COgnitive Dynamics in Early Childhood

Official title

Cognitive Dynamics in Early Childhood

Overview

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?

Primary outcome measures

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

Secondary outcome measures (6)

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Netherlands · 1 center

• Radboudumc Department of Cognitive Neuroscience — Nijmegen

Publications

• 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

Identifiers

NCT: NCT06330090 · NL84688.091.23 · 101040534

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗