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COgnitive Dynamics in Early Childhood

Cognitive Dynamics in Early Childhood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06330090
Acronym
CODEC
Enrollment
600
Registered
2024-03-26
Start date
2024-11-18
Completion date
2027-12-31
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

Keywords

cognition

Brief summary

The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions: 1. How does cognitive variability differ between individuals? 2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability? 3. What are the long-term consequences and outcomes associated with differences in cognitive variability?

Interventions

None listed

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* In order to be eligible to participate in the behavioural arm of this study, a subject must meet all of the following criteria: * Between the ages of 7 and 10 years at the moment of the first assessment. In order to be eligible to participate in the imaging arm of this study, a subject must meet all of the following criteria: * Between the ages of 8 and 10 years at the moment of the first assessment.

Exclusion criteria

* A potential subject will be excluded from participation in the study if the participant indicates not understanding the instructions of the behavioural tasks due to a language barrier. In the imaging arm of the study, a potential subject who meets any of the following criteria will further be excluded from participation in the imaging arm of the study: * History of neurological or psychiatric illness. * History of using psychotropic medications. * Contraindications for MRI. * Metal parts that cannot be removed, are present in or on upper body, e.g. plates, screws, aneurysm clips, metal splinters, piercings or medical plasters. (exception: dental fillings, crowns, a metal wire behind the teeth, tattoos and contraceptive coils). * Body containing metal fragments, in particular in the eye, e.g., caused by injuries when working with metal. * History of brain surgery. * Active implant(s) (e.g. pacemaker, neurostimulator, insulin pump, ossicle prosthesis) * Using a medical plaster that cannot or may not be taken off (e.g. nicotine plaster)

Design outcomes

Primary

MeasureTime frameDescription
Total score for Highly Sensitive Child scale at follow-uptwo years after baselineParticipant-reported 12-item Dutch version of the HSC scale measured at follow-up. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
Originality score for the Alternative Uses Tasks at follow-uptwo years after baselineOriginality score of responses on an alternative uses task at follow-up.
Total score for Parent-reported Mind Excessively Wandering Scale scale at baselinean average of 1 yearParent reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Total score for Parent-reported Socio-demographic questionnaire at baselinean average of 1 yearParent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of educationm professional situation) will be measured.
Total score for Parent-reported Socio-demographic questionnaire at follow-uptwo years after baselineParent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of education, professional situation) will be measured.
Total score for Mind Excessively Wandering Scale scale at follow-uptwo years after baselineParticipant reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-uptwo years after baselineParent reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
pupil dilation during reasoning task at baselinean average of 1 yearpupil dilation recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Naturalistic viewing fMRI at baselinean average of 1 yearNaturalistic viewing fMRI at baseline measurement.
Reaction times from the vocabulary cognitive taskThrough study completion, an average of 3 yearsRT from accurate responses from the vocabulary task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the exploration cognitive taskThrough study completion, an average of 3 yearsRT from accurate responses from the exploration task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the Working Memory cognitive taskThrough study completion, an average of 3 yearsRT from accurate responses from the WM task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the speed cognitive taskThrough study completion, an average of 3 yearsRT from accurate responses from the speed raction time task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the fluid reasoning cognitive taskThrough study completion, an average of 3 yearsRT from accurate responses from the fluid reasoning task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Mood score on smiley sliderThrough study completion, an average of 3 yearsThe current mood of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Sleep score on smiley sliderThrough study completion, an average of 3 yearsThe current level of tiredness of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
MP-RAGE MRI sequence baselinean average of 1 yearStructural MP-RAGE MRI scan at baseline measurement
Functional MRI sequence of low time constraint reasoning task at baselinean average of 1 yearFunctional MRI scan at baseline measurement when participants perform fluid reasoning task with low time contraint.
gaze direction during reasoning task at baselinean average of 1 yeargaze direction recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Naturalistic viewing fMRI at follow-uptwo years after baselineNaturalistic viewing fMRI at follow-up measurement.
Functional MRI sequence of high time constraint reasoning task at follow-uptwo years after baselineFunctional MRI scan at follow-up measurement when participants perform fluid reasoning task with high time contraint.
gaze direction during reasoning task at baseline at follow-uptwo years after baselinegaze direction recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
pupil dilation during reasoning task at baseline at follow-uptwo years after baselinepupil dilation recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Functional MRI sequence of low time constraint reasoning task at follow-uptwo years after baselineFunctional MRI scan at follow-up measurement when participants perform fluid reasoning task with low time contraint.
Sparse MP2-Rage MRI sequence baselinean average of 1 yearStructural Sparse MP2-Rage MRI scan at baseline measurement
Diffusion weighted imaging MRI sequence baselinean average of 1 yearDiffusion weighted imaging MRI scan at baseline measurement
MP-RAGE MRI sequence follow uptwo years after baselineStructural MP-RAGE MRI scan at follow up measurement
Sparse MP2-Rage MRI sequence follow uptwo years after baselineStructural Sparse MP2-Rage MRI scan at follow up measurement
Diffusion weighted imaging MRI sequence follow uptwo years after baselineDiffusion weighted imaging MRI scan at follow up measurement
Total score for Highly Sensitive Child scale at baselinean average of 1 yearParticipant reported 12-item Dutch version of the HSC scale measured at baseline. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
Total score for Strengths and difficulties questionnaire at baselinean average of 1 yearParent reported 25-item Dutch version of the SDQ measured at baseline. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Total score for BRIEF-2 questionnaire at baselinean average of 1 yearParent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at baseline.
Total score for BRIEF-2 questionnaire at follow-uptwo years after baselineParent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at follow-up.
Total score for Strengths and difficulties questionnaire at follow-uptwo years after baselineParent reported 25-item Dutch version of the SDQ measured at follow-up. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Total score for Mind Excessively Wandering Scale scale at baselinean average of 1 yearParticipant reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Originality score for the Alternative Uses Tasks at baselinean average of 1 yearOriginality score of responses on an alternative uses task at baseline.

Secondary

MeasureTime frameDescription
Decibel of background noise during cognitive testingThrough study completion, an average of 3 yearsDB recording of background noise when performing the cognitive tasks at the start of the testing
Academic school result baselinean average of 1 yearcito-scores, academic results on national test obtained through schools at baseline
Academic school result follow-uptwo years after baselinecito-scores, academic results on national test obtained through schools at follow-up
Parent reaction times on cognitive battery at baselinean average of 1 yearParents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at baseline
Parent reaction times on cognitive battery at follow-uptwo years after baselineParents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at follow-up
motivation rating for cognitive tasksThrough study completion, an average of 3 yearsRating from least to most fun cognitive task once a year after completing the cognitie battery 10 times in the burst week

Countries

Netherlands

Contacts

Primary ContactRogier Kievit
rogier.kievit@donders.ru.nl+31 (0) 24 361 42 24
Backup ContactIlse Coolen
ilse.coolen@radboudumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026