Parent-implemented language intervention for very preterm children with language delay. – EPILANG

Very preterm children, born before 32 weeks of gestation, are at risk of impaired neurodevelopment, particularly cognitive deficiency, school difficulties and behaviour troubles. Among these conditions, language difficulties play a crucial role in social interactions and academic performances. As many as 24 to 34 % of very preterm children have poor language abilities between age 2 ½ and age 4. Several studies have shown that parenting factors play an important role in their language difficulties.
In studies of children born at term, early language delay has a spontaneous favourable evolution in 30 to 50 % at the age of 3 years. However, parent-implemented language interventions conducted in the third year of life have already shown a positive effect on language abilities at short term.
Our hypothesis is that such parent-implemented interventions would be particularly appropriate for very preterm children, with a high prevalence of language difficulties associated to parenting factors.
We presently have the opportunity to nest an intervention trial within a large population-based cohort of very preterm children born in France in 2011, the Epipage 2 cohort.
EPILANG is a multicentric randomised controlled intervention trial.
Our aim is to compare a parent-implemented language intervention with the usual “wait and see” attitude for very preterm children with language delay at the corrected age (CA) of 30 months, in order to improve language abilities at short/medium term. Secondary objectives include a better knowledge of language development in very preterm children. Our primary endpoint is language abilities at 42 months CA. Secondary endpoints are child’s global cognition, behaviour and parenting stress at 42 months CA. The Epipage 2 cohort will also make it possible to assess long term benefits from the intervention, namely development and cognition at preschool or school age. Secondary objectives are a better knowledge of language development in very preterm children.
The study population includes children from the Epipage 2 cohort, born before 32 weeks’ gestation, with a language delay at 30 months CA. Exclusion criteria are severe impairment, parents who do not speak French, and triplets. Sample size was calculated 90 children in each group. Children will first be screened using expressive language evaluation by the French Mac Arthur inventory scales – short form (IFDC) at 24 months CA. The sample will be selected on a geographical basis, around the 10 participating centres. Language delay will be defined as a score < - 1 SD using the IFDC at an inclusion visit which will be performed at 30 months CA. Parents will be explained the study and if they agree to participate, the child will be randomised either in a control or an intervention group.
The intervention will be parent-implemented, and parents will be taught how to enhance their child’s language through a structured program, built for the study from the Hanen programs. It follows a highly structured curriculum. Fifteen sessions with the speech therapist, one or both parent(s) and the child are conducted, 12 each week and then 3 each month. The usual “wait and see” attitude is provided to the control group, together with advice to enhance child’s language at home.
Hearing will be verified in children of both groups, according to professional recommendations.
Outcome will be assessed by professionals who will not know if the child was in the intervention or control group. The primary endpoint will be the NEPSY battery – language domain at 42 months CA. Secondary endpoints will be the overall NEPSY assessment of cognitive development, the Strengths and Difficulties Questionnaire, evaluating child behaviour, and the Parenting Stress Index.
With the EPILANG trial, we hope to improve quality of life of very preterm children as well as their families'. We also aim to rationalise costs for care.