NCT05873569 Preventing Postpartum Depression in Immigrant Latinas
| NCT ID | NCT05873569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-10-15 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-10-15 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.
Eligibility Criteria
Inclusion Criteria: * Self-identify as Latina * Speak Spanish * Be at least 16 years old * Be pregnant or have a child \<9 months * Have access to a device they can use for MB-VG sessions. * Elevated depressive symptoms either scores of 5-14 on the Edinburgh Postnatal Depression Scale (EPDS) and/or scores 3.5 or greater prenatally or 4.5 or greater prenatally on the Postpartum Depression Predictors Inventory. Exclusion Criteria: * Individuals who score \>14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus. * Individuals not at risk for PPD-i.e., EPDS scores \<5 and under the PDPI-R cutoff-will also be excluded.
Contact & Investigator
Darius Tandon, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05873569 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05873569 currently recruiting?
Yes, NCT05873569 is actively recruiting participants. Contact the research team at dtandon@northwestern.edu for enrollment information.
Where is the NCT05873569 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05873569 clinical trial?
NCT05873569 is sponsored by Northwestern University. The principal investigator is Darius Tandon, PhD at Northwestern University. The trial plans to enroll 300 participants.
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