RECRUITING

Preventing Postpartum Depression in Immigrant Latinas

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention

Quick Facts

Study Start:2023-10-15
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05873569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identify as Latina
  2. * Speak Spanish
  3. * Be at least 16 years old
  4. * Be pregnant or have a child \<9 months
  5. * Have access to a device they can use for MB-VG sessions.
  6. * 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.
  1. * Individuals who score \>14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus.
  2. * Individuals not at risk for PPD-i.e., EPDS scores \<5 and under the PDPI-R cutoff-will also be excluded.

Contacts and Locations

Study Contact

Darius Tandon, PhD
CONTACT
410-852-0399
dtandon@northwestern.edu
Lindsay Cooper, MA
CONTACT
lcoope45@jhmi.edu

Principal Investigator

Darius Tandon, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Rheanna Platt, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Darius Tandon, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University Feinberg School of Medicine
  • Rheanna Platt, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-15
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-10-15
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Postpartum Depression