- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608333
Efficiency of Early Intervention for Autism Spectrum Disorder (IDEA)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aura
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Bron, Aura, France, 69678 cedex
- Hopital Vinatier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
Other Names:
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Active Comparator: Control group
control group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period
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heteregenous "as usual "community intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental quotient at the Mullen Scale of Early Learning
Time Frame: Change from baseline in developmental quotient at 24 months follow-up
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This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:
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Change from baseline in developmental quotient at 24 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of autism symptoms is measured with ADOS 2
Time Frame: Change from baseline in severity score of autism symptoms at 24 months follow-up
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severity of autism symptoms is measured with ADOS 2 ( Autism Diagnostic observation Schedule 2)
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Change from baseline in severity score of autism symptoms at 24 months follow-up
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Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2
Time Frame: Change from baseline in adaptative behavior at 24 months follow-up
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Adaptative behavior score is measured by the composite score of Vineland adaptative behavior scale 2
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Change from baseline in adaptative behavior at 24 months follow-up
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Productive language level assessed with a standardized French productive language developmental scale
Time Frame: change from baseline in number of words at 24 months follow-up (T2)
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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
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change from baseline in number of words at 24 months follow-up (T2)
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Costs associated with interventions
Time Frame: at 24 months follow-up (T2)
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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
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at 24 months follow-up (T2)
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Developement of communication and symbolic behavior
Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
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Total score of Communication and Symbolic Behaviour Scale Developmental Profil CSBS-DP questionnaire for caregivers (Wetherby et al, 2002)
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At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
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Parent child naturalistic interaction during play
Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
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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
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At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
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Sensorial profil
Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
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Sensorial profil of Dunn
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At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
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Change at the Brief Observation of Social Communication Change (BOSCC)
Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
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The total score of Brief Observation of Social Communication Change
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At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: GEOFFRAY MARIE-MAUDE, DR, CH Le Vinatier
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00124-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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