Impact du modèle Early Start Denver sur le niveau cognitif des enfants avec un diagnostic de trouble du spectre de l'autisme: protocole d'étude pour un essai randomisé contrôlé utilisant un modèle Zelen à deux étapes

Aperçu: G.M.

L'intervention précoce pour le trouble du spectre de l'autisme (TSA) dans les pays francophones d'Europe est hétérogène et mal évaluée à ce jour. Les unités d'intervention précoce appliquant le modèle Early Start Denver (ESDM) pour les tout-petits et les jeunes enfants avec un diagnostic de TSA ont été créées en France et en Belgique pour améliorer cette situation.

Nous évaluerons l'efficacité de 12 heures par semaine d'intervention ESDM sur le niveau cognitif des enfants avec un diagnostic de TSA, sur une période de 2 ans. 

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BMJ Open. 2017 Mar 27;7(3):e014730. doi: 10.1136/bmjopen-2016-014730.

Impact of the Early Start Denver Model on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design

Touzet S^1,2, Occelli P^1,2, Schröder C^3,4, Manificat S⁵, Gicquel L^6,7, Stanciu R⁸, Schaer M⁹, Oreve MJ¹⁰, Speranza M^10,11, Denis A^1,2, Zelmar A^1,2, Falissard B^12,13, Georgieff N^14,15, Bahrami S^11,16, Geoffray MM^14,15; IDEA Study Group.

Collaborators (30)

Grisi S, Marignier S, Useo JM, Pourrat A, Peter C, Mengarelli F, Gallifet N, Rumillat F, Tenant G, Sonié S, Zimmerman M, Malo V, Jacob CG, Bahrami S, Queste C, Raffeneau F, Gilet S, Ammeloot M, Danion-Grilliat A, Florence E, Vecchionacci V, Janssen L, Dubrovskaya A, Rohmer M, Lambs B, Delvenne V, Carlier S, Ducenne L, Colin C, Bouveret L.

Author information

1

Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon F-69003, France.

2

Laboratoire Health Services and Performance Research, EA 7425 HESPER, Université de Lyon, Lyon F-69008 France.

3

Department of Child and Adolescent Psychiatry, Hopitaux universitaires de Strasbourg, Strasbourg F-67000, France.

4

CNRS UPR 3212-Team 9, Strasbourg University, Strasbourg F-67000, France.

5

Centre Hospitalier Saint Jean de Dieu, Lyon F-69008, France.

6

Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Spécialisé Henri Laborit, Saint Benoît F-86280, France.

7

Child and Adolescent Psychiatry Department, Unité de Recherche Clinique, Université de Poitiers, Poitiers F-86000, France.

8

Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, Bruxelles 1020, Belgium.

9

Office Médico-Pédagogique, University of Geneva, Geneva, Switzerland.

10

Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier de Versailles, Le Chesnay F-78150, France.

11

EA 4047 HANDIReSP, Université de Versailles Saint-Quentin-en-Yvelines, Versailles F-78000, France.

12

Université Paris-Sud, CESP, INSERM, UVSQ, Université Paris-Saclay, U1178, Maison de Solenn, Paris cedex 14, France.

13

Department of Public Health, AP-HP, Hôpital Paul Brousse, Villejuif F-94800, France.

14

Department of child and adolescent psychiatry, Centre Hospitalier le Vinatiers, Bron F-69500, France.

15

Université de Lyon, Lyon F-69008, France.

16

CIC 1429, INSERM, AP-HP, Hôpital Raymond-Poincare, Garches F-92380, France.

Abstract

INTRODUCTION:

Early intervention for autism spectrum disorder (ASD) in the European French-speaking countries is heterogeneous and poorly evaluated to date. Early intervention units applying the Early Start Denver Model (ESDM) for toddlers and young children with ASD have been created in France and Belgium to improve this situation. It is essential to evaluate this intervention for the political decision-making process regarding ASD interventions in European French-speaking countries. We will evaluate the effectiveness of 12 hours per week ESDM intervention on the cognitive level of children with ASD, over a 2-year period.

METHODS AND ANALYSIS:

The study will be a multicentre, randomised controlled trial, using a two-stage Zelen design. Children aged 15-36 months, diagnosed with ASD and with a developmental quotient (DQ) of 30 or above on the Mullen Scale of Early Learning (MSEL) will be included. We will use a stratified minimisation randomisation at a ratio 1:2 in favour of the control group. The sample size required is 180 children (120 in the control and 60 in the intervention group). The experimental group will receive 12 hours per week ESDM by trained therapists 10 hours per week in the centre and 2 hours in the toddlers' natural environment (alternatively by the therapist and the parent). The control group will receive care available in the community. The primary outcome will be the change in cognitive level measured with the DQ of the MSEL scored at 2 years. Secondary outcomes will include change in autism symptoms, behavioural adaptation, communicative and productive language level, sensory profile and parents' quality of life. The primary analysis will use the intention-to-treat principle. An economic evaluation will be performed.

DISSEMINATION:

Findings from the study will be disseminated through peer reviewed publications and meetings.

TRIAL REGISTRATION NUMBER:

NCT02608333 (clinicaltrials.gov); Pre-results.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

PMID: 28348195

DOI: 10.1136/bmjopen-2016-014730