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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04864808
Eligibility Criteria:
Inclusion Criteria:
\- To be included in the stakeholder group, participants must work at a CNMC primary center or must be a parent with a toddler.
For inclusion to participate in the pilot intervention, a full-time guardian must, at the time of screening:
1. Sign informed consent online
2. Be between 21-55 years old (inclusive) and be English or Spanish-speaking
3. Meet full DSM-5 criteria for ADHD, any subtype as determined by the SCID-5
4. Have current CGI-S-ADHD rating ≥ 4 and \< 7
5. Commit to the entire study
6. Be able to complete all study assessments virtually (i.e., they must have a device that connects to the internet with a camera)
Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent; and (b) if receiving an antidepressant medication, their medication is well-tolerated and has not changed within 30 days.
For inclusion to participate in the pilot intervention, toddlers must:
1. be between ages of 12 - 35 months at time of consent
2. score above the 75th percentile on the BITSEA problem scale
Exclusion Criteria:
* Parents will be excluded on the basis of current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
55 Years
Study:
NCT04864808
Study Brief:
Protocol Section:
NCT04864808