Very Preterm Children With Language Delay and Parent Intervention

NCT02042235 | Terminated DMC

• 1 other identifier: RC-P0027
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 15

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.

Conditions

Preterm Birth; Language Development; Speech Therapy

Keywords

prematurity; language; parent-implemented intervention; speech therapy; neurodevelopment

Outcome Measures

Primary Outcomes (1)

• language score of the Developmental Neuropsychological assessment (NEPSY)

  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

  at 36 months of corrected age

Secondary Outcomes (3)

• Other scores of the NEPSY battery

  at 36 months of corrected age

• Strengths and Difficulties Questionnaire

  at 36 months of corrected age

• Parenting Stress Index (PSI) questionnaire

  at 36 months of corrected age

Study Arms (2)

Parent-implemented language intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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 …).

Interventions

Parent-implemented intervention 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.

Parent-implemented language intervention

Eligibility Criteria

• Age: 28 Months - 32 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• Ministry of Health, France: collaborator

Study Sites (15)

Centre Hospitalier

Arras, 62000, France

Location

Centre Hospitalier Universitaire

Caen, 14000, France

Location

Centre Hospitalier Universitaire

Lille, 59000, France

Location

Hôpital Saint Vincent de Paul (GHICL)

Lille, 59000, France

Location

Hôpital femme mère enfant

Lyon, France

Location

Centre Hospitalier Universitaire

Marseille, France

Location

Centre Hospitalier Universitaire

Nantes, France

Location

AP-HP Hôpital Antoine Béclère

Paris, France

Location

Hôpital Necker

Paris, France

Location

HôpitalCochin - Port Royal

Paris, France

Location

Centre Hospitalier

Roubaix, 59100, France

Location

Centre hospitalier Universitaire

Rouen, 76000, 76100, France

Location

Centre Hospitalier Universitaire

Strasbourg, 67000, France

Location

Centre Hospitalier Universitaire

Tours, 37044, France

Location

Centre Hospitalier

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Premature Birth; Communication Disorders; Language

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Amélie Lansiaux, MD, PhD

  Groupment des Hôpitaux de l'Institut Catholique de Lille

  STUDY CHAIR

• Marie-Laure Charkaluk, MD, PhD

  Hôpital Saint-Vincent-de-Paul, GHICL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

FR (15)