Understanding early development in autism and the effects of ESDM intervention
Early Neurodivergent Developmental Trajectories in Toddlers and Young Children on the Autism Spectrum and Effectiveness of the Early Start Denver Model in Community Settings
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Months to 36 Months |
| Sex | All |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica Academic / other |
| Locations | 1 site (Messina, ME) |
| Trial ID | NCT06494605 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown success with similar interventions, particularly the Early Start Denver Model, indicating a promising approach to early autism support.
Eligibility criteria
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 this trial is running
Messina, ME
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.