Preventing Postpartum Depression in Immigrant Latinas

NCT05873569 | Recruiting DMC

• 1 other identifier: STU00217105
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Depressive symptoms

  Depressive symptoms will be measured using the Center for Epidemiologic Studies-Depression (CES-D) scale. The CES-D consists of 20 questions that map onto DSM criteria for depression, with higher scores indicating greater depressive symptoms. The range for the CES-D is 0-60.

  We are examining change in depressive symptoms from baseline to 6-months post-intervention

• Depressive episodes

  Depressive episodes will be measured using the Mood Disorders module of the Structured Clinical Interview for DSM-V (SCID-5), a semi-structured interview for DSM-V Axis 1 diagnoses. The presence of a depressive episode is ascertained by scoring responses to the SCID questions, with major depression diagnosis ascribed to individuals who endorse: (a) 5 or more depressive symptoms for ≥ 2 weeks, (b) Must have either depressed mood or loss of interest/pleasure, (c) Symptoms must cause significant distress or impairment, and (d) No manic or hypomanic behavior.

  We are examining new cases of depressive episodes at 3- and 6-months post-intervention

• Parenting self-efficacy

  Parenting self-efficacy will be measured using the self-efficacy subscale of the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS). The subscale has 7 items, with higher scores indicating greater parental self-efficacy. Calculate the mean score for each subscale. Scores range from 0-10.

  We will examine parenting self-efficacy at 3- and 6-months post-intervention

• Parenting responsiveness

  Parenting responsiveness will be measured using the parental responsiveness subscale of the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS). The subscale has 7 items, with higher scores indicating greater parental responsiveness. Calculate the mean score for each subscale. Scores range from 0-10.

  We will examine parenting responsiveness at 3- and 6-months post-intervention

Secondary Outcomes (6)

• Behavioral activation

  We will examine change in behavioral activation between baseline and 6-month post-intervention follow-up

• Decentering

  We will examine change in decentering between baseline and 6-month post-intervention follow-up

• Social support

  We will examine change in social support between baseline and 6-month post-intervention follow-up

• Mood management

  We will examine change in mood management between baseline and 6-month post-intervention follow-up

• Anxiety symptoms

  We will examine change in anxiety symptoms between baseline and 6-month post-intervention follow-up

Study Arms (2)

Mothers and Babies Virtual Group Intervention

EXPERIMENTAL

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.

Behavioral: Mothers and Babies Virtual Group Intervention

Usual Family Support Services

NO INTERVENTION

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.

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.

Mothers and Babies Virtual Group Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals who score \>14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus.
• Individuals not at risk for PPD-i.e., EPDS scores \<5 and under the PDPI-R cutoff-will also be excluded.

Sponsors & Collaborators

• Northwestern University: lead
• Johns Hopkins University: collaborator
• Palo Alto University: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (1)

• Platt R, Polk S, Barrera AZ, Lara-Cinisomo S, Hirschhorn LR, Graham AK, Musci RJ, Hamil J, Echavarria D, Cooper L, Tandon SD. Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial. Trials. 2024 Sep 11;25(1):606. doi: 10.1186/s13063-024-08423-z.

  PMID: 39261967 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Darius Tandon, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Rheanna Platt, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darius Tandon, PhD

CONTACT

410-852-0399; dtandon@northwestern.edu

Lindsay Cooper, MA

CONTACT

lcoope45@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: October 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the conclusion of the study. Data will be available in perpetuity.
• Access Criteria: Researchers interested in examining intervention effects associated with this study, or interested in conducting descriptive analysis of the sample will be granted permission to IPD. Decisions on release of data will be made by the study MPIs and study biostatistician.

Locations

US (1)