Clinical trial NCT05714956: Pilot Study of Mothers and Babies Online in Home Visiting
Official title: Understanding the Needs of Parents and Providers With Mothers and Babies Online (eMB): A User Centered Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: eHealth
Home Visiting
perinatal
depression
perinatal depression
user centered design
digital mental health
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Palo Alto University
name: National Institute of Mental Health (NIMH)
First posted: 2023-02-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Are enrolled in home visiting services
2. Are 16 years or older
3. Are English Proficient (reading, speaking, and writing)
4. Are currently pregnant or have a young child up to 6 months
5. Have internet access
6. Have access to an electronic device (cell phone, laptop, tablet, etc.)
7. 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.

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
Secondary outcomes:
measure: Change in perceived stress
timeFrame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
measure: Change in anxiety symptoms
timeFrame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
measure: Change in parenting sense of competence
timeFrame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
measure: Chang in dimensions of couple relationships
timeFrame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Metropolitan Family Services
state: Illinois
city: Joliet
country: United States
facility: Easter Seals
state: Illinois
city: Chariton
country: United States
facility: South Central Iowa Community Action Program
state: Iowa
city: Hendersonville
country: United States
facility: Children & Family Resource Center
state: North Carolina
city: Greenwood
country: United States
facility: Carolina Health Centers
state: South Carolina
city: Newport News
country: United States
facility: Newport News
state: Virginia
Study officials:
affiliation: Northwestern University
name: Darius Tandon, PhD
role: PRINCIPAL_INVESTIGATOR
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