COgnitive Dynamics in Early Childhood

Официальное название

Cognitive Dynamics in Early Childhood

Обзор

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?

Первичные конечные точки

• Reaction times from the vocabulary cognitive task [Срок оценки: Through study completion, an average of 3 years]
• Reaction times from the exploration cognitive task [Срок оценки: Through study completion, an average of 3 years]
• Reaction times from the Working Memory cognitive task [Срок оценки: Through study completion, an average of 3 years]
• Reaction times from the speed cognitive task [Срок оценки: Through study completion, an average of 3 years]
• Reaction times from the fluid reasoning cognitive task [Срок оценки: Through study completion, an average of 3 years]
• Mood score on smiley slider [Срок оценки: Through study completion, an average of 3 years]
• Sleep score on smiley slider [Срок оценки: Through study completion, an average of 3 years]
• MP-RAGE MRI sequence baseline [Срок оценки: an average of 1 year]
• Functional MRI sequence of low time constraint reasoning task at baseline [Срок оценки: an average of 1 year]
• gaze direction during reasoning task at baseline [Срок оценки: an average of 1 year]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Radboudumc Department of Cognitive Neuroscience — Nijmegen

Публикации

• 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

Идентификаторы

NCT: NCT06330090 · NL84688.091.23 · 101040534

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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