Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Early Start Denver Model (ESDM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06494605

CNR-IRIB-PRO-2024-010

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Experimental study

Experimental group

Description:

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

Treatment:

Behavioral: Early Start Denver Model (ESDM)