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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05762133
Eligibility Criteria:
Inclusion Criteria:
* Parents will be 18 years of age or older.
* Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
* Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions
Exclusion Criteria:
The parents will be excluded if:
* There is report of ongoing physical or sexual abuse
* They have plans to terminate the pregnancy
* The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months
Father will be excluded if he:
* Has symptoms of psychosis in the past 12 months
* Has below 6th grade education
* Has difficulty focusing on 1 hour of instruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05762133
Study Brief:
Protocol Section:
NCT05762133