Efficiency of Early Intervention for Autism Spectrum Disorder

NCT02608333 | Completed

• 1 other identifier: 2015-A00124-45
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Early intervention; ESDM; behavioral and developmental intervention

Outcome Measures

Primary Outcomes (1)

• Developmental quotient at the Mullen Scale of Early Learning

  This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:

  Change from baseline in developmental quotient at 24 months follow-up

Secondary Outcomes (8)

• Severity of autism symptoms is measured with ADOS 2

  Change from baseline in severity score of autism symptoms at 24 months follow-up

• Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2

  Change from baseline in adaptative behavior at 24 months follow-up

• Productive language level assessed with a standardized French productive language developmental scale

  change from baseline in number of words at 24 months follow-up (T2)

• Costs associated with interventions

  at 24 months follow-up (T2)

• Developement of communication and symbolic behavior

  At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up

Study Arms (2)

ESDM-12

EXPERIMENTAL

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.

Behavioral: ESDM-12

Control group

ACTIVE COMPARATOR

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

Behavioral: control group

Interventions

ESDM-12 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.

Also known as: Early Start Denver Model 12 hours per week

ESDM-12

control group BEHAVIORAL

heteregenous "as usual "community intervention

Control group

Eligibility Criteria

• Age: 15 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• University Hospital, Strasbourg, France: collaborator
• Versailles Hospital: collaborator
• Centre hospitalier Saint Jean de Dieu - ARHM: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Hopital Vinatier

Bron, AURA, 69678 cedex, France

Location

Related Publications (2)

• 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.

  PMID: 40473417 DERIVED

• 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.

  PMID: 28348195 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• GEOFFRAY MARIE-MAUDE, DR

  CH LE VINATIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: November 18, 2015
• Study Start: September 9, 2015
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)