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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT06935461
Eligibility Criteria:
Inclusion Criteria:
* Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:
1. have confirmed PAE as ascertained by the standard child development center intake procedures;
2. and 2) qualify for IDEA Part C EI services based on presence of a developmental delay (\>25% in one or more areas of development) or therapist/provider informed clinical opinion.
Caregiver inclusion criteria:
1. biological, foster, adoptive, or other legal guardian;
2. age 18 or older;
3. any gender.
Exclusion Criteria:
* Child exclusion criteria:
1. child has lived with current caregiver for less than 30% of chronological age or there is a planned change in caregiver placement or move out of King County within 3 months of intake;
2. child has a medical or congenital/genetic condition that would severely limit participation in assessments, such as a significant visual or hearing impairment, degenerative muscle condition, or uncontrolled seizures;
3. multiple birth;
4. child currently receives inpatient medical care (e.g., NICU) or has a medical condition requiring a planned inpatient hospitalization or surgical intervention (e.g., heart condition);
5. child diagnosis of a known genetic or non-FASD neurodevelopmental condition (e.g., Down syndrome, autism spectrum disorder).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT06935461
Study Brief:
Protocol Section:
NCT06935461