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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02409303
Eligibility Criteria:
Inclusion Criteria:
PCPs:
-PCPs must work at a participating primary care practice.
EI Providers:
-EI providers must work at a participating early intervention agency.
Caregivers and Toddlers:
To be categorized as part of the ASD Concerns Sample recruited from PCP offices:
* Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; or (4) screening positive for ASD on a validated screening tool.
* Toddlers must be between 16-20 months of age
To be categorized as part of the No ASD Concerns Sample recruited from PCP offices:
\- Toddlers must be between 16-20 months of age
To be categorized as part of the ASD Dx/ASD Concerns Sample recruited from EI agencies:
* Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; (4) screening positive for ASD on a validated screening tool; or (5) parent-report of an ASD diagnosis.
* Toddlers must be between 16-30 months of age
Exclusion Criteria:
-There are no exclusion criteria for PCPs or EI providers.
Caregivers/toddlers meeting the inclusion criteria described above will be excluded if the caregiver:
-reports that the toddler has any severe visual, auditory, or physical impairments, and/or serious medical, genetic, or neurological disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Months
Study:
NCT02409303
Study Brief:
Protocol Section:
NCT02409303