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eMB Program for Postpartum Depression (eMB Trial)

N/A

Waitlist Available

Led By Darius Tandon, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 16 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (prior to starting intervention), t2 (1 week post-intervention), t3 (3 months post-intervention)

Awards & highlights

eMB Trial Summary

This trial aims to explore if an online version of a successful in-person maternal health intervention can be used in home visiting programs across the US.

Who is the study for?

This trial is for pregnant individuals or new mothers enrolled in home visiting services, aged 16 or older, with internet and electronic device access. Participants should be at risk for perinatal depression indicated by certain scores on depression scales, personal or family history of depression, and must be English proficient.Check my eligibility

What is being tested?

The study tests the online version of Mothers and Babies (eMB), a program aimed to support mental health during pregnancy and postpartum. It's delivered through home visiting services to see if it helps prevent perinatal depression compared to standard care.See study design

What are the potential side effects?

Since eMB is a non-medical intervention focusing on education and emotional support through an online platform, there are no direct physical side effects like those associated with medications. However, participants may experience varying levels of emotional discomfort.

eMB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

eMB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (prior to starting intervention), t2 (1 week post-intervention), t3 (3 months post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (prior to starting intervention), t2 (1 week post-intervention), t3 (3 months post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (prior to starting intervention), t2 (1 week post-intervention), t3 (3 months post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in depressive symptoms

Secondary outcome measures

Chang in dimensions of couple relationships

Change in anxiety symptoms

Change in parenting sense of competence

+1 more

eMB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

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.

Group II: Home Visiting Usual CareActive Control1 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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,181 Total Patients Enrolled

8 Trials studying Postpartum Depression

2,050 Patients Enrolled for Postpartum Depression

Palo Alto UniversityOTHER

12 Previous Clinical Trials

7,845 Total Patients Enrolled

1 Trials studying Postpartum Depression

300 Patients Enrolled for Postpartum Depression

National Institute of Mental Health (NIMH)NIH

2,783 Previous Clinical Trials

2,689,077 Total Patients Enrolled

25 Trials studying Postpartum Depression

8,143 Patients Enrolled for Postpartum Depression

Media Library

Mothers and Babies Online (eMB) Clinical Trial Eligibility Overview. Trial Name: NCT05714956 — N/A

Postpartum Depression Research Study Groups: Home Visiting Usual Care, Intervention

Postpartum Depression Clinical Trial 2023: Mothers and Babies Online (eMB) Highlights & Side Effects. Trial Name: NCT05714956 — N/A

Mothers and Babies Online (eMB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714956 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently offer enrollment opportunities?

"According to clinicaltrials.gov, this particular trial has ceased recruitment; however, the original posting date was February 1st 2023 and it had been updated as recently as February 2nd 2023. Concurrently, there are 1137 other medical trials that require participants at present."

Answered by AI

How many venues are administering this trial?

"At present, 6 trial sites are available for this clinical research. These include Easter Seals in Joliet, South Central Iowa Community Action Program in Chariton, and Children & Family Resource Center in Hendersonville with 3 other locations also partaking."

Answered by AI

Recent research and studies

Maternal and Child Health JournalJournal

Six-month Outcomes from a Randomized Controlled Trial to Prevent Perinatal Depression in Low-income Home Visiting Clients

Tandon, S. Darius, Julie A. Leis, Tamar Mendelson, Deborah F. Perry, and Karen Kemp. 2013. “Six-month Outcomes from a Randomized Controlled Trial to Prevent Perinatal Depression in Low-income Home Visiting Clients”. Maternal and Child Health Journal. Springer Science and Business Media LLC. doi:10.1007/s10995-013-1313-y.

clinicaltrials.govStudy

Pilot Study of Mothers and Babies Online in Home Visiting

Darius Tandon 2023. "Pilot Study of Mothers and Babies Online in Home Visiting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714956.

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