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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03536351
Eligibility Criteria:
Inclusion Criteria: for children 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 ≥30 months and a non-verbal age equivalent score of ≥30 months on the Mullen Scale of Early Learning
* 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
INCLUSION for TD children:
* aged 3-4
* normal or corrected to normal vision and hearing
* English speaking
Exclusion Criteria: for children 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 Cerebral Palsy
Exclusion for TD children:
* history of developmental delay or neurological disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
4 Years
Study:
NCT03536351
Study Brief:
Protocol Section:
NCT03536351