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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Lille Catholic University
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT02042235
First received: January 20, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 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 Intervention
Preterm Birth
Language Development
Speech Therapy
Behavioral: Parent-implemented intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Parent-implemented Intervention for Very Preterm Children With Language Delay

Resource links provided by NLM:


Further study details as provided by Lille Catholic University:

Primary Outcome Measures:
  • language score of the Developmental Neuropsychological assessment (NEPSY) [ Time Frame: at 36 mois of corrected age ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 36 month of corrected age ] [ Designated as safety issue: No ]
    To evaluate the child's neuropsychological functioning

  • Strengths and Difficulties Questionnaire [ Time Frame: at 36 month of corrected age ] [ Designated as safety issue: No ]
  • Parenting Stress Index (PSI) questionnaire [ Time Frame: at 36 month of corrected age ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 …).

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.

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

Ages Eligible for Study:   28 Months to 32 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child born at 24 to 31+6 weeks' gestation, participating in the EPIPAGE 2 cohort, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042235

Contacts
Contact: Magalie Demilly, Med Monitor +33 3 20 22 57 00 demilly.magalie@ghicl.net
Contact: Gabriela Certad, MD, PhD +33 3 20 22 57 35 certad.gabriela@ghicl.net

Locations
France
Centre Hospitalier Not yet recruiting
Arras, France, 62000
Principal Investigator: Amélie Kieffer, MD         
Centre Hospitalier Universitaire Not yet recruiting
Brest, France, 29200
Principal Investigator: Jacques Sizun, MD         
Centre Hospitalier Universitaire Not yet recruiting
Caen, France, 14000
Principal Investigator: Valérie Datin-Dorrière, MD         
Centre Hospitalier Universitaire Not yet recruiting
Lille, France, 59000
Principal Investigator: Véronique Pierrat, MD         
Hôpital Saint Vincent de Paul (GHICL) Not yet recruiting
Lille, France, 59000
Principal Investigator: Marie-Laure Charkaluk, MD, PhD         
Centre Hospitalier Universitaire Not yet recruiting
Marseille, France
Principal Investigator: Catherine Gire, MD         
Centre Hospitalier Universitaire Not yet recruiting
Nantes, France
Principal Investigator: Julie Boyer, MD         
Centre Hospitalier Not yet recruiting
Roubaix, France, 59100
Principal Investigator: Nora Haouari, MD         
Centre hospitalier Universitaire Not yet recruiting
Rouen, France, 76000, 76100
Principal Investigator: Aude Charollais, MD         
Centre Hospitalier Universitaire Not yet recruiting
Strasbourg, France, 67000
Principal Investigator: Anne De Saint Martin, MD         
Centre Hospitalier Not yet recruiting
Valenciennes, France, 59300
Principal Investigator: Fabien Lapeyre, MD         
Sponsors and Collaborators
Lille Catholic University
Ministry of Health, France
Investigators
Study Chair: Elisabeth Baumelou, MD Groupment des Hôpitaux de l'Institut Catholique de Lille
Study Director: Marie-Laure Charkaluk, MD, PhD Hôpital Saint-Vincent-de-Paul, GHICL
  More Information

No publications provided

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02042235     History of Changes
Other Study ID Numbers: RC-P0027
Study First Received: January 20, 2014
Last Updated: January 22, 2014
Health Authority: France: Ministry of Health

Keywords provided by Lille Catholic University:
prematurity
language
parent-implemented intervention
speech therapy
neurodevelopment

Additional relevant MeSH terms:
Communication Disorders
Language Development Disorders
Premature Birth
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Language Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 20, 2014