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Clinical Trials/NCT06330090
NCT06330090
Recruiting
N/A

Cognitive Dynamics in Early Childhood

Radboud University Medical Center1 site in 1 country600 target enrollmentNovember 18, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Change
Sponsor
Radboud University Medical Center
Enrollment
600
Locations
1
Primary Endpoint
pupil dilation during reasoning task at baseline
Status
Recruiting
Last Updated
last year

Overview

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?
Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
December 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

MP-RAGE MRI sequence follow up

Time Frame: 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

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)

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.

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.

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.

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.

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.

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.

Sparse MP2-Rage MRI sequence baseline

Time Frame: an average of 1 year

Structural Sparse MP2-Rage MRI scan at baseline measurement

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

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.

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.

MP-RAGE MRI sequence baseline

Time Frame: 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

Time Frame: 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

Time Frame: two years after baseline

Structural Sparse MP2-Rage MRI scan at follow up measurement

Diffusion weighted imaging MRI sequence follow up

Time Frame: two years after baseline

Diffusion weighted imaging MRI scan at follow up measurement

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.

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.

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.

Naturalistic viewing fMRI at baseline

Time Frame: an average of 1 year

Naturalistic viewing fMRI at baseline measurement.

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.

Diffusion weighted imaging MRI sequence baseline

Time Frame: an average of 1 year

Diffusion weighted imaging MRI scan at baseline measurement

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.

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)

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)

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

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.

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.

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.

Naturalistic viewing fMRI at follow-up

Time Frame: two years after baseline

Naturalistic viewing fMRI at follow-up measurement.

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)

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.

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)

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)

Secondary Outcomes

  • Decibel of background noise during cognitive testing(Through study completion, an average of 3 years)
  • motivation rating for cognitive tasks(Through study completion, an average of 3 years)
  • Parent reaction times on cognitive battery at baseline(an average of 1 year)
  • Academic school result follow-up(two years after baseline)
  • Academic school result baseline(an average of 1 year)
  • Parent reaction times on cognitive battery at follow-up(two years after baseline)

Study Sites (1)

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