Actively Recruiting
Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2025-05-01
33
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
Sponsors
I
Istituto per la Ricerca e l'Innovazione Biomedica
Lead Sponsor
I
Istituto Superiore di Sanità
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unimpaired hand use
- Parent agrees to have a caregiver present during all home sessions
- Attendance at all intake sessions
- Permission to videotape evaluations and ESDM treatment
- Italian as one primary language of the parent
- Unimpaired hearing and vision
- Developmental quotient of 35 or higher on the Griffith Scale
- Meets autism spectrum disorder diagnostic criteria through the Autism Diagnostic Observation Schedule (ADOS) with cutoff score of 12 if child produces no words or 10 if child produces some words
You will not qualify if you...
- Serious parental substance abuse
- Parental self-report of bipolar disorder or psychosis
- Known genetic syndromes
- Serious medical conditions such as encephalitis, concussion, or seizure disorder
- Significant sensory impairment
- Birth weight less than 1600 grams and/or gestational age less than 34 weeks
- History of intraventricular hemorrhage
- Known exposure to neurotoxins including alcohol or drugs
- Non-Italian-speaking parents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),
Messina, ME, Italy, 98164
Actively Recruiting
Research Team
L
Liliana Ruta
CONTACT
C
Cristina Carrozza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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