Cognitive Dynamics in Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- pupil dilation during reasoning task at baseline
研究概览
简要总结
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:
- How does cognitive variability differ between individuals?
- What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
- What are the long-term consequences and outcomes associated with differences in cognitive variability?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
pupil dilation during reasoning task at baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: an average of 1 year
Structural Sparse MP2-Rage MRI scan at baseline measurement
Total score for Highly Sensitive Child scale at baseline
时间窗: 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
时间窗: an average of 1 year
Originality score of responses on an alternative uses task at baseline.
Reaction times from the fluid reasoning cognitive task
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: two years after baseline
Structural Sparse MP2-Rage MRI scan at follow up measurement
Diffusion weighted imaging MRI sequence follow up
时间窗: two years after baseline
Diffusion weighted imaging MRI scan at follow up measurement
Originality score for the Alternative Uses Tasks at follow-up
时间窗: two years after baseline
Originality score of responses on an alternative uses task at follow-up.
Mood score on smiley slider
时间窗: 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
时间窗: 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
时间窗: an average of 1 year
Naturalistic viewing fMRI at baseline measurement.
gaze direction during reasoning task at baseline at follow-up
时间窗: 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
时间窗: an average of 1 year
Diffusion weighted imaging MRI scan at baseline measurement
Total score for BRIEF-2 questionnaire at baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: two years after baseline
Naturalistic viewing fMRI at follow-up measurement.
Total score for Strengths and difficulties questionnaire at baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)