Efficiency of Early Intervention for Autism Spectrum Disorder

NCT ID: NCT02608333

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-09
• Study Completion Date: 2021-06-30

Brief 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.

Detailed Description

This is a multicenter (4 centers in France, 1 center in Switzerland and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 18 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. After diagnostic, Children will be included in a longitudinal cohort with the consent of the parents. Sixty children will be drawn lots among 180 children of the cohort and will be included in a ESDM intervention with the consent of the parents. Two groups will be compared: an experimental group of 60 children receiving 12 hours a week of ESDM intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. Global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the Mullen Scale of Early Learning (MSEL), the ADOS-2 and the Vineland Adaptive Behavior Scale. Cost of each intervention will be calculated.

The primary outcome is global development of the child, measured by the developmental quotient with the Mullen after 24 months of intervention.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESDM-12

ESDM -12 : 60 children will receive 12 hours a week of ESDM ( Early Start Denver Model)intervention delivered by trained therapists during 2 years.ESDM is a comprehensive relational, developmental and behavioral intervention.It's described in a manual for Professional and parents.

Group Type: EXPERIMENTAL

ESDM-12

Intervention Type: BEHAVIORAL

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.

Control group

control group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: BEHAVIORAL

heteregenous "as usual "community intervention

Interventions

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.

Intervention Type: BEHAVIORAL

control group

heteregenous "as usual "community intervention

Intervention Type: BEHAVIORAL

Other Intervention Names

Early Start Denver Model 12 hours per week

Eligibility Criteria

Inclusion Criteria

• Children 15 months to 36 months
• Children with autism spectrum disorder (according to international criteria and standardized tests)
• Children at a DQ of 30 at least at the MSEL
• Family domiciled within 40 minutes of a early intervention unit (investigator center for the study)

Exclusion Criteria

• Severe neurological or physical disorder identified not allowing intensive care
• Unavailability of the family for regular monitoring of the child by the investigator center
• Rett Syndrom

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: collaborator

Versailles Hospital

OTHER

Sponsor Role: collaborator

Centre hospitalier Saint Jean de Dieu - ARHM

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GEOFFRAY MARIE-MAUDE, DR

Role: PRINCIPAL_INVESTIGATOR

CH LE VINATIER

Locations

Hopital Vinatier

Bron, AURA, France

Countries

France

References

Geoffray MM, Oreve MJ, Jurek L, Sonie S, Schroder C, Delvenne V, Manificat S, Touzet S, Agathe J, Mengarelli F, Natacha G, Petit N, Speranza M, Bahrami S, Bouveret L, Dochez SL, Auphan P, Zelmar A, Falissard B, Carlier S, Nourredine M, Denis A, Febvey-Combes O. Early Start Denver Model effectiveness in young autistic children: a large multicentric randomised controlled trial in two European countries. BMJ Ment Health. 2025 Jun 5;28(1):e301424. doi: 10.1136/bmjment-2024-301424.

Reference Type: DERIVED

PMID: 40473417 (View on PubMed)

Touzet S, Occelli P, Schroder C, Manificat S, Gicquel L, Stanciu R, Schaer M, Oreve MJ, Speranza M, Denis A, Zelmar A, Falissard B, Georgieff N, Bahrami S, Geoffray MM; IDEA Study Group. 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. BMJ Open. 2017 Mar 27;7(3):e014730. doi: 10.1136/bmjopen-2016-014730.

Reference Type: DERIVED

PMID: 28348195 (View on PubMed)

Other Identifiers

2015-A00124-45

Identifier Type: -

Identifier Source: org_study_id