Very Preterm Children With Language Delay and Parent Intervention (EPILANG)

March 2, 2020 updated by: Lille Catholic University

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 advantages.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France, 62000
        • Centre Hospitalier
      • Caen, France, 14000
        • Centre Hospitalier Universitaire
      • Lille, France, 59000
        • Hôpital Saint Vincent de Paul (GHICL)
      • Lille, France, 59000
        • Centre Hospitalier Universitaire
      • Lyon, France
        • Hôpital Femme Mère Enfant
      • Marseille, France
        • Centre Hospitalier Universitaire
      • Nantes, France
        • Centre Hospitalier Universitaire
      • Paris, France
        • Hopital Necker
      • Paris, France
        • AP-HP Hôpital Antoine Beclere
      • Paris, France
        • HôpitalCochin - Port Royal
      • Roubaix, France, 59100
        • Centre Hospitalier
      • Rouen, France, 76000, 76100
        • Centre Hospitalier Universitaire
      • Strasbourg, France, 67000
        • Centre Hospitalier Universitaire
      • Tours, France, 37044
        • Centre Hospitalier Universitaire
      • Valenciennes, France, 59300
        • Centre Hospitalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent-implemented language intervention
In the intervention group, the techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
Behavioral: Parent-implemented intervention
In order to achieve the programme of parent-implemented language intervention, a detailed protocol for speech therapists recruited and trained for the present study has been established. The techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
No Intervention: Control group
The control group will benefit from the actual routine care for children with language delay before the age of 3 years. In order to provide them the best routine care, the psychologist will provide some advice to the parents to enhance their child's language (e.g.: using life situations to talk with the child and encourage him/her to talk …).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
language score of the Developmental Neuropsychological assessment (NEPSY)
Time Frame: at 36 months of corrected age
For the main outcome, mean language score on the NEPSY at the final visit, our primary endpoint, will be compared between groups using linear regression
at 36 months of corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other scores of the NEPSY battery
Time Frame: at 36 months of corrected age
To evaluate the child's neuropsychological functioning
at 36 months of corrected age
Strengths and Difficulties Questionnaire
Time Frame: at 36 months of corrected age
at 36 months of corrected age
Parenting Stress Index (PSI) questionnaire
Time Frame: at 36 months of corrected age
at 36 months of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Amélie Lansiaux, MD, PhD, Groupment des Hôpitaux de l'Institut Catholique de Lille
  • Study Director: Marie-Laure Charkaluk, MD, PhD, Hôpital Saint-Vincent-de-Paul, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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