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

NCT04153838 | Enrolling By Invitation DMC

• 1 other identifier: 1-064-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development; Cognitive Impairment

Keywords

Neuropsychology

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline

• 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

  12 months

Study Arms (1)

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

Cognitive test administration 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.

Children

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Royal Aberdeen Children's Hospital

Aberdeen, UK, AB25 2ZH, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bruce Downey

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: October 31, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)