Primary objective:investigating whether in a large, representative sample of premature born children (gestational age * 30 weeks and/or birth weight * 1000 gram) with attentional problems in the age of 8 - 12, executing the BrainGame Brian training…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the score on the Strengths and Weaknesses of ADHD
Symptoms and Normal Behavior Rating Scale (SWAN) filled in by parents and
teachers.
Secondary outcome
Secondary outcome measures are the scores on several behavioral questionnaires
filled in by parents and teachers, performance on several neurocognitive tasks
and school performance. See the protocol.
Background summary
In the Netherlands, every year around 2150 children are born very premature
(gestational age * 32 weeks). A large part of these children will encounter
behavioral problems and problems at school when they grow up. Deficiencies in
complex neurocognitive functions, called executive functions, are thought to be
one of the most important undrlieing causes of these problems. Training
executive fucntions is a promising new method to reduce the weak performance in
school and the behavioral problems in this population. A training that has
recently been developed to train executive functions in children, is the
digital computer training BrainGame Brian (BGB).
Study objective
Primary objective:
investigating whether in a large, representative sample of premature born
children (gestational age * 30 weeks and/or birth weight * 1000 gram) with
attentional problems in the age of 8 - 12, executing the BrainGame Brian
training leads to a significant decrease in attentional problems.
Secondary objective:
investigating whether the effect of the BrainGame Brian training also
generalizes to an improvement in school performance (maths and reading
performance).
Study design
The study is a dubbelblind, randomized placebo- and waitlist controlled trial.
Children born very preterm that meet the inclusion criteria (parent reported
attentional problems) are randomized to three groups: an interventiongroup, a
placebogroup and a waitlistgroup. To compare the task and questionnaire
outcomes of the very preterm children with attentional problems to those of
other children, two reference groups are included: a group of very preterm
children without attentional problems and a term control group (both reference
groups will not execute the BrainGame Brian training).
Intervention
In the BrainGame Brian training, the executive functions working memory,
cognitive flexibility and inhibition are trained. The training is adaptive,
which means that the difficulty is adjusted according to the child's
performance. The training consists of 25 sessions of approximately 40 minutes
each. Children will train during a six-week period for four times a week.
Study burden and risks
The BrainGame Brian training is performed four times a week for a six-week
period and is thus quite intensive. Children in the intervention, placebo and
waitlistgroup will travel to the AMC for a pre-training measure and two
post-training measures at which they perform several neuropsychological tests
and parents are asked to fill in several questionnaires. Children in the two
reference groups will travel to the AMC/UMC once following the pre-training
testprotocol. They will not perform the BrainGame Brian training. The research
is not invasive and there are no risks associating with participating in the
study. Advantage of participation is a possible improvement of attentional
problems in the group of very preterm children that performed the BrainGame
Brian training.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
-parent reported attention problems on the Child Behavior Checklist
Exclusion criteria
-IQ scores < 80 as assessed with short form of the Wechsler Intelligence Scale for Children-III-NL (WISC-III-NL; block design and vocabulary subtests)
-motor of perceptual handicap too profound to allow use of a computer
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 | NL54163.018.15 |
OMON | NL-OMON27735 |