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NCT Number: NCT06330090

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:

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?

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Key information

Conditions

Cognitive Change

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc Department of Cognitive Neuroscience

Nijmegen, 6525 EN, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. MP-RAGE MRI sequence baseline

    Time frame: an average of 1 year

    Structural MP-RAGE MRI scan at baseline measurement

  9. 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.

  10. 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.

  11. 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.

  12. Naturalistic viewing fMRI at baseline

    Time frame: an average of 1 year

    Naturalistic viewing fMRI at baseline measurement.

  13. Naturalistic viewing fMRI at follow-up

    Time frame: two years after baseline

    Naturalistic viewing fMRI at follow-up measurement.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Sparse MP2-Rage MRI sequence baseline

    Time frame: an average of 1 year

    Structural Sparse MP2-Rage MRI scan at baseline measurement

  19. Diffusion weighted imaging MRI sequence baseline

    Time frame: an average of 1 year

    Diffusion weighted imaging MRI scan at baseline measurement

  20. MP-RAGE MRI sequence follow up

    Time frame: two years after baseline

    Structural MP-RAGE MRI scan at follow up measurement

  21. Sparse MP2-Rage MRI sequence follow up

    Time frame: two years after baseline

    Structural Sparse MP2-Rage MRI scan at follow up measurement

  22. Diffusion weighted imaging MRI sequence follow up

    Time frame: two years after baseline

    Diffusion weighted imaging MRI scan at follow up measurement

  23. 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

  24. 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)

  25. 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.

  26. 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.

  27. 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)

  28. 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)

  29. 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.

  30. 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.

  31. 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)

  32. 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.

  33. 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.

  34. 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)

  35. 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)

  36. 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

Secondary outcomes

  1. 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

  2. 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

  3. Academic school result baseline

    Time frame: an average of 1 year

    cito-scores, academic results on national test obtained through schools at baseline

  4. Academic school result follow-up

    Time frame: two years after baseline

    cito-scores, academic results on national test obtained through schools at follow-up

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ilse Coolen

CONTACT

[email protected]

Rogier Kievit

CONTACT

[email protected]

+31 (0) 24 361 42 24

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: CODEC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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