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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03388294
Eligibility Criteria:
Inclusion Criteria:
* For the intervention trial: infant must meet risk criteria on the First Years Inventory (Calculated based on data collected in another study where risk status on the FYI was confirmed with follow up at 3 years. We empirically determined combinations of the two FYI domain scores that would sort respondents into "at-risk" and "not-at-risk." The resulting cut-points enabled us to sort children such that we capture about 1/3 of those who would go on to be confirmed as having a autism spectrum diagnosis while misclassifying less than 5% of the typically developing (TD) sample as at-risk). Infants also must score at least one s.d. below the mean on either the Receptive or Expressive subscale t scores AND meet the following SPA inclusion criteria on hyporeactivity (HYPO) or hyperreactivity (HYPER):
* "HYPO": Cut-point (equal or greater than) of 1.69 for Mean of the raw orienting score across 7 items, each with the range of 1 to 4 possible points)
* "HYPER": Cut-point (equal or greater than) of .333 for Mean of the raw approach/avoid novel toys score across 9 items, each with the range of 0 to 2 possible points) OR Any clear "defensive" response on orienting items or "Yes" to covering ears to sound (in stereotypies checklist)
Exclusion Criteria:
* families who speak English \< 50% of the time at home
* infants with previously identified genetic disorders (e.g., Down syndrome)
* infants with identified vision/hearing/physical impairments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Months
Maximum Age:
16 Months
Study:
NCT03388294
Study Brief:
Protocol Section:
NCT03388294