Preventing Postpartum Depression in Immigrant Latinas

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Northwestern University
Study ID
NCT05873569
Status
Recruiting
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Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
16 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mothers and Babies Virtual Group Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 15, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Depressive symptoms [ Time Frame: We are examining change in depressive symptoms from baseline to 6-months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21224
Lindsay Cooper, MA
[email protected]
Diane Echavarria, MS
[email protected]

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By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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