Clinical trial NCT05873569: Preventing Postpartum Depression in Immigrant Latinas
Official title: Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Palo Alto University
First posted: 2023-05-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Postpartum depression (PPD)-i.e., depression in the first postnatal year-affects 10-20% of women and is associated with diminished functioning, impaired interpersonal relationships, decreased parenting self-efficacy and less responsive parenting. Immigrant Latinas living in the United States are disproportionately affected by PPD, with rates estimated between 30-42%. Hypothesized mechanisms for this excess risk include acculturative stress, high rates of trauma, poverty, discrimination, and limited social support. Unfortunately, PPD prevention and treatment is limited among immigrant Latinas due to structural and cultural factors including lack of insurance, competing demands, shortages of language-concordant providers, and stigma. These factors underscore not only the need for interventions to reach this population, but also the need to deliver interventions outside of traditional healthcare settings.

Mothers and Babies (MB) is a group-based cognitive-behavioral intervention designed to teach mood regulation skills to women at risk for PPD. Originally developed for women of Latin American descent, the United States Preventive Services Task Force recognized MB as one of the two most effective counseling interventions for PPD prevention, with moderate to large effects sizes found across a series of randomized controlled trials (RCTs). MB has shown consistent positive effects when delivered to women across different racial/ethnic groups, including immigrant Latinas. However, prior MB trials with immigrant Latinas have found variability in dosage received, resulting in weaker intervention effects for individuals less fully engaging with the intervention. Previous MB trials also did not explicitly address social determinants of health such as food insecurity that may mitigate intervention effects. Immigrant Latinas have found the group modality highly effective in decreasing isolation and expanding access to resources and social networks, thus suggesting a potential larger role for group intervention modalities to address key social determinants of health.

This R01 application builds on previous trials of the MB in-person group intervention with immigrant Latinas by examining the effectiveness and implementation of virtual delivery of MB ("Mothers and Babies Virtual Group"; MB-VG). No prior studies have examined the effectiveness of a virtual group-based intervention to prevent PPD. Virtual interventions have the potential to mitigate structural barriers to receipt of mental health services commonly experienced by immigrant Latinas, thereby enabling increased intervention dosage. Virtual platforms can also facilitate delivery of multidisciplinary content by off-site providers that address inter-related social determinants of health that may moderate intervention impact. As such, the Investigators developed and pilot-tested MB-VG, modifying content of the in-person MB group intervention for virtual delivery, incorporating content focused on social determinants of health and parenting delivered by external service providers, and incorporating text messages as an implementation strategy to reinforce intervention content and promote intervention engagement. Pilot testing with 30 immigrant Latinas enrolled in three family support centers (Judith P. Hoyer Early Learning Hubs, "Judy Centers") in Maryland demonstrated good feasibility and acceptability of MB-VG. Investigators also found small to medium effect sizes demonstrating MB-VG effectiveness in reducing depressive symptoms and parenting stress and improving self-efficacy to manage emotions. The investigators are now poised to test MB-VG in a rigorous RCT and propose to conduct a Type 1 Effectiveness-Implementation RCT that enrolls 300 perinatal women (150 MB-VG; 150 controls receiving usual family support services) from across 12 Judy Centers with the following Specific Aims:

Aim 1: To examine MB-VG effectiveness with perinatal immigrant Latinas at risk of PPD. Women receiving MB-VG will exhibit greater reductions in depressive symptoms (Hypothesis 1; H1), exhibit fewer cases of PPD (H2) and report increased parenting self-efficacy and responsiveness (H3) compared to control participants receiving usual family support services. Exploratory Aim: Amongst enrolled participants (n\~150) who have an older child aged 2.5-4.5 years, the study will examine whether the skills taught in MB-VG also promote less child dysregulation and greater child readiness for school.

Aim 2. To evaluate MB-VG implementation. To inform future intervention delivery and scalability, the study will assess key implementation outcomes. Guided by the RE-AIM framework, mixed methods will be employed (e.g., semi-structured interviews, survey data, and session audio-recordings) to assess MB-VG reach, adoption, implementation, and maintenance.

Aim 3. To examine contextual factors influencing MB-VG effectiveness and implementation. Guided by the Consolidated Framework for Implementation Research (CFIR), the study will measure contextual factors at the outer (e.g., participant needs/resources), inner (organizational characteristics), actors (facilitators), intervention and implementation process (virtual) levels via mixed methods.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: We are examining change in depressive symptoms from baseline to 6-months post-intervention
measure: Depressive episodes
timeFrame: We are examining new cases of depressive episodes at 3- and 6-months post-intervention
measure: Parenting self-efficacy
timeFrame: We will examine parenting self-efficacy at 3- and 6-months post-intervention
measure: Parenting responsiveness
timeFrame: We will examine parenting responsiveness at 3- and 6-months post-intervention
Secondary outcomes:
measure: Behavioral activation
timeFrame: We will examine change in behavioral activation between baseline and 6-month post-intervention follow-up
measure: Decentering
timeFrame: We will examine change in decentering between baseline and 6-month post-intervention follow-up
measure: Social support
timeFrame: We will examine change in social support between baseline and 6-month post-intervention follow-up
measure: Mood management
timeFrame: We will examine change in mood management between baseline and 6-month post-intervention follow-up
measure: Anxiety symptoms
timeFrame: We will examine change in anxiety symptoms between baseline and 6-month post-intervention follow-up
measure: Perceived stress
timeFrame: We will examine change in perceived stress between baseline and 6-month post-intervention follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Darius Tandon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Rheanna Platt, MD
role: PRINCIPAL_INVESTIGATOR
References: