The current study aims to establish a database containing control data of TD children on a range of relevant domains for clinical neuroscientific research, including data on demographics, medical history, as well as neurophysiological, behavioural,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde ontwikkeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No primary end-point is defined for this study. Background characteristics
involve demographics and medical history. Relevant outcome domains studied here
involve neurophysiological, neurocognitive, behavioral and academic
functioning.
- Demographics and medical history will be collected using a custom
questionnaire developed by the Emma Neuroscience Group.
- Behavioural functioning of children and youth will be assessed using the
extended version of the Strengths and Difficulties Questionnaire (SDQ) (Van
Widenfelt, Goedhart, Treffers & Goodman, 2003). Besides the SDQ, the Strengths
and Weaknesses of ADHD symptoms and Normal behaviour scale (SWAN; Swanson et
al., 2012) will be used to assess behavioural functioning.
- Cognitive functioning will be assessed using a version of the Wechsler
Intelligence Scale (depending on the participants age) (Wechsler, 2002;
Wechsler, 2005; Wechsler, 2008).
- Neurocognitive functions will be assessed using the Emma Toolbox for
Computerized Neurocognitive Testing. The Emma Toolbox is an in-house designed
battery of computerized tests, presented as games, that assesses
neurocognitive domains (e.g. information processing, attention, learning &
memory, and visuomotor integration).
- Brain activity will be measured using EEG, a non-invasive and widely used
tool to assess the E-I balance.
- School performance: CITO Pupil Monitoring System results will be used to
assess school performance.
Secondary outcome
not applicable
Background summary
Control data of typically developing (TD) children is required to investigate
the nature and manifestation of pediatric conditions. At present every
pediatric population of interest is compared to a newly recruited control
group. This inefficient way of working may be served by formation of a database
including control data on a wide range of domains that will act as a universal
control group in future pediatric projects. Such a database may also allow
studying relations between different domains of functioning in TD children and
to better understand their manifestation in clinical populations.
Study objective
The current study aims to establish a database containing control data of TD
children on a range of relevant domains for clinical neuroscientific research,
including data on demographics, medical history, as well as
neurophysiological, behavioural, neurocognitive and academic functioning. The
database can be used as a universal control group in future studies in the
field of pediatric neuroscience. In addition, we aim to study the relations
between different domains of functioning in TD children across development to
better understand the relationship between the studied domains of functioning.
Study design
Observational study.
Study burden and risks
Participation in this study consists of one test session, with an estimated
duration of 3 hours. The test session consists of (parent and child rated)
questionnaires, electroencephalogram (EEG) assessment and neurocognitive
assessment. Dependent on the explicit informed consent from the legal
guardian(s), pupil monitoring system (CITO) data will be collected as a measure
of academic performance. The resulting database will function as a universal
control group in future paediatric projects. Currently identified projects are
on pediatrics who experienced Traumatic Brain Injury and children that are
diagnosed with Autism Spectrum Disorder. Such projects will be presented for
ethical review separately. The control database is necessary to elucidate the
impact of specified disorders on the identified outcome measures, as corrected
for a range of background variables (e.g. demographics and medical history).
Standardized population norms are available for some of the outcome measures,
but these norms are only standardized for age and/or sex, while it is
well-known that other demographic characteristics can have a considerable
influence on paediatric functioning (i.e. socio-economic status). The
confounding influence of the complex interplay between numerous variables needs
to be taken into account for valid and reliable research in paediatric
cohorts. By creating this control database we will reduce the burden for
multiple future projects that require a control group, hence minimizing the
total burden exercised by our research on TD children and their parents.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. 4-18 years old;
2. Fluent Dutch speaker;
3. Inhabitant of the Netherlands.
Exclusion criteria
1. Absence or withdrawal of written informed consent;
2. Severe motor disability that interferes with outcome assessment;
3. Inability to comprehend testing instructions.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76915.018.21 |
| OMON | NL-OMON25801 |