Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention

Early support is thought to be key to ensure a better quality of life for young children on the autism spectrum. Among early support, different evidence-based approaches have combined the principles of developmental and behavioral science within a naturalistic and interactive frame and grouped under the umbrella of Naturalistic Developmental Behavioral Interventions (NDBI). In the context of NDBIs, the Early Start Denver Model is a manualized support that has reported evidence of efficacy for therapist-, group- and caregiver-implemented support, in multiple research as well as community based settings, different countries and languages (Rogers \& Dawson, 2010). Understanding the effects of support characteristics and intensity on individual learning has a major impact on the delivery systems organization and policies, sustainability in low resources community settings and to provide the necessary support to the family. However, a direct comparison among different types and intensity of early support in community setting and relatively low access to standardized and intensive programs, have not been adequately explored. For this reason, the aim of this study is to investigate, in a community setting in the Italian context, the impact of ESDM and support intensity on individual developmental trajectories.

NCT Number	NCT06494605
Lead Sponsor	Istituto per la Ricerca e l'Innovazione Biomedica Collaborators: Istituto Superiore di Sanità, Messina, Italy, Società Cooperativa Sociale AUDACIA, Associazione Ulisse, La Linea Curva
Conditions	Autism Spectrum Disorder
Enrollment	33 participants
Start Date	2021-11-01
Primary Completion	2024-09-30 (estimated)
Study Completion	2025-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-01