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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03215394
Eligibility Criteria:
Inclusion Criteria:
* The child must be 12-30 months of age with clinically significant signs of ASD (must be under 30 months at study enrollment to be included)
* The toddler and parents must live together, and no more than 50km from the study site
* Child is at home with the caregiver at least 50% of the time (no more than 2.5 days a week in child care, nanny, family care, etc.)
* The child must not be involved in other behavioural interventions, such as ABA/IBI and the Hanen programs, for the duration of the study
* The child may participate in no more than 1 hour per week (monthly average) of the following interventions: speech/language, occupational, and physical therapy, for the duration of the study
* The child's diet and medications have not recently been drastically altered, and are not intended to be altered throughout the study.
* The child does not have other neurological disorders (including epilepsy), genetic syndromes that have known association with ASD (e.g., Fragile X syndrome), significant uncorrected sensory impairments (vision, hearing, etc.), or low birth weight (under 2500g).
* The child is not actively experiencing a regression of skills
* The caregiver is conversant in English and could be coached in English
* The child's eyes are successfully tracked with the eye-tracking technology used throughout the study.
Exclusion Criteria:
* Participant fails to meet any of the above listed Inclusion Criteria.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
30 Months
Study:
NCT03215394
Study Brief:
Protocol Section:
NCT03215394