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Mothers and Babies Virtual Group Intervention / Postpartum Depression · Interventional Study
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Type 1 Effectiveness-Implementation RCT registering a virtual group cognitive-behavioral intervention (Mothers and Babies Virtual Group) to prevent postpartum depression in pregnant and postpartum immigrant Latinas at elevated risk. The trial is active and enrollment complete, but no results have been posted to this registry record; the study cannot yet inform clinical practice.
Interventional, Randomized, Parallel, Open label, Prevention purpose. Postpartum Depression; Female; age from 16 Years; accepts healthy volunteers. Intervention: Mothers and Babies Virtual Group Intervention. Compared with: Usual Family Support Services — No Intervention. n = 300. 1 site: United States.
This is a planned Type 1 Effectiveness-Implementation RCT registering a virtual group cognitive-behavioral intervention (Mothers and Babies Virtual Group) to prevent postpartum depression in pregnant and postpartum immigrant Latinas at elevated risk. The trial is active and enrollment complete, but no results have been posted to this registry record; the study cannot yet inform clinical practice.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a registry record of an active, ongoing randomized controlled trial with no published results; the design is sound but the evidence base is absent until completion and outcome reporting.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05873569). This is a study registration, not published results. Lead sponsor: Northwestern University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Postpartum Depression. Interventions: BEHAVIORAL: Mothers and Babies Virtual Group Intervention. Primary outcome measures: Depressive symptoms , We are examining change in depressive symptoms from baseline to 6-months post-intervention; Depressive episodes , We are examining new cases of depressive episodes at 3- and 6-months post-intervention; Parenting self-efficacy , We will examine parenting self-efficacy at 3- and 6-months post-intervention; Parenting responsiveness , We will examine parenting responsiveness at 3- and 6-months post-intervention. 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.
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