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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02850666
Eligibility Criteria:
Inclusion Criteria: Participants with ASD:
* aged 3-4 years old
* documented diagnosis of ASD from a licensed professional using DSM 5 criteria12; If no documentation available, meets cut off on Autism Diagnostic Observation Scale (ADOS -2)13 that will be administered by trained study staff.
* passes language and cognitive screen (see attached screening document with decision rules) and a receptive language age equivalence of ≥18 months and a non-verbal age equivalent score of ≥24 months on the Mullen Scale of Early Learning14
* have a caregiver willing/able to bring them to the University for the study sessions and to schedule up to 3 assessment visits prior to intervention start and 3 assessment sessions after intervention end
* family's primary language is English
Typically developing children
* aged 3-4
* normal or corrected to normal vision and hearing
* English speaking
Exclusion Criteria: Participants with ASD
* have no other major medical conditions (i.e., no genetic disorders such as Fragile X, Down syndrome)
* seizure disorder
* uncorrected hearing or visual impairment
* other condition causing motor impairment, such as Cerebal Palsy
Typically developing children
-no history of developmental delay or neurological disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
4 Years
Study:
NCT02850666
Study Brief:
Protocol Section:
NCT02850666