- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06330090
COgnitive Dynamics in Early Childhood (CODEC)
Cognitive Dynamics in Early Childhood
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:
- How does cognitive variability differ between individuals?
- What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
- What are the long-term consequences and outcomes associated with differences in cognitive variability?
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rogier Kievit
- Phone Number: +31 (0) 24 361 42 24
- Email: rogier.kievit@donders.ru.nl
Study Contact Backup
- Name: Ilse Coolen
- Email: ilse.coolen@radboudumc.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Design
Behavioural or behavioural with imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction times from the vocabulary cognitive task
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Reaction times from the exploration cognitive task
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Reaction times from the Working Memory cognitive task
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Reaction times from the speed cognitive task
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Reaction times from the fluid reasoning cognitive task
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Mood score on smiley slider
Time Frame: 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.
|
Through study completion, an average of 3 years
|
Sleep score on smiley slider
Time Frame: 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.
|
Through study completion, an average of 3 years
|
MP-RAGE MRI sequence baseline
Time Frame: an average of 1 year
|
Structural MP-RAGE MRI scan at baseline measurement
|
an average of 1 year
|
Functional MRI sequence of low time constraint reasoning task at baseline
Time Frame: an average of 1 year
|
Functional MRI scan at baseline measurement when participants perform fluid reasoning task with low time contraint.
|
an average of 1 year
|
gaze direction during reasoning task at baseline
Time Frame: an average of 1 year
|
gaze direction recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
|
an average of 1 year
|
pupil dilation during reasoning task at baseline
Time Frame: an average of 1 year
|
pupil dilation recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
|
an average of 1 year
|
Naturalistic viewing fMRI at baseline
Time Frame: an average of 1 year
|
Naturalistic viewing fMRI at baseline measurement.
|
an average of 1 year
|
Naturalistic viewing fMRI at follow-up
Time Frame: two years after baseline
|
Naturalistic viewing fMRI at follow-up measurement.
|
two years after baseline
|
Functional MRI sequence of high time constraint reasoning task at follow-up
Time Frame: two years after baseline
|
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with high time contraint.
|
two years after baseline
|
gaze direction during reasoning task at baseline at follow-up
Time Frame: two years after baseline
|
gaze direction recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
|
two years after baseline
|
pupil dilation during reasoning task at baseline at follow-up
Time Frame: two years after baseline
|
pupil dilation recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
|
two years after baseline
|
Functional MRI sequence of low time constraint reasoning task at follow-up
Time Frame: two years after baseline
|
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with low time contraint.
|
two years after baseline
|
Sparse MP2-Rage MRI sequence baseline
Time Frame: an average of 1 year
|
Structural Sparse MP2-Rage MRI scan at baseline measurement
|
an average of 1 year
|
Diffusion weighted imaging MRI sequence baseline
Time Frame: an average of 1 year
|
Diffusion weighted imaging MRI scan at baseline measurement
|
an average of 1 year
|
MP-RAGE MRI sequence follow up
Time Frame: two years after baseline
|
Structural MP-RAGE MRI scan at follow up measurement
|
two years after baseline
|
Sparse MP2-Rage MRI sequence follow up
Time Frame: two years after baseline
|
Structural Sparse MP2-Rage MRI scan at follow up measurement
|
two years after baseline
|
Diffusion weighted imaging MRI sequence follow up
Time Frame: two years after baseline
|
Diffusion weighted imaging MRI scan at follow up measurement
|
two years after baseline
|
Total score for Highly Sensitive Child scale at baseline
Time Frame: 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
|
an average of 1 year
|
Total score for Strengths and difficulties questionnaire at baseline
Time Frame: 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)
|
an average of 1 year
|
Total score for BRIEF-2 questionnaire at baseline
Time Frame: an average of 1 year
|
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at baseline.
|
an average of 1 year
|
Total score for BRIEF-2 questionnaire at follow-up
Time Frame: two years after baseline
|
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at follow-up.
|
two years after baseline
|
Total score for Strengths and difficulties questionnaire at follow-up
Time Frame: 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)
|
two years after baseline
|
Total score for Mind Excessively Wandering Scale scale at baseline
Time Frame: 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)
|
an average of 1 year
|
Originality score for the Alternative Uses Tasks at baseline
Time Frame: an average of 1 year
|
Originality score of responses on an alternative uses task at baseline.
|
an average of 1 year
|
Originality score for the Alternative Uses Tasks at follow-up
Time Frame: two years after baseline
|
Originality score of responses on an alternative uses task at follow-up.
|
two years after baseline
|
Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline
Time Frame: 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)
|
an average of 1 year
|
Total score for Parent-reported Socio-demographic questionnaire at baseline
Time Frame: 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.
|
an average of 1 year
|
Total score for Parent-reported Socio-demographic questionnaire at follow-up
Time Frame: 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.
|
two years after baseline
|
Total score for Mind Excessively Wandering Scale scale at follow-up
Time Frame: 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)
|
two years after baseline
|
Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up
Time Frame: 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)
|
two years after baseline
|
Total score for Highly Sensitive Child scale at follow-up
Time Frame: 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
|
two years after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motivation rating for cognitive tasks
Time Frame: 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
|
Through study completion, an average of 3 years
|
Decibel of background noise during cognitive testing
Time Frame: Through study completion, an average of 3 years
|
DB recording of background noise when performing the cognitive tasks at the start of the testing
|
Through study completion, an average of 3 years
|
Academic school result baseline
Time Frame: an average of 1 year
|
cito-scores, academic results on national test obtained through schools at baseline
|
an average of 1 year
|
Academic school result follow-up
Time Frame: two years after baseline
|
cito-scores, academic results on national test obtained through schools at follow-up
|
two years after baseline
|
Parent reaction times on cognitive battery at baseline
Time Frame: 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
|
an average of 1 year
|
Parent reaction times on cognitive battery at follow-up
Time Frame: 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
|
two years after baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL84688.091.23
- 101040534 (Other Grant/Funding Number: European Research Council)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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