Efficiency of Early Intervention for Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

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.
    

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.
    

Intervention name(s): ESDM-12; control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; heteregenous "as usual "community intervention
Other intervention name(s): Early Start Denver Model 12 hours per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early intervention; ESDM; behavioral and developmental intervention