Impact of the ESDM on the development of children with ASD in a European French-speaking population: First results of the intervention implementation

Abstract

Introduction Early intervention for autism spectrum disorder (ASD) in the European French-speaking countries is heterogeneous and poorly evaluated to date. Early intervention units applying the Early Start Denver Model (ESDM) for toddlers and young children with ASD have been created in France and Belgium to improve this situation. It is essential to evaluate this intervention for the political decision-making process regarding ASD interventions in European French-speaking countries. We selected the implementation of a 12-hour ESDM intervention for children with ASD over a 2-year period as part of the IDEA trial. This ESDM intervention can be complex to implement. It is subject to many organizational constraints. It relies on a strong involvement of both ESDM professional teams and parents to implement this individual intervention adapted to each child. It is therefore important at this stage of the IDEA study to evaluate the ESDM intervention implementation. Methods The IDEA trial is an ongoing multicentre, randomised controlled trial, using a two-stage Zelen design. Children included are aged 15 to 36 months, diagnosed with ASD and with a Developmental Quotient (DQ) of 30 or above on the Mullen Scale of Early Learning (MSEL). We use a stratified minimisation randomisation at a ratio 1:2 in favour of the control group. The sample size requires is 180 children (120 in the control and 60 in the intervention group). The intervention evaluated is a 12-hour per week ESDM by trained therapists (10 hours in the centre and 2 hours in the toddlers’ natural environment). The control group receives care available in the community. Our aim was to evaluate the ESDM intervention implementation for children in the intervention group, by evaluating the number of sessions and the number of hours ESDM conducted and analyzing reasons for absence and organization of centers. Results To date, 131 children have been included: 88 randomized children in the control group, 43 randomized in the intervention group. At inclusion, children’ characteristics in the intervention group were mean age 29.8 months, the level of behavioral change and severity of autistic symptoms at ADOS score of 7.6 (max score 10.0) and developmental quotient at Mullen score of 45.9 (max score 59.1). ESDM intervention sessions were completed for 65% of the children. Seventy-five percent of the reasons for cancellation were related to the organization of ESDM professional teams (holidays, training/absences of professionals). The average number of intervention hours delivered was of 8 hours per week. The average number of hours delivered increased (from 6.6 hours to 9.6 hours per week) during the months of ESDM intervention implementation, suggesting a gradual implementation. Conclusions The evaluation of the intervention implementation showed that children received on average 4 hours less ESDM intervention than initially planned by the protocol. The reasons for canceling sessions related to families are limited (25%), which shows a strong motivation and involvement on their part. The results highlight the factors limiting the ESDM intervention implementation (necessary adaptation period, organizational constraints of the professional teams).