NCT06494605Recruiting
Early Neurodivergent Developmental Trajectories in Autism and in Response to the 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
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 1 Nov 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Diseases
- Autism
- NCT number
- NCT06494605
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 1 Nov 2021 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- known exposure to neurotoxins (including alcohol, drugs)
Other illness
- parental self-report of bipolar disorder or psychosis
- known genetic syndromes
- serious medical conditions (e.g., encephalitis, concussion, seizure disorder)
- significant sensory impairment
- history of intraventricular hemorrhage
Age
- birth weight \<1600 grams and/or gestational age \< 34 weeks
Other
- serious parental substance abuse
- non-Italian-speaking parents
Who the study is looking for
- 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)
Age in the registry: 18 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
Related publications
- Early developmental trajectories associated with different styles and intensities of ESDM-based community intervention.J Neurodev Disord · 2026 · PMID 42210093
This page is information, not medical advice. Discuss any trial with your doctor.