Clinical trial NCT06330090: COgnitive Dynamics in Early Childhood
Official title: Cognitive Dynamics in Early Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Change
Keywords: cognition
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?


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)

Primary outcomes:
measure: Reaction times from the vocabulary cognitive task
timeFrame: Through study completion, an average of 3 years
measure: Reaction times from the exploration cognitive task
timeFrame: Through study completion, an average of 3 years
measure: Reaction times from the Working Memory cognitive task
timeFrame: Through study completion, an average of 3 years
measure: Reaction times from the speed cognitive task
timeFrame: Through study completion, an average of 3 years
measure: Reaction times from the fluid reasoning cognitive task
timeFrame: Through study completion, an average of 3 years
measure: Mood score on smiley slider
timeFrame: Through study completion, an average of 3 years
measure: Sleep score on smiley slider
timeFrame: Through study completion, an average of 3 years
measure: MP-RAGE MRI sequence baseline
timeFrame: an average of 1 year
measure: Functional MRI sequence of low time constraint reasoning task at baseline
timeFrame: an average of 1 year
measure: gaze direction during reasoning task at baseline
timeFrame: an average of 1 year
measure: pupil dilation during reasoning task at baseline
timeFrame: an average of 1 year
measure: Naturalistic viewing fMRI at baseline
timeFrame: an average of 1 year
measure: Naturalistic viewing fMRI at follow-up
timeFrame: two years after baseline
measure: Functional MRI sequence of high time constraint reasoning task at follow-up
timeFrame: two years after baseline
measure: gaze direction during reasoning task at baseline at follow-up
timeFrame: two years after baseline
measure: pupil dilation during reasoning task at baseline at follow-up
timeFrame: two years after baseline
measure: Functional MRI sequence of low time constraint reasoning task at follow-up
timeFrame: two years after baseline
measure: Sparse MP2-Rage MRI sequence baseline
timeFrame: an average of 1 year
measure: Diffusion weighted imaging MRI sequence baseline
timeFrame: an average of 1 year
measure: MP-RAGE MRI sequence follow up
timeFrame: two years after baseline
measure: Sparse MP2-Rage MRI sequence follow up
timeFrame: two years after baseline
measure: Diffusion weighted imaging MRI sequence follow up
timeFrame: two years after baseline
measure: Total score for Highly Sensitive Child scale at baseline
timeFrame: an average of 1 year
measure: Total score for Strengths and difficulties questionnaire at baseline
timeFrame: an average of 1 year
measure: Total score for BRIEF-2 questionnaire at baseline
timeFrame: an average of 1 year
measure: Total score for BRIEF-2 questionnaire at follow-up
timeFrame: two years after baseline
measure: Total score for Strengths and difficulties questionnaire at follow-up
timeFrame: two years after baseline
measure: Total score for Mind Excessively Wandering Scale scale at baseline
timeFrame: an average of 1 year
measure: Originality score for the Alternative Uses Tasks at baseline
timeFrame: an average of 1 year
measure: Originality score for the Alternative Uses Tasks at follow-up
timeFrame: two years after baseline
measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline
timeFrame: an average of 1 year
measure: Total score for Parent-reported Socio-demographic questionnaire at baseline
timeFrame: an average of 1 year
measure: Total score for Parent-reported Socio-demographic questionnaire at follow-up
timeFrame: two years after baseline
measure: Total score for Mind Excessively Wandering Scale scale at follow-up
timeFrame: two years after baseline
measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up
timeFrame: two years after baseline
measure: Total score for Highly Sensitive Child scale at follow-up
timeFrame: two years after baseline
Secondary outcomes:
measure: motivation rating for cognitive tasks
timeFrame: Through study completion, an average of 3 years
measure: Decibel of background noise during cognitive testing
timeFrame: Through study completion, an average of 3 years
measure: Academic school result baseline
timeFrame: an average of 1 year
measure: Academic school result follow-up
timeFrame: two years after baseline
measure: Parent reaction times on cognitive battery at baseline
timeFrame: an average of 1 year
measure: Parent reaction times on cognitive battery at follow-up
timeFrame: two years after baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc Department of Cognitive Neuroscience
Study officials:
References: