Clinical trial NCT02042235: Very Preterm Children With Language Delay and Parent Intervention
Official title: Parent-implemented Intervention for Very Preterm Children With Language Delay
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Birth
Language Development
Speech Therapy
Keywords: prematurity
language
parent-implemented intervention
speech therapy
neurodevelopment
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2014-01-22
Enrollment: 67
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 advantages.

Detailed description: 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 appropriate.

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.

Eligibility criteria: Inclusion Criteria:

* Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
* Child aged 30 ± 2 months corrected age (CA) at inclusion
* Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
* Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
* Child whose parents accept participation in this study
* Child with French health insurance coverage

Exclusion Criteria:

* Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ \< 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
* Blindness
* Deafness defined by the prescription of a hearing aid
* Child with a chromosomal or other condition that could interfere with language development
* Parents who do not speak French at all
* Triplets

Primary outcomes:
measure: language score of the Developmental Neuropsychological assessment (NEPSY)
timeFrame: at 36 months of corrected age
Secondary outcomes:
measure: Other scores of the NEPSY battery
timeFrame: at 36 months of corrected age
measure: Strengths and Difficulties Questionnaire
timeFrame: at 36 months of corrected age
measure: Parenting Stress Index (PSI) questionnaire
timeFrame: at 36 months of corrected age
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: Lille
country: France
facility: Centre Hospitalier Universitaire
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul (GHICL)
city: Lyon
country: France
facility: Hôpital femme mère enfant
city: Marseille
country: France
facility: Centre Hospitalier Universitaire
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: Paris
country: France
facility: AP-HP Hôpital Antoine Béclère
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: HôpitalCochin - Port Royal
city: Roubaix
country: France
facility: Centre Hospitalier
city: Rouen
country: France
facility: Centre hospitalier Universitaire
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire
city: Tours
country: France
facility: Centre Hospitalier Universitaire
city: Valenciennes
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Groupment des Hôpitaux de l'Institut Catholique de Lille
name: Amélie Lansiaux, MD, PhD
role: STUDY_CHAIR
affiliation: Hôpital Saint-Vincent-de-Paul, GHICL
name: Marie-Laure Charkaluk, MD, PhD
role: STUDY_DIRECTOR
References: