COgnitive Dynamics in Early Childhood
- Conditions
- Cognitive Change
- Registration Number
- NCT06330090
- Lead Sponsor
- Radboud University Medical Center
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
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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.
-
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pupil dilation during reasoning task at baseline an average of 1 year pupil dilation recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Functional MRI sequence of low time constraint reasoning task at follow-up two years after baseline Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with low time contraint.
MP-RAGE MRI sequence follow up two years after baseline Structural MP-RAGE MRI scan at follow up measurement
Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline an average of 1 year Parent 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 follow-up two years after baseline Parent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of education, professional situation) will be measured.
Reaction times from the vocabulary cognitive task Through study completion, an average of 3 years RT 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 task Through study completion, an average of 3 years RT 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 task Through study completion, an average of 3 years RT 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.
Functional MRI sequence of low time constraint reasoning task at baseline an average of 1 year Functional MRI scan at baseline measurement when participants perform fluid reasoning task with low time contraint.
pupil dilation during reasoning task at baseline at follow-up two years after baseline pupil dilation recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Sparse MP2-Rage MRI sequence baseline an average of 1 year Structural Sparse MP2-Rage MRI scan at baseline measurement
Total score for Highly Sensitive Child scale at baseline an average of 1 year Participant 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
Reaction times from the fluid reasoning cognitive task Through study completion, an average of 3 years RT 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.
MP-RAGE MRI sequence baseline an average of 1 year Structural MP-RAGE MRI scan at baseline measurement
Functional MRI sequence of high time constraint reasoning task at follow-up two years after baseline Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with high time contraint.
Sparse MP2-Rage MRI sequence follow up two years after baseline Structural Sparse MP2-Rage MRI scan at follow up measurement
Diffusion weighted imaging MRI sequence follow up two years after baseline Diffusion weighted imaging MRI scan at follow up measurement
Originality score for the Alternative Uses Tasks at baseline an average of 1 year Originality score of responses on an alternative uses task at baseline.
Originality score for the Alternative Uses Tasks at follow-up two years after baseline Originality score of responses on an alternative uses task at follow-up.
Mood score on smiley slider Through study completion, an average of 3 years The 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 slider Through study completion, an average of 3 years The 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.
Naturalistic viewing fMRI at baseline an average of 1 year Naturalistic viewing fMRI at baseline measurement.
gaze direction during reasoning task at baseline at follow-up two years after baseline gaze direction recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Diffusion weighted imaging MRI sequence baseline an average of 1 year Diffusion weighted imaging MRI scan at baseline measurement
Total score for BRIEF-2 questionnaire at baseline an average of 1 year Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at baseline.
Total score for Strengths and difficulties questionnaire at follow-up two years after baseline Parent 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 baseline an average of 1 year Participant 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 Highly Sensitive Child scale at follow-up two years after baseline Participant-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
gaze direction during reasoning task at baseline an average of 1 year gaze direction recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Reaction times from the speed cognitive task Through study completion, an average of 3 years RT 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.
Naturalistic viewing fMRI at follow-up two years after baseline Naturalistic viewing fMRI at follow-up measurement.
Total score for Strengths and difficulties questionnaire at baseline an average of 1 year Parent 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 follow-up two years after baseline Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at follow-up.
Total score for Parent-reported Socio-demographic questionnaire at baseline an average of 1 year Parent 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 Mind Excessively Wandering Scale scale at follow-up two years after baseline Parent 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 Mind Excessively Wandering Scale scale at follow-up two years after baseline Participant 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)
- Secondary Outcome Measures
Name Time Method Decibel of background noise during cognitive testing Through study completion, an average of 3 years DB recording of background noise when performing the cognitive tasks at the start of the testing
motivation rating for cognitive tasks Through study completion, an average of 3 years Rating from least to most fun cognitive task once a year after completing the cognitie battery 10 times in the burst week
Parent reaction times on cognitive battery at baseline an average of 1 year Parents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at baseline
Academic school result follow-up two years after baseline cito-scores, academic results on national test obtained through schools at follow-up
Academic school result baseline an average of 1 year cito-scores, academic results on national test obtained through schools at baseline
Parent reaction times on cognitive battery at follow-up two years after baseline Parents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at follow-up