EPILANG: Very Preterm Children With Language Delay and Parent Intervention

Sponsor

Lille Catholic University (Other)

Overall Status

Terminated

CT.gov ID

NCT02042235

Collaborator

Ministry of Health, France (Other)

Enrollment

Locations

Arms

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Language Development Speech Therapy	Behavioral: Parent-implemented intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Parent-implemented Intervention for Very Preterm Children With Language Delay

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Jan 31, 2018

Arms and Interventions

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 …).

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 …).

Outcome Measures

Primary Outcome Measures

language score of the Developmental Neuropsychological assessment (NEPSY) [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

Secondary Outcome Measures

Other scores of the NEPSY battery [at 36 months of corrected age]
To evaluate the child's neuropsychological functioning
Strengths and Difficulties Questionnaire [at 36 months of corrected age]
Parenting Stress Index (PSI) questionnaire [at 36 months of corrected age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Months to 32 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier	Arras	France	62000
2	Centre Hospitalier Universitaire	Caen	France	14000
3	Centre Hospitalier Universitaire	Lille	France	59000
4	Hôpital Saint Vincent de Paul (GHICL)	Lille	France	59000
5	Hôpital femme mère enfant	Lyon	France
6	Centre Hospitalier Universitaire	Marseille	France
7	Centre Hospitalier Universitaire	Nantes	France
8	AP-HP Hôpital Antoine Béclère	Paris	France
9	Hôpital Necker	Paris	France
10	HôpitalCochin - Port Royal	Paris	France
11	Centre Hospitalier	Roubaix	France	59100
12	Centre hospitalier Universitaire	Rouen	France	76000, 76100
13	Centre Hospitalier Universitaire	Strasbourg	France	67000
14	Centre Hospitalier Universitaire	Tours	France	37044
15	Centre Hospitalier	Valenciennes	France	59300

Sponsors and Collaborators

Lille Catholic University
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