RecruitingNot ApplicableNCT05873569

Preventing Postpartum Depression in Immigrant Latinas

Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention


Sponsor

Northwestern University

Enrollment

300 participants

Start Date

Oct 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mindfulness-based video game (MB-VG) intervention to prevent postpartum depression in Latina immigrant women, a group that faces higher risk due to cultural, language, and social barriers to mental health care. **You may be eligible if...** - You identify as Latina and speak Spanish - You are at least 16 years old - You are currently pregnant or have a baby under 9 months old - You have some elevated depressive symptoms (but not severe depression) - You have access to a device that can run the video game sessions **You may NOT be eligible if...** - You are experiencing severe depression (scoring above 14 on the Edinburgh Postnatal Depression Scale) - You have active thoughts of suicide or self-harm - You are not pregnant and do not have a baby under 9 months old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALMothers and Babies Virtual Group Intervention

The Mothers and Babies Virtual Group (MBVG) intervention is a 10-session intervention built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and are led by a trained MBVG facilitator.


Locations(1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05873569


Related Trials