The primary objective of the pilot study is to optimise the design of the large cohort study and test the logistics and course of measurement. Furthermore, the pilot study allows us to assess and adapt the burden of the measurements for the children…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Psychosociale ontwikkeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main evaluation criteria for the pilot study are: The number of measures
failed due to baby*s fatigue or loss of attention; the observed and registered
burden of the testing for the babies and children; the self-reported burden for
the parents; total workload for the measurement team and feasiblity of the
planning and the day scripts; costs and efficiency of the recruitment procedure
and resulting response rates.
Secondary outcome
Efficiency of two conditions of measurement for the baby cohort; data
reliability obtained in the two conditions of measurement; preference of
parents for measurement location.
Background summary
The large Utrecht CID study will provide information on the interaction between
environmental and biological determinants on children*s behaviour, and the role
of brain development in the development of a child*s behaviour. The study will
thus shed new light on why some children thrive and others do not. Preceding
the design of the two large cohorts of the CID Utrecht study, a pilot study is
proposed. The pilot study is meant to give an empirical basis for the specific
design questions that the study is facing and to optimise the logistics and
course of measurement.
Study objective
The primary objective of the pilot study is to optimise the design of the large
cohort study and test the logistics and course of measurement. Furthermore, the
pilot study allows us to assess and adapt the burden of the measurements for
the children and parents. Secondary objectives are the comparison of baby
measures taken at home with measures taken at the research center; and the
estimation of the short-term reliability of the EEG measurements in babies.
Study design
Pilot study for observational longitudinal cohort study. Measures of brain
activity are recorded during the presentation of social stimuli and the
execution of attentional tasks, using EEG registration and MRI scanning. In
addition, cognitive tests and behavioural tasks are carried out. A split-ballot
design is used to compare baby measures taken at home with measures taken at
the research center.
Study burden and risks
Since the focus of the Utrecht CID cohort study is on brain development from
birth into adolescence, the general cohort study can only be performed in
children: young babies as well as pre-adolescents. To be truly predictive for
the main study, the pilot study needs to be performed in the same age groups.
Children and parents have no direct personal benefit from the study. There are
no known risks associated with participation in the proposed research and the
burden is estimated to be low (a total course of 1,5 days, with an effective
measurement time of about 90 minutes to 2,5 hours).
Heidelberglaan 1
Utrecht 3584CS
NL
Heidelberglaan 1
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
Babies: 9-11 month old
Adolescents: between 9 years 11 months and 10 years 1 month old
Exclusion criteria
- Premature born (<32 weeks gestational age)
- Children with a congenital disease
- For the 10 year old children: the standard list of exclusion criteria for MRI (irrremovable metal objects, etc.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48126.041.14 |