Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06494605
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
36 Months
Study:
NCT06494605
Study Brief:
Protocol Section:
NCT06494605