Understanding early development in autism and the effects of ESDM intervention
Official title: Early Neurodivergent Developmental Trajectories in Toddlers and Young Children on the Autism Spectrum and Effectiveness of the Early Start Denver Model in Community Settings
Run by Istituto per la Ricerca e l'Innovazione Biomedica · NCT06494605 · Data updated 2026-11-12
This study is testing how the Early Start Denver Model (ESDM) can help young children with autism develop better and whether different types of support make a difference in their learning.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 36 Months |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica Academic / other |
| Locations | 1 site (Messina, ME) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | September 30, 2024 |
| Study ends | May 31, 2025 |
| Registry record updated | May 1, 2025 |
| Trial ID | NCT06494605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are young children diagnosed with Autism Spectrum Disorder who meet specific developmental criteria and have Italian-speaking parents.
✕Probably not a fit
Patients with serious medical conditions, significant sensory impairments, or those whose parents do not speak Italian may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on the early developmental trajectories of children with Autism Spectrum Disorder (ASD) and evaluates the impact of the Early Start Denver Model (ESDM) intervention. It aims to assess how different characteristics and intensities of support influence individual learning outcomes in young children on the autism spectrum. The study will involve caregiver participation and the use of video recordings to analyze treatment effectiveness. By examining these factors, the research seeks to inform better delivery systems and support for families in various community settings.
Why it matters
Potential benefit: If successful, this study could enhance early intervention strategies for children with autism, leading to improved developmental outcomes.
How similar studies have gone: Previous studies have shown success with similar interventions, particularly the Early Start Denver Model, indicating a promising approach to early autism support.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * unimpaired hand use * parent agreement 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 all of these autism spectrum disorder diagnostic criteria through the Autism Diagnostic Observation Schedule (ADOS; cutoff score of 12 if child produces no words or 10 if child produces some words) Exclusion Criteria: * serious parental substance abuse * parental self-report of bipolar disorder or psychosis * known genetic syndromes * serious medical conditions (e.g., encephalitis, concussion, seizure disorder) * significant sensory impairment * birth weight \<1600 grams and/or gestational age \< 34 weeks * history of intraventricular hemorrhage * known exposure to neurotoxins (including alcohol, drugs) * non-Italian-speaking parents
Where it's running
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Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),
Messina, Me, Italy Recruiting
Study contacts
- Principal investigator: Liliana Ruta — National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)
- Study coordinator: Liliana Ruta
- Email: liliana.ruta@irib.cnr.it
- Phone: 3387638295
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.