Development and evaluation of the feasibility of an ageappropriate additional, preventive intervention for very preterm children at 18 months.

Very preterm born children are vulnerable and have a significantly higher risk
for developmental problems. The Infant Behavioral Assessment and Intervention
Program (IBAIP), an early preventive intervention, given at home until 6 months
of corrected age (CA), had a positive effect on the motor, mental, and
behavioural development of very preterm children at 6 months CA. At 24 and 44
months, we still found a positive effect on motor development, but not on
behavioural and mental development anymore. Recent literature suggests that the
behavioural and mental development of children might improve optimally if the
intervention coincides with the sensitive periods for these developmental
domains. Taking advantage of this sensitive period, by facilitating
developmental-appropriate learning situations, is a unique opportunity to
stimulate development, and thus prevent developmental problems at a later age.

Primary Objective:
To develop and evaluate the feasibility of an additional, preventive
intervention at 18 months CA for very preterm children and their parents who
received the ToP programme.

Secondary Objective(s):
1. To evaluate the parental satisfaction of the additional intervention.
2. To obtain information on the effect size of the additional intervention on
mental, language, and behavioural development in very preterm children compared
to very preterm children who received only the ToP programme.

Endpoints of the study are (1) there is an additional, preventive intervention
to support parents in the development of their very preterm child at 18 months
CA, and the intervention can be applied to parents from diverse cultural
backgrounds, (2) parents are satisfied with the additional intervention, (3)
information is available for power calculations to evaluate the effect of the
additional intervention in a randomized controlled trial.

Design: The pilot study design is a non-randomized controlled trial, with a
pre-post test design.

The additional intervention will follow the same steps and approaches of the
ToP rogramme, but will be implemented during play and daily activities suitable
for children from approximately 18 to 22 months CA. Parents will be encouraged
to positively engage in practical activities with their child, comprising free
play, shared book reading, and daily activities as eating and dressing. In line
with the ToP programme, the behaviour of the child is analysed and interpreted
as follows: 1) When the child shows stabile, information seeking behaviour,
parents are encouraged to enjoy their child*s autonomy or positively engage in
practical activities with their child, adding associating language or small
developmental steps; 2) When the child shows self-regulatory efforts to
concentrate, cope, or console, parents are encouraged to give verbal, visual,
or physical support to their child*s own self-regulating strategies; or parents
may adapt the environment when their child*s efforts are at the cost of their
energy and protect their child from interference when engaged in a focused
activity; 3) When the child shows signs of disorganization or non-engagement,
parents are encouraged to adapt the timing, intensity or complexity of the
environmental information to protect their child from stress, or to provide the
child*s internal needs to recover from disbalance (e.g. sleep or food).
An evidence-based intervention program that, similar to the IBAIP, involves a
responsive parenting style, specifically targeting communication, is the Hanen
programme (www.hanen.org). The Hanen programme, based on the transactional
model of development, assumes that increased parental responsiveness in
communication interactions leads to children who are more active in
interactions and in turn increase the diversity of their vocabulary (22). The
(pre)speech therapist from the EOP, certified in both the IBAIP and the Hanen
programme, will incorporate elements of these programmes in the training for
the paediatric physical therapists who implement the additional intervention.
The additional intervention will also take place at home, and will be carried
out by the same interventionist who provided the ToP programme, which will
enhance the feasibility of the programme. Similar to the ToP programme, after
each session a written report will be made for the parents, including a summary
of the findings, strength-based recommendations, and photo*s. The amount of
home visits will depend on the individual needs of the child and parent, and
vary between 4-6 sessions.

Burden: All parents of the children fill in three questionnaires at 18 and 24
months CA. During the regular appointment at the Couveuze Nazorg Poli, the
BSID-III will be administered (this is already standard care in the VUMC for
all very preterm born children and in the AMC for children with a birth weight
< 1000 g or gestational age < 30 weeks). In addition, a videotaped observation
of a parent-child interaction will be performed, of approximately 10 minutes.
Benefits: we hypothesize that the additional intervention has a positive effect
on the cognitive, language and behavioural development of the very preterm
children.
Risks: the risk for children in this study is negligible.