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NCT05873569 · ClinicalTrials.gov registry record · NA

Preventing Postpartum Depression in Immigrant Latinas

A NA study of Postpartum Depression, sponsored by Northwestern University.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
1
Study location

NCT05873569 is a NA study of Postpartum Depression that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 300 participants, below the 527-participant average among 38 other Postpartum Depression trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05873569, a NA study of Postpartum Depression, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
1
Study location

Study 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

Conditions Studied

Interventions

  • BEHAVIORAL Mothers and Babies Virtual Group Intervention

Study Locations (1)

Maryland

  • Johns Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-10-15
Est. Completion 2027-04-30
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT05873569

The ClinicalTrials.gov registry entry for NCT05873569 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 527-participant average among 38 other Postpartum Depression trials with a reported enrollment target (43% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention - of which Mothers and Babies Virtual Group Intervention is the first listed.

NCT05873569 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05873569 about?

NCT05873569 is a clinical study titled "Preventing Postpartum Depression in Immigrant Latinas". 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 ...

What is the current status of trial NCT05873569?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-10-15. Estimated completion is 2027-04-30.

What conditions does trial NCT05873569 study?

This clinical trial studies the following conditions: Postpartum Depression.

What interventions are being tested in trial NCT05873569?

The interventions under investigation include: Mothers and Babies Virtual Group Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT05873569?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05873569 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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