COgnitive Dynamics in Early Childhood

NCT06330090 | Recruiting

• 2 other identifiers: NL84688.091.23101040534
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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. 1.How does cognitive variability differ between individuals?
2. 2.What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
3. 3.What are the long-term consequences and outcomes associated with differences in cognitive variability?

Conditions

Cognitive Change

Keywords

cognition

Outcome Measures

Primary Outcomes (36)

• Reaction times from the vocabulary cognitive task

  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

  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

  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

  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

  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

  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

  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

  Structural MP-RAGE MRI scan at baseline measurement

  an average of 1 year

• Functional MRI sequence of low time constraint reasoning task at baseline

  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

  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

  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

  Naturalistic viewing fMRI at baseline measurement.

  an average of 1 year

• Naturalistic viewing fMRI at follow-up

  Naturalistic viewing fMRI at follow-up measurement.

  two years after baseline

• Functional MRI sequence of high time constraint reasoning task at follow-up

  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

  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

  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

  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

  Structural Sparse MP2-Rage MRI scan at baseline measurement

  an average of 1 year

• Diffusion weighted imaging MRI sequence baseline

  Diffusion weighted imaging MRI scan at baseline measurement

  an average of 1 year

• MP-RAGE MRI sequence follow up

  Structural MP-RAGE MRI scan at follow up measurement

  two years after baseline

• Sparse MP2-Rage MRI sequence follow up

  Structural Sparse MP2-Rage MRI scan at follow up measurement

  two years after baseline

• Diffusion weighted imaging MRI sequence follow up

  Diffusion weighted imaging MRI scan at follow up measurement

  two years after baseline

• Total score for Highly Sensitive Child scale at baseline

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (6)

• motivation rating for cognitive tasks

  Through study completion, an average of 3 years

• Decibel of background noise during cognitive testing

  Through study completion, an average of 3 years

• Academic school result baseline

  an average of 1 year

• Academic school result follow-up

  two years after baseline

• Parent reaction times on cognitive battery at baseline

  an average of 1 year

Study Arms (1)

Design

Behavioural or behavioural with imaging

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

600 children will be recruited from schools and on individual bases to take part in the behavioural testing. A subgroup of 200 children will be further recruited to participate in the imaging part of the study at the Donders Institute.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc Department of Cognitive Neuroscience

Nijmegen, 6525 EN, Netherlands

RECRUITING

Related Publications (1)

• Coolen IEJI, van Langen J, Hofman S, van Aagten FE, Schaaf JV, Michel L, Aristodemou M, Judd N, van Hout ATB, Meeussen E, Kievit RA. Protocol and preregistration for the CODEC project: measuring, modelling and mechanistically understanding the nature of cognitive variability in early childhood. BMC Psychol. 2024 Jul 26;12(1):407. doi: 10.1186/s40359-024-01904-5.

  PMID: 39060934 DERIVED

Central Study Contacts

Rogier Kievit

CONTACT

+31 (0) 24 361 42 24; rogier.kievit@donders.ru.nl

Ilse Coolen

CONTACT

ilse.coolen@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (1)