COgnitive Dynamics in Early Childhood

Cognitive Change Clinical Trial

— CODEC  

Official title:

Cognitive Dynamics in Early Childhood

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330090
• Other study ID #: NL84688.091.23
• Secondary ID: 101040534
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Radboud University Medical Center
• Contact: Rogier Kievit
• Phone: +31 (0) 24 361 42 24
• Email: rogier.kievit[@]donders.ru.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Change

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	MP-RAGE MRI sequence baseline	Structural MP-RAGE MRI scan at baseline measurement	an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	Naturalistic viewing fMRI at baseline	Naturalistic viewing fMRI at baseline measurement.	an average of 1 year
Primary	Naturalistic viewing fMRI at follow-up	Naturalistic viewing fMRI at follow-up measurement.	two years after baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Sparse MP2-Rage MRI sequence baseline	Structural Sparse MP2-Rage MRI scan at baseline measurement	an average of 1 year
Primary	Diffusion weighted imaging MRI sequence baseline	Diffusion weighted imaging MRI scan at baseline measurement	an average of 1 year
Primary	MP-RAGE MRI sequence follow up	Structural MP-RAGE MRI scan at follow up measurement	two years after baseline
Primary	Sparse MP2-Rage MRI sequence follow up	Structural Sparse MP2-Rage MRI scan at follow up measurement	two years after baseline
Primary	Diffusion weighted imaging MRI sequence follow up	Diffusion weighted imaging MRI scan at follow up measurement	two years after baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	motivation rating for cognitive tasks	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
Secondary	Decibel of background noise during cognitive testing	DB recording of background noise when performing the cognitive tasks at the start of the testing	Through study completion, an average of 3 years
Secondary	Academic school result baseline	cito-scores, academic results on national test obtained through schools at baseline	an average of 1 year
Secondary	Academic school result follow-up	cito-scores, academic results on national test obtained through schools at follow-up	two years after baseline
Secondary	Parent reaction times on cognitive battery at baseline	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
Secondary	Parent reaction times on cognitive battery at follow-up	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