Understanding the Needs of Parents and Providers With Mothers and Babies Online (eMB): A User Centered Approach
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Perinatal Depression
- Sponsor
- Northwestern University
- Enrollment
- 42
- Locations
- 6
- Primary Endpoint
- Change in depressive symptoms
- Status
- Completed
- Last Updated
- last year
Overview
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 mild/moderate range (5-14) on the EPDS or scoring \>3.5 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 support/coaching 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 support/coaching 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.
Investigators
Darius Tandon
Director, Institute for Public Health and Medicine (IPHAM) - Center for Community Health; Associate Professor of Medical Social Sciences
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •Are enrolled in home visiting services
- •Are 16 years or older
- •Are English Proficient (reading, speaking, and writing)
- •Are currently pregnant or have a young child up to 6 months
- •Have internet access
- •Have access to an electronic device (cell phone, laptop, tablet, etc.)
- •Are at risk for developing perinatal depression as defined by one or more of the following: a score of 5-14 on the Edinburgh Postnatal Depression Scale (EPDS), a score of \>3.5 on the Postpartum Depression Predictors Inventory (PDPI), personal history of depression, and/or familial history of depression.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in depressive symptoms
Time Frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
Depression will be assessed using the Center for Epidemiological Studies-Depression Scale, which is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0-60 with higher scores indicating greater depressive symptomatology
Secondary Outcomes
- Change in anxiety symptoms(T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention))
- Change in perceived stress(T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention))
- Change in parenting sense of competence(T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention))
- Chang in dimensions of couple relationships(T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention))