Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
View:

• 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.

Locations
United States
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Darius Tandon, PhD
dtandon@northwestern.edu
410-852-0399
Backup
Lindsay Cooper, MA
lcoope45@jhmi.edu
Time Frame
Start Date: 2023-10-15
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 300
Treatments
Experimental: Mothers and Babies Virtual Group Intervention
Women randomized to the Mothers and Babies Virtual Group (MBVG) arm will receive the 10 session MBVG intervention. Sessions are delivered weekly or bi-weekly via Zoom, making 20 weeks the longest possible MB-VG cohort. Sessions were designed to last 60 minutes, with an additional 15 minutes for sessions including a Resource Advocate or pediatrician. Prior to the first session, a member of the research team will test Zoom connections with each participant. All MB-VG groups will be delivered in Spanish by a trained MB-VG facilitator, with a study team member available to provide tech support as needed. MB-VG sessions will be delivered in chronological order.
No_intervention: Usual Family Support Services
Women randomized to the usual family support services arm will receive family support services from the early childhood center in which they are enrolled but no MB-VG intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Johns Hopkins University, Palo Alto University
Leads: Northwestern University

This content was sourced from clinicaltrials.gov