Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05873569
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2023-05-15
Brief Title:
Preventing Postpartum Depression in Immigrant Latinas
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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-ie 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 racialethnic 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 n150 who have an older child aged 25-45 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 eg 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 eg participant needsresources inner organizational characteristics actors facilitators intervention and implementation process virtual levels via mixed methods
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 racialethnic 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 n150 who have an older child aged 25-45 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 eg 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 eg participant needsresources inner organizational characteristics actors facilitators intervention and implementation process virtual levels via mixed methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None