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

NCT06494605 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Early Start Denver Model (ESDM)

The Early Start Denver Model (ESDM) is an early naturalistic and behavioural intervention for children with initial signs of neurodivergence or on the autism spectrum between the ages of 12-48 months. This early intervention aims to increase the rates of development in several domains and to decrease the characteristics of autism conditions that hinder children's ability to learn from everyday experiences and interactions.

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    collaborator OTHER
  • Messina, Italy

    collaborator OTHER
  • Società Cooperativa Sociale AUDACIA

    collaborator UNKNOWN
  • Associazione Ulisse

    collaborator UNKNOWN
  • La Linea Curva

    collaborator UNKNOWN
  • Istituto per la Ricerca e l'Innovazione Biomedica

    lead OTHER

Principal Investigators

  • Liliana Ruta · National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-09-30
Completion
2025-05-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06494605 on ClinicalTrials.gov