Very Preterm Children With Language Delay and Parent Intervention
Parent-implemented Intervention for Very Preterm Children With Language Delay
In studies of children born at term, language delay at the age of 2 years exhibits a
spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no
recommendation for speech therapy before the age of 3 years. However, for term-born
children, parent-implemented language interventions conducted during the third year of life
have already shown a positive short-term effect on language skills. In these interventions,
a skilled interventionist, generally a speech therapist, teaches parents how to use specific
language strategies with their child.
The investigators' hypothesis is that such parent-implemented interventions would be
particularly appropriate at short and medium term for the improvement of linguistic
performances in very preterm children, a population with a high prevalence of early language
delay. Currently, there is an opportunity to partly nest an intervention trial in a national
prospective population-based cohort of very preterm children, the EPIPAGE (Etude
EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies
born alive in France in 2011. This situation provides considerable methodological
EPILANG is an open randomized controlled study, in which the final assessment of the
children (endpoint) will be conducted by professionals blinded to the treatment group.
Some eligible children will first be screened using the parental questionnaire at 24 months
corrected age (CA) of the EPIPAGE 2 cohort. Children with language delay, defined as no
words combination and/or less than 30 words from Mac Arthur CDI - short version, and free of
exclusion criteria, will be invited to an inclusion visit at 30 months CA, if they are in an
EPIPAGE 2 centre participating in the EPILANG trial.
During the inclusion visit, inclusion criteria and the absence of exclusion criteria will be
checked, data useful for the study will be collected, and the informed consent of the
parents collected. The child will then be randomized either in the control or the
intervention group if language delay is still present, defined by a score < 10th percentile
at the Mac Arthur CDI. Twins, if both included, will be included in the same group,
otherwise only the twin with a language delay will be randomized.
The intervention is organized in 15 weekly one-hour sessions with the child, one or both
parents and a speech therapist recruited and trained for the study. Maximum duration for the
intervention will be 6 months per child, because some sessions can be missed or delayed.
Parents' participation will be recorded.
The usual "wait-and-see" attitude will be provided to the control group, together with basic
advice to enhance the child's language at home.
In both groups, audition will be checked by an otolaryngology specialist, following
professional recommendations, and care will be provided in case of hearing deficit, if
At 3 years CA, a neuropsychological evaluation will be performed by trained psychologists
for both groups, blinded for the allocation group. Behaviour will be evaluated with a
validated parental questionnaire.
The analysis will be according to intention to treat.
Preterm Birth, Language Development, Speech Therapy
prematurity, language, parent-implemented intervention, speech therapy, neurodevelopment
Lille Catholic University
Lille Catholic University, Ministry of Health, France