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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07471594
Eligibility Criteria:
The following is a list of inclusion and exclusion criteria by participant group across all three research aims.
Inclusion Criteria for All Participants:
* Able to provide written and informed consent;
* Both sexes and all racial and ethnic origins;
* English fluency (necessary for informed consent and measure completion)
Inclusion Criteria for Providers:
* Is between 18 and 75 years of age
* Holds a contract with or formally employed by BabyNet
* Provides services within BabyNet at least one half-hour per week
* Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Exclusion Criteria for Providers:
* Not contracted or employed by BabyNet
* Provides services less than one half-hour per week
* Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)
Inclusion Criteria for Caregiver in Caregiver-Child Dyad:
* Is between 18 and 75 years of age
* Is the legal guardian of the participating child
* Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services
Exclusion Criteria for Caregiver in Caregiver-Child Dyad:
* Not between 18 and 75 years of age
* Not the legal guardian of the child
* Not able to be present for BabyNet services
Inclusion Criteria for Children in Caregiver-Child Dyad:
* Is between 12 and 36 months of age
* Is enrolled in BabyNet services at least one half-hour per week
* Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
* Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Exclusion Criteria for Children in Caregiver-Child Dyad:
* Is not between 12 and 36 months of age
* Is not receiving services in BabyNet at least one half-hour per week
* Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
* Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
36 Months
Study:
NCT07471594
Study Brief:
Protocol Section:
NCT07471594