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Very Preterm Children With Language Delay and Parent Intervention

NCT02042235 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-03-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Amélie Lansiaux, MD, PhD · Groupment des Hôpitaux de l'Institut Catholique de Lille

  • Marie-Laure Charkaluk, MD, PhD · Hôpital Saint-Vincent-de-Paul, GHICL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Months
Max Age
32 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042235 on ClinicalTrials.gov