NCT05873569 · Northwestern University
Preventing Postpartum Depression in Immigrant Latinas
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Mothers and Babies Virtual Group Intervention
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.
Primary outcome measures
Depressive symptoms
Time frame: We are examining change in depressive symptoms from baseline to 6-months post-intervention
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.
Depressive episodes
Time frame: We are examining new cases of depressive episodes at 3- and 6-months post-intervention
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.
Parenting self-efficacy
Time frame: We will examine parenting self-efficacy at 3- and 6-months post-intervention
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.
Parenting responsiveness
Time frame: We will examine parenting responsiveness at 3- and 6-months post-intervention
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Baltimore, Maryland
Collaborators
Johns Hopkins University, Palo Alto University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations