Efficiency of Early Intervention for Autism Spectrum Disorder (IDEA)

Hôpital le Vinatier

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: ESDM-12; Behavioral: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02608333

2015-A00124-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 15 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

ESDM-12

Experimental group

Description:

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.

Treatment:

Behavioral: ESDM-12

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: control group