Efficiency of Early Intervention for Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Early Intervention on the Global Development of Children With Autism Spectrum Disorder in a European French-speaking Population Dr Marie-Maude GEOFFRAY Le Vinatier Hospital

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: ESDM-12
* Behavioral: control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESDM-12<br>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<br>* 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.<br>* Other names: Early Start Denver Model 12 hours per week;|
| Active Comparator: Control group<br>control group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period | Behavioral: control group<br>* heteregenous as usual community intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of autism symptoms is measured with ADOS 2 | severity of autism symptoms is measured with ADOS 2 ( Autism Diagnostic observation Schedule 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 | Adaptative 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 | This criterion will be assessed with a standardized French productive language developmental scale (DLPF Development du language de production in French language) filled by parents | change from baseline in number of words at 24 months follow-up (T2) | 
| Costs associated with interventions | Healthcare, social and personal resources devoted to child care throughout the study will be measured to evaluate the direct and indirect costs associated with intervention. Assessment will take place | at 24 months follow-up (T2) | 
| Developement of communication and symbolic behavior | Total score of Communication and Symbolic Behaviour Scale Developmental Profil CSBS-DP questionnaire for caregivers (Wetherby et al, 2002) | At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up | 
| Parent child naturalistic interaction during play | Dyadic Communication Measure for Autism (DCMA)(Green et al, 2010; Pickles, 2015) will be used and score of parent's communication synchrony, child initiation, and shared attention will be assessed | At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2) | 
| Sensorial profil | Sensorial profil of Dunn | At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2) | 
| Change at the Brief Observation of Social Communication Change (BOSCC) | The total score of Brief Observation of Social Communication Change | At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early intervention, ESDM, behavioral and developmental intervention