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

RecruitingNAAges 18 Months - 36 MonthsAllIstituto per la Ricerca e l'Innovazione Biomedica
NCT06494605 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Early Start Denver Model (ESDM)
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Where

1 site
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),
Messina, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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