Efficiency of Early Intervention for Autism Spectrum Disorder (IDEA)
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|ClinicalTrials.gov Identifier: NCT02608333|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : January 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: ESDM-12 Behavioral: control group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||September 9, 2015|
|Estimated Primary Completion Date :||March 15, 2021|
|Estimated Study Completion Date :||September 30, 2021|
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.
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 Name: Early Start Denver Model 12 hours per week
Active Comparator: Control group
control group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period
Behavioral: control group
heteregenous "as usual "community intervention
- Developmental quotient at the Mullen Scale of Early Learning [ Time Frame: Change from baseline in developmental quotient at 24 months follow-up ]This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:
- 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 ]severity of autism symptoms is measured with ADOS 2 ( Autism Diagnostic observation Schedule 2)
- 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 ]Adaptative behavior score is measured by the composite score of Vineland adaptative behavior scale 2
- 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) ]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
- Costs associated with interventions [ Time Frame: at 24 months follow-up (T2) ]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
- Developement of communication and symbolic behavior [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up ]Total score of Communication and Symbolic Behaviour Scale Developmental Profil CSBS-DP questionnaire for caregivers (Wetherby et al, 2002)
- 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) ]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
- Sensorial profil [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2) ]Sensorial profil of Dunn
- 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 ]The total score of Brief Observation of Social Communication Change
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608333
|Bron, Aura, France, 69678 cedex|
|Principal Investigator:||GEOFFRAY MARIE-MAUDE, DR||CH LE VINATIER|