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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05635760
Eligibility Criteria:
Inclusion Criteria:
* Have a confirmed diagnosis of autism spectrum disorder or was evaluated to have elevated likelihood ("at-risk" or "suspected") by a Clinical Psychologist, Psychiatrist or Pediatrician who recommended continuous surveillance.
* Meet ADOS-2 criteria for autism or autism spectrum.
* Limited spontaneous expressive language, defined as producing two-to-three-word phrases or fewer, i.e., Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Module 2, Item A1 \> 0.
Exclusion Criteria:
* Mullen Scale of Early Learning non-verbal age at or less than 12 months
* Parent who has severe psychological or neurological conditions prohibiting them from conducting the intervention program at home (restricted to only the parent in the program)
* Children with any other severe developmental problems beyond autism spectrum disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
60 Months
Study:
NCT05635760
Study Brief:
Protocol Section:
NCT05635760