Very Preterm Children With Language Delay and Parent Intervention

NCT ID: NCT02042235

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Preterm Birth; Language Development; Speech Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Parent-implemented intervention

Intervention Type: BEHAVIORAL

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.

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 …).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 28 Months
• Maximum Eligible Age: 32 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amélie Lansiaux, MD, PhD

Role: STUDY_CHAIR

Groupment des Hôpitaux de l'Institut Catholique de Lille

Marie-Laure Charkaluk, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Saint-Vincent-de-Paul, GHICL

Locations

Centre Hospitalier

Arras, , France

Centre Hospitalier Universitaire

Caen, , France

Centre Hospitalier Universitaire

Lille, , France

Hôpital Saint Vincent de Paul (GHICL)

Lille, , France

Hôpital femme mère enfant

Lyon, , France

Centre Hospitalier Universitaire

Marseille, , France

Centre Hospitalier Universitaire

Nantes, , France

AP-HP Hôpital Antoine Béclère

Paris, , France

Hôpital Necker

Paris, , France

HôpitalCochin - Port Royal

Paris, , France

Centre Hospitalier

Roubaix, , France

Centre hospitalier Universitaire

Rouen, , France

Centre Hospitalier Universitaire

Strasbourg, , France

Centre Hospitalier Universitaire

Tours, , France

Centre Hospitalier

Valenciennes, , France

Countries

France

Other Identifiers

RC-P0027

Identifier Type: -

Identifier Source: org_study_id