Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-01-25
Brief Title:
Pilot Study of Mothers and Babies Online in Home Visiting
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Understanding the Needs of Parents and Providers With Mothers and Babies Online eMB A User Centered Approach
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
eMB
Brief Summary:
The investigators propose a pilot randomized controlled trial RCT that examines how the redesigned version of Mothers and Babies Online eMB can be delivered in the context of home visiting HV programs that serve pregnant individuals and new mothers across the United States The PI Dr Darius Tandon Northwestern University has conducted extensive research on the in-person Mothers and Babies MB intervention with HV programs and has received interest from one of the largest HV models-Parents as Teachers PAT-to explore the use of eMB with pregnant individuals that they serve
Detailed Description:
This pilot study examining how to incorporate Mothers and Babies Online or eMB into home visiting program workflows will have three Specific Aims
1 Employ a user-centered design UCD approach in which investigators will conduct semi-structured qualitative interviews with key home visiting stakeholders n 10 parent clients n 5 home visitors to generate recommendations on a how to integrate eMB into home visiting program workflows b appropriate strategies for home visitors providing human support to support eMB engagement c reactions to the messaging and tone of eMB and c potential barriers and facilitators to eMB engagement
2 Conduct a small randomized trial that examines the feasibility acceptability and effectiveness of eMB when implemented in home visiting programs Investigators will recruit 50 pregnant individuals and new mothers from 5-8 Parents as Teachers programs that serve rural communities Investigators have chosen to focus on rural communities given the challenges associated with in-person intervention delivery in those settings These individuals will be randomized where 40 individuals will complete the eMB intervention and 10 will serve as controls receiving usual HV services Participants who are at-risk for developing postpartum depression will be eligible for the study Investigators will assess risk for postpartum depression using two screening tools-the Edinburgh Postnatal Depression Scale EPDS and the Postpartum Depression Predictors Inventory PDPI Women scoring in the mildmoderate range 5-14 on the EPDS or scoring 35 on the PDPI are considered at elevated risk for postpartum depression Data from the UCD phase will be used to develop study protocols for implementing eMB including how home visitors providing human supportcoaching while clients are engaged with eMB Investigators will collect maternal self-report data on depressive symptoms perceived stress and other mental health outcomes at baseline pre-intervention 1-week post-intervention and 3-months post-intervention
3 Conduct brief semi-structured interviews with n 15 parent clients who received eMB during the pilot RCT and n 5 home visitors who provided eMB coaching during the pilot RCT to understand user experience with eMB with particular emphasis on understanding any human supportcoaching component which will guide any necessary modifications to the intervention protocol Investigators will also conduct brief semi-structured interviews with program managers from participating Parents as Teachers PAT programs and PAT leadership to assess organizational-level barriers and facilitators to eMB uptake which will inform future research directions related to the implementation of eMB
1 Employ a user-centered design UCD approach in which investigators will conduct semi-structured qualitative interviews with key home visiting stakeholders n 10 parent clients n 5 home visitors to generate recommendations on a how to integrate eMB into home visiting program workflows b appropriate strategies for home visitors providing human support to support eMB engagement c reactions to the messaging and tone of eMB and c potential barriers and facilitators to eMB engagement
2 Conduct a small randomized trial that examines the feasibility acceptability and effectiveness of eMB when implemented in home visiting programs Investigators will recruit 50 pregnant individuals and new mothers from 5-8 Parents as Teachers programs that serve rural communities Investigators have chosen to focus on rural communities given the challenges associated with in-person intervention delivery in those settings These individuals will be randomized where 40 individuals will complete the eMB intervention and 10 will serve as controls receiving usual HV services Participants who are at-risk for developing postpartum depression will be eligible for the study Investigators will assess risk for postpartum depression using two screening tools-the Edinburgh Postnatal Depression Scale EPDS and the Postpartum Depression Predictors Inventory PDPI Women scoring in the mildmoderate range 5-14 on the EPDS or scoring 35 on the PDPI are considered at elevated risk for postpartum depression Data from the UCD phase will be used to develop study protocols for implementing eMB including how home visitors providing human supportcoaching while clients are engaged with eMB Investigators will collect maternal self-report data on depressive symptoms perceived stress and other mental health outcomes at baseline pre-intervention 1-week post-intervention and 3-months post-intervention
3 Conduct brief semi-structured interviews with n 15 parent clients who received eMB during the pilot RCT and n 5 home visitors who provided eMB coaching during the pilot RCT to understand user experience with eMB with particular emphasis on understanding any human supportcoaching component which will guide any necessary modifications to the intervention protocol Investigators will also conduct brief semi-structured interviews with program managers from participating Parents as Teachers PAT programs and PAT leadership to assess organizational-level barriers and facilitators to eMB uptake which will inform future research directions related to the implementation of eMB
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P50MH119029-03 | NIH | None | httpsreporternihgovquickSearch5P50MH119029-03 |