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| Name | Class |
|---|---|
| Istituto Superiore di Sanità | OTHER |
| Messina, Italy | OTHER |
| Società Cooperativa Sociale AUDACIA | UNKNOWN |
| Associazione Ulisse |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental study | Experimental | The experimental group consists of 33 children diagnosed with early signs of neurodivergence or diagnosis of autism. The sample is aged between 18 and 48 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Start Denver Model (ESDM) | Behavioral | The Early Start Denver Model (ESDM) is an early naturalistic and behavioural intervention for children with initial signs of neurodivergence or on the autism spectrum between the ages of 12-48 months. This early intervention aims to increase the rates of development in several domains and to decrease the characteristics of autism conditions that hinder children's ability to learn from everyday experiences and interactions. |
| Measure | Description | Time Frame |
|---|---|---|
| The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) | The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) is the "gold standard" for the assessment of autism spectrum disorder. It is an activity-based assessment evaluating communication skills, social interaction and imaginative use of materials through five modules:
Autism Spectrum: total score ≥ 8 Autism: total score ≥ 12
| The test will be scheduled pre intervention (T0) after six months (T2) and at the study conclusion, 1 year (T4). The complete test takes 90 minutes. |
| Griffith Scale Development Scales (GMDS) | The Griffith Mental Development Scales (GMDS-ER) assess the developmental quotient of infants and young children from birth to eight years in five developmental areas (Griffith, 2006):
| The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete test takes 90 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liliana Ruta | Contact | 3387638295 | liliana.ruta@irib.cnr.it | |
| Cristina Carrozza | Contact | 3462241627 | cristina.carrozza@irib.cnr.it |
| Name | Affiliation | Role |
|---|---|---|
| Liliana Ruta | National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), | Recruiting | Messina | ME | 98164 | Italy |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| UNKNOWN |
| La Linea Curva | UNKNOWN |
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|
| Vineland Adaptive Behavior Scales (VABS) |
The Vineland Adaptive Behavior Scales (VABS) is a standardized assessment tool and measure adaptive behavior (Sparrow et al., 2005). It uses standard scores, percentile ranks and v-scale scores to evaluate an individual's performance across different domains: Communication, Daily Living Skills, Socialization, Motor Skills (optional), and Maladaptive Behavior (optional). The key metrics include:
The scores are norm-referenced, meaning they compare an individual's performance to a representative sample of the population, with an average (mean) score of 100 and a standard deviation of 15 for the ABC and domain scores. |
| The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete test takes 60 minutes. |
| Early Start Denver Model Curriculum | The Early Start Denver Model Curriculum Checklist for Young Children with Autism is used to provide a comprehensive assessment of the skills of toddlers and preschoolers with autism spectrum disorder across a range of developmental domains and to set individualized instructional goals. Administered every 12 weeks, it is an essential tool in the intervention program outlined in Early Start Denver Model for Young Children with Autism manual. | The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete curriculum takes 90 minutes. |
| Derived |
| Ruta L, Leonardi E, Carrozza C, Fama FI, Campisi A, Aiello S; NEST Team; Marino F, Ruggieri A, Baieli S, Mangiapane D, Vivona G, Marciante S, Cusimano G, Narzisi A, Muratori F, Gagliano A, Colombi C, Tartarisco G, Mastrogiuseppe M, Rogers SJ, Lombardo MV, Pioggia G. Early developmental trajectories associated with different styles and intensities of ESDM-based community intervention. J Neurodev Disord. 2026 May 29. doi: 10.1186/s11689-026-09698-w. Online ahead of print. |