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Enrolling by invitationNCT04153838Updated May 6, 2026

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

An observational study in Child Development and Cognitive Impairment, sponsored by University of Aberdeen. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Aberdeen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Development
  • Cognitive Impairment

Keywords

  • Neuropsychology
03

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherCognitive 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.

05

What researchers measure

Primary outcomes

  1. Obtained intelligence quotient (IQ) score

    A child's obtained Full Scale IQ score from a standardised assessment of intelligence constitutes the main outcome variable for this study

    Time frame: Baseline

  2. Change in obtained intelligence quotient (IQ) score (at 12 month follow-up)

    A child's obtained Full Scale IQ score at 12 months follow-up also constitutes a main outcome variable for this study

    Time frame: 12 months

06

Study locations

1 site
  • Royal Aberdeen Children's Hospital
    Aberdeen, UK AB25 2ZH, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04153838
Lead sponsor
University of Aberdeen
Collaborators
NHS Grampian
Responsible party
Sponsor
First posted
Nov 6, 2019
Start date
Oct 31, 2019
Primary completion
Aug 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 6, 2026

Study contacts

Bruce Downey
principal investigator · NHS Grampian

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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