ClinicalTrials.gg
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

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
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

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 176 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 will likewise be excluded
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

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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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Aug 2026, 82 months after the start.

Of 504 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 82 months is above that.

Counting every sponsor, half of 543 studies reached it within 47 months; a quarter within 21 and three quarters within 118.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2019
First posted
Nov 6, 2019
StartActual
Oct 31, 2019
Primary completionEst.
Aug 2026
CompletionEst.
Dec 2026
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04153838
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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No contact was published for this record. The registry link below has the sponsor’s details.

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