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Efficiency of Early Intervention for Autism Spectrum Disorder

NCT02608333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-07-09

No results posted yet for this study

Summary

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.

Conditions

Interventions

BEHAVIORAL

ESDM-12

ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010). Children receive ESDM 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

BEHAVIORAL

control group

heteregenous "as usual "community intervention

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • Versailles Hospital

    collaborator OTHER

  • Centre hospitalier Saint Jean de Dieu - ARHM

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Hôpital le Vinatier

    lead OTHER

Principal Investigators

  • GEOFFRAY MARIE-MAUDE, DR · CH LE VINATIER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-09
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608333 on ClinicalTrials.gov