Very Preterm Children With Language Delay and Parent Intervention
Information source: Lille Catholic University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Birth; Language Development; Speech Therapy
Intervention: Parent-implemented intervention (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Lille Catholic University Official(s) and/or principal investigator(s): Amélie Lansiaux, MD, PhD, Study Chair, Affiliation: Groupment des Hôpitaux de l'Institut Catholique de Lille Marie-Laure Charkaluk, MD, PhD, Study Director, Affiliation: Hôpital Saint-Vincent-de-Paul, GHICL
Overall contact: Mélanie Hamez, Med Monitor, Email: hamez.melanie@ghicl.net
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.
Clinical Details
Official title: Parent-implemented Intervention for Very Preterm Children With Language Delay
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: language score of the Developmental Neuropsychological assessment (NEPSY)
Secondary outcome: Other scores of the NEPSY batteryStrengths and Difficulties Questionnaire Parenting Stress Index (PSI) questionnaire
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.
Eligibility
Minimum age: 28 Months.
Maximum age: 32 Months.
Gender(s): Both.
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
Locations and Contacts
Mélanie Hamez, Med Monitor, Email: hamez.melanie@ghicl.net
Centre Hospitalier, Arras 62000, France; Recruiting Amélie Kieffer, MD, Principal Investigator
Centre Hospitalier Universitaire, Caen 14000, France; Recruiting Valérie Datin-Dorrière, MD, Principal Investigator
Centre Hospitalier Universitaire, Lille 59000, France; Recruiting Véronique Pierrat, MD, Principal Investigator
Hôpital Saint Vincent de Paul (GHICL), Lille 59000, France; Recruiting Marie-Laure Charkaluk, MD, PhD, Principal Investigator
Hôpital femme mère enfant, Lyon, France; Not yet recruiting Olivier Claris, MD, Email: olivier.claris@chu-lyon.fr
Centre Hospitalier Universitaire, Marseille, France; Recruiting Catherine Gire, MD, Principal Investigator
Centre Hospitalier Universitaire, Nantes, France; Not yet recruiting Julie Boyer, MD, Principal Investigator
AP-HP Hôpital Antoine Béclère, Paris, France; Not yet recruiting Veronique Zupan, MD
Hôpital Necker, Paris, France; Not yet recruiting Alexandre Lapillonne, MD
HôpitalCochin - Port Royal, Paris, France; Not yet recruiting Saoud Kout, MD
Centre Hospitalier, Roubaix 59100, France; Not yet recruiting Nora Haouari, MD, Principal Investigator
Centre hospitalier Universitaire, Rouen 76000, 76100, France; Not yet recruiting Aude Charollais, MD, Principal Investigator
Centre Hospitalier Universitaire, Strasbourg 67000, France; Recruiting Anne De Saint Martin, MD, Principal Investigator
Centre Hospitalier Universitaire, Tours 37044, France; Not yet recruiting Elie Saliba, MD, Principal Investigator
Centre Hospitalier, Valenciennes 59300, France; Not yet recruiting Fabien Lapeyre, MD, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: May 29, 2015
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