Tests the Early Start Denver Model in young children with autism
Tests the Early Start Denver Model, a behavioral support, in toddlers with autism.
Plain-language title generated from the registry record
Registry title: Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
Key facts
- Where
- Messina, ItalySee the site
Where in Italy
- Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),Messina, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto per la Ricerca e l'Innovazione Biomedica
- Trial code
- NCT06494605
- Record updated
- 1 May 2025
- Original description
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.Read full original descriptionShow less
Early Neurodivergent Developmental Trajectories in Toddlers and Young Children on the Autism Spectrum and Effectiveness of the Early Start Denver Model in Community Settings
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.
Inclusion: 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: known exposure to neurotoxins (including alcohol, drugs); 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; birth weight <1600 grams and/or gestational age < 34 weeks; serious parental substance abuse; non-Italian-speaking parents.