19
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aberdeen:
Neuropsychology
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders