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

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04153838
• Other study ID #: 1-064-19
• Status: Suspended
• Start date: November 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Please Select Region, State Or Province

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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