Pilot Study of Mothers and Babies Online in Home Visiting

NCT05714956 | Completed

• 2 other identifiers: STU002167635P50MH119029-03
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Perinatal Depression

Keywords

eHealth; Home Visiting; perinatal; depression; perinatal depression; user centered design; digital mental health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in perceived stress

  T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

• Change in anxiety symptoms

  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)

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Home Visiting Usual Care

NO INTERVENTION

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).

Interventions

Mothers and Babies Online (eMB) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Palo Alto University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

Metropolitan Family Services

Chicago, Illinois, 60606, United States

Location

Easter Seals

Joliet, Illinois, 60435, United States

Location

South Central Iowa Community Action Program

Chariton, Iowa, 50049, United States

Location

Children & Family Resource Center

Hendersonville, North Carolina, 28792, United States

Location

Carolina Health Centers

Greenwood, South Carolina, 29646, United States

Location

Newport News

Newport News, Virginia, 23607, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Darius Tandon, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Public Health and Medicine (IPHAM) - Center for Community Health; Associate Professor of Medical Social Sciences

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (6)