Estimating Premorbid Intellectual Functioning in Children and Measuring Change in Cognitive Functioning as Children Develop

NCT ID: NCT04153838

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Child Development Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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+).

Cognitive test administration

Intervention Type OTHER

Specifically chosen cognitive tests will be administered to all participants twice; with an approximate 12 month gap between initial testing and follow-up testing.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Grampian

OTHER_GOV

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Downey

Role: PRINCIPAL_INVESTIGATOR

NHS Grampian

Locations

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Royal Aberdeen Children's Hospital

Aberdeen, UK, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Bruce Downey

Role: CONTACT

+44 1224 552234

Other Identifiers

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1-064-19

Identifier Type: -

Identifier Source: org_study_id

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