Pilot Study of Mothers and Babies Online in Home Visiting

Study Overview
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Brief Summary
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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
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This pilot study examining how to incorporate Mothers and Babies Online or eMB into home visiting program workflows will have three Specific Aims: 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. 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. 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.

Official Title
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Understanding the Needs of Parents and Providers With Mothers and Babies Online (eMB): A User Centered Approach

Conditions
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Perinatal Depression

Intervention / Treatment
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* Behavioral: Mothers and Babies Online (eMB)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>eMB consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention. | Behavioral: Mothers and Babies Online (eMB)<br>* This study's intervention is called Mothers and Babies Online or eMB, which consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention.<br>|
| No Intervention: Home Visiting Usual Care<br>Core content of home visiting program services typically address: (a) preparation for childbirth and having a young child in the home, (b) provision of emotional and tangible [e.g., diapers, formula] support, (c) discussion of infant and young child development, (d) linkages to prenatal and pediatric care, and (e) referrals to community resources for social and health services. Those receiving usual care home visiting will not receive any eMB or MB course content. Once study participation is completed, the home visitor may introduce eMB to the participant if they are interested. Participants in the control group will also complete assessments at baseline, 1 week post-intervention (i.e., following 8 weeks of usual home visiting services), and 3 months post-intervention (i.e.g, following 8 weeks of usual home visiting services). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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 | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived stress | Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), which asks respondents to indicate their levels of perceived stress in the last month, with a response of 0 indicating Never and a response of 4 indicating very often. | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) | 
| Change in anxiety symptoms | Symptoms of anxiety will be measured using the Generalized Anxiety Disorder-7, which is a 7-item measure that aligns with the Diagnostic and Statistical manual of Mental Disorders (DSM-5) criteria for GAD and assesses anxiety symptom frequency and severity. This instrument has scores ranging from 0-21 with higher scores indicating greater anxiety symptoms. | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) | 
| Change in parenting sense of competence | Parenting sense of competence (PSOC) is a 17-item scale developed to assess parenting self-esteem. The scale includes two rationally derived scales, Skill-Knowledge and Value-Comforting, referred to as Efficacy and Satisfaction. Each item is answered on a 6-point scale ranging from strongly disagree (6) to strongly agree (1). | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) | 
| Chang in dimensions of couple relationships | Dimensions of couple relationships will be measured using the Revised Dyadic Adjustment Scale , a report questionnaire that assesses seven dimensions of couple relationships within three overarching categories including consensus in decision making, values and affection, satisfaction in the relationship with respect to stability and conflict regulation, and cohesion. Scores range from 0-69 with higher scores indicating stronger relationships. | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, Home Visiting, perinatal, depression, perinatal depression, user centered design, digital mental health