not applicable not applicable
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 600 children will be recruited from schools and on individual bases to take part in the behavioural testing. A subgroup of 200 children (tested on-site and with participant insurance) will be further recruited to participate in the imaging part of the study at the Donders Institute. 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8.1.1 Main study parameter/endpoint For the behavioural arm: Cognitive task battery on tablet, implemented on the m-Path platform (https://m-path.io/landing/). This battery will measure a series of classic cognitive tasks: working memory, vocabulary, simple reaction time, exploration ability, and fluid reasoning. Each task will yield a set of estimated phenotypic parameters including speed, accuracy, trends, autoregression and variability. Working memory In this task, participants will see a grid of dots. A number of dots will turn white in sequence. The participants are asked to recall the right sequence by selecting each dot in the same order Fluid reasoning Participants will see a 3 by 3 grid, and are asked to select, out of 4 options, which option best fits the blanked out grid. Reaction time Participants will see a grid, where a cartoon mole will appear unpredictably. Their task is to tap the mole as quickly as they can. Vocabulary Participants will see a word, and are asked which of four alternatives best fits the description of the word, or is an antonym (*tegenovergestelde*), to measure their vocabulary. Exploration Participants see a large grid (example from Meder et al., 2021). Under each tile, a *treasure* is hidden of differing values. Participants may select a number of tiles to discover treasure, which is either randomly dispersed (*rough*) or correlated (*smooth*) across the grid, favouring different strategies. For all 5 tasks we will record speed (response time), accuracy (as binary or continuous/press location) and ambient background noise (as decibels, not identifiable sounds). The measurements will entail a *burst* measurement, yielding a week of data on N=600 across all tasks. Fitting a DSEM to this wave of data will yield a rich set of variability estimates. These will be used to generate a completely novel descriptive measure to capture individual differences: The Variability Performance Profile (VPP). Addit | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.1.2 Secondary study parameters/endpoints For the behavioural arm: • Academic results from the child, obtained through the school (e.g., Cito-scores) For the imaging arm: • Cognitive task battery identical to the one used in the behavioural arm, performed by the parent(s) accompanying the child, if parent(s) agrees/signs dedicated informed consent form. 8.1.3 Other study parameters Some demographic measures will be collected to be able to characterise the population and understand our sample, such as sex, SES measures and languages spoken at home. For the behavioural and imaging arm: • Demographic measures of the child (e.g., age, sex, is Dutch the main language at home, education grade/level) | — |
Countries
Netherlands
Contacts
Public ContactR.N.N. Rosalia
Radboud Universitair Medisch Centrum
Outcome results
None listed