Pilot study on the feasibility of a novel computerized cognitive training program to improve executive function in very preterm children

Despite ongoing improvement in perinatal and neonatal care, developmental
outcomes of very preterm birth (gestational age * 30 weeks) remain of
significant concern. Although, severe disabilities occur only in approximately
15% of these children, 50-75% of the very preterm children has mild
disabilities. Such mild disabilities include lower IQ*s (> 1.0SD below term
peers), poor educational achievement, and behavioral problems across childhood.
Very preterm children have a 2.7 fold risk for placement in special education,
a 14.6 fold risk for grade repetition, and most of them require special
educational support at school. Neonatal intervention studies aimed to decrease
these adverse late effects of very preterm birth are urgently needed. The
nationwide follow-up program of very preterm children stops at the age of 5
years. In the subsequent years, parents often ask for help because of
educational and behavioral problems.

Recent studies, including those within our collaboration, have shown that
impaired executive function (EF) underlies very preterm children*s scholastic
and behavioral difficulties. EF refers to interrelated neurocognitive
processes, such as impulse control or working memory, that control thought and
behavior. Poor EF after very preterm birth has been related to disruptions of
white matter circuits connecting frontal, striatal, and thalamic regions.
Remediation of EF skills to delineate the adverse educational and behavioral
outcomes of very preterm birth is a novel and promising opportunity for
intervention. EFs show a long-term development up to young adulthood and are
trainable by adaptive computerized training programs.These studies have
presented behavioral and neurophysiological evidence in children with AD(H)D
that, for instance, working memory capacity can be enhanced by systematic
training and that training effects also yielded significant reduction of
attention problems. Positive effects were maintained at 3 months follow-up.

This pilot study is set up to test the feasibility of the BrainGame Brian
program in a small subsample of very preterm children at 8 to 10 years of age.
Evidence that the program is feasible and differences in EF between
pre-training assessments and post-training assessments will be used to set up a
randomized controlled study.

Ten very preterm children of the former PINO study, please refer to section
3.1, with scores in the (sub)clinical range, i.e. T > 60, on the Behavior
Rating Inventory for Executive Function (BRIEF) and whose parents gave
permission to be approached for participation in future studies will be
invited. An information letter about the study and an informed consent form
will be sent to parents with a request to participate. If parents want to
participate with their child they are asked to return the informed consent form
signed by both parents. If parents do not reply within two weeks then the
researcher will friendly inquire about their participation by telephone.
After return of the informed consent form, parents and children will be phoned
to make the first appointment. During this appointment, a short IQ examination
to derive an estimation of the child*s baseline level of cognitive functioning
and a couple of EF tests will be administered to the child. In addition, the
researcher will explain all aspects of the training to parents and child. Tne
the training phase starts. For the first training session the researcher will
visit parents and the child at home and help them to get started. After 10 and
20 training sessions, the researcher will plan a home visit to get informed
whether parents and child are successfully involved in the training and to
answer any questions.
To perform the training, it will be ensured that parents had a suitable
computer at their disposal. This computer will be placed at a location with
limited distractions. Furthermore, to limit distraction during training,
children will wear headphones, and no contact with the Internet or other
software will be possible on the computer. The post-training assessment will be
conducted between two to four weeks after the training.

BrainGame Brian is an adaptive, computerized training program in which three
EFs, i.e. working memory, inhibition, and cognitive flexibility, are trained
embedded in a game world. The game is called *Braingame Brian,* named after the
main character of the game *Brian.* The training consists of 25 training
sessions and will be performed daily at home for 40 minutes, 4 days for 6
weeks. During the game, the child has to perform training tasks on EF. Each
session contains two blocks (of about 15 min) of the three training tasks of
working memory, inhibition, and cognitive flexibility in a fixed order. The
first training task is a working memory training task, the second an inhibition
training task, and the third a cognitive-flexibility training task. After each
block of training tasks, the difficulty level of the training task is
automatically adjusted to the child*s maximum level of performance. Motivation
is enhanced by elaboration of the game world or extra powers for the game
character Brain. The game world gets more and more elaborate from the first to
the last sessionand every completed block results in extra powers for Brian.
With these extra powers, he can create inventions to help people in his
village, resulting in happier village people.

There is some burden for parents and children since they have to participate in
the program for 4 times a week, for 6 weeks. The training program, however, has
been set up as a computer game and has a very child friendly design. Other
studies conducted on this training program have shown that most children enjoy
to perform the training.
Risk because of participation is negligible.