Status:
RECRUITING
Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
Lead Sponsor:
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborating Sponsors:
Istituto Superiore di Sanità
Messina, Italy
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
18-36 years
Phase:
NA
Brief Summary
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 o...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06494605
Start Date
November 1 2021
End Date
May 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),
Messina, ME, Italy, 98164