Early intervention for speech sound disorder in very preterm or very low birth weight children: a randomized controlled trial.

In the Netherlands about 2% to 3% of children are born very preterm (VP/VLBW;
i.e. gestational age <32 weeks or birth weight <1500grams). Deficits in speech
sound development and prereading skills (<10th centile) are three to five times
more frequent in this group; 24% of VP/VLBW children has not normalized speech
by age 6.1,2 Currently, treatment for a speech sound disorder (SSD) starts
after 3 years of age. This speech therapy is to some extent effective,
however, it takes quite a long time (approximately 25% of all children with
diagnosed SDD has not yet normalised speech at age 6), and the children often
develop significant frustration or behavioral difficulties as a result of not
being understood by their environment. Language problems at age three already
can have an impact on children's social life.3 Research has shown that VP/VLBW
children have significantly lower Health Related Quality of Life than the
reference group in the scales for lungs, stomach, eating disorders, motor
functioning, communication, and anxiety.4 Hille et al found that at the age of
9 years, 19% of VP/VLBW children were in special education compared to 4.7% in
the general population. Of the VP/VLBW children in mainstream education, 32%
were in a grade below the appropriate level for age and 38% had special
assistance.5 Therefore, it is clinically and societally relevant to investigate
the efficacy of parent based intervention for VP/VLBW children with SDD as
early as possible, at a very young age. Parent based early intervention for
language disorders6 and for stuttering7 have been shown to be effective. We
assume that such very early, parent based intervention can result in a higher
percentage of recovered VP/VLBW children at school-age.

The primary objective of this study is to examine the effectiveness of a short,
highly structured parent based speech intervention programme on speech
development in VP/VLBW children with speech sound disorder (SSD) at 2 years of
age.

A single-center randomized controlled trial (RCT) with blinded outcome
assessment.

The parent based early intervention is based on an interactive model of speech
intervention, which presumes that optimized parental input will provide better
speech learning opportunities. In the intervention, the primary caregiver of
the VP/VLBW child will be taught to catch the attention of the child and to
introduce child-oriented, communicative interaction promoting behaviors, like
mirroring what the child *says*, expanding oral-motor behavior, babbling and
sound production by the child, reading nursery rimes and sharing picture books,
using a slow-normal, clear and expressive articulation. The parent will be
taught to positively reinforce relevant behaviors.

Burden:
1. Determination of speech sound developmental outcome requires three hospital
visits (1 hour per visit) at the age of 2, 2* and 3 years of age.

2. Parent based early intervention consists of seven sessions of about 60
minutes within three months. The primary caregiver will be invited to receive
the treatment in the Erasmus MC-Sophia. However, for the children who live in
Zeeland or Brabant who don*t want to participate because of the substantial
travel distance between their home and the hospital, it will be possible to
have the intervention at one of two peripheral speech clinics. The intervention
will be given by two certified speech and language pathologists, one in Zeeland
and one in Brabant.

3. For determination of Preschool Quality Of Life parent(s) of the treated and
no-treated VP/VLBW children are asked to fill out one questionnaire at 2 and 3
years of age (CHQ-IT97); 15 minutes) and a Visual Analogue Scale for
health-related quality of life (VAS; 1 minute) and two standardized pateint
reported outcome scales about the satisfaction of the parents about
communication of their child in everyday speaking situations and judgement of
its intelligibility (ICS) (5 minutes). Just after treatment the primary
caregiver will be asked to fill out a treatment evaluation form (10 minutes).

4. Determination of hearing function during the hospital visit at 3 years of
age (20-25 minutes).

5. Determination of the Peabody Picture Vocabulary Score of the parent during
the hospital visit at 3 years of age (15 minutes).

Benefit and risks:
The intervention group will receive speech treatment, of which in literature
and clinical practice no risks are known. The short, highly structured parent
based speech intervention programme can lead to better speech developmental
outcome. The no-intervention group will only be assessed at 2, 2* and 3 years
of age. The parents of the children in the non-treatment group are offered the
choice to have the usual care in a peripheral speech clinic in the home
environment by the time their child is three years old. Randomization is
tenable because, until now, the usual care for SSD is speech treatment for
children who are at least 3 years of age.

Group relatedness:
VP/VLBW children are vulnerable in their development and are at risk for school
and behavior problems, which persist into young adulthood.8 Even with no major
neurosensory impairment, approximately 20-40% of VP/VLBW children develop
speech and languages problems, with speech development being more affected than
language development.1 24% of VP/VLBW children has no normal speech by age 6.1
Therefore, studies on the effects of parent based early intervention for SSD
will have to be performed in these children.