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Baby2Home Intervention for Postpartum Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Women and Infant's Hospital, Providence, RIPostpartum Depression+4 MoreBaby2Home Mobile Application - Other
Eligibility
18+
All Sexes
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Study Summary

This trial will evaluate a digital health intervention to bridge gaps in obstetrics and pediatrics care for new families, and if it improves health service utilization, patient reported outcomes, and reduces disparities.

Eligible Conditions
  • Coronavirus Pandemic
  • Health Literacy
  • Postpartum Depression
  • Mental Health Wellness

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Baseline through 1 year postpartum

Week 12
Number of participants who attend comprehensive postpartum visit (birthing parent)
Year 1
Concentration of preventive health services utilization for all family members (birthing, non-birthing, and infant)
Month 1
Anxiety symptoms (for birthing and non-birthing parent)
Breastfeeding self-efficacy (for birthing parent)
COVID-19 related impact (for birthing and non-birthing parent)
Depressive symptoms (for birthing and non-birthing parent)
Global health status (for birthing and non-birthing parent)
Parenting self-efficacy (for birthing and non-birthing parent)
Relationship assessment (for birthing and non-birthing parent)
Self-efficacy (for birthing and non-birthing parent)
Stress symptoms (for birthing and non-birthing parent)
Month 12
Completion of postnatal depression screening for non-birthing parent
Completion of postpartum depression screening and treatment (birthing parent)
Number of participants who attended well-child visits for the infant
Number of participants who attendend well-child visits for the infant
Number of participants who received contraception (birthing and non-birthing parent)
Vaccination
Number of participants who received the recommended vaccinations for infant
Month 6
Breast Milk Expression
Duration of breastfeeding (birthing parent)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Patient Navigation Program
1
ASSET-PPD intervention group
1
FreshRx Nourishing Healthy Starts

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Baby2Home Intervention
1 of 2

Active Control

Experimental Treatment

640 Total Participants · 2 Treatment Groups

Primary Treatment: Baby2Home Intervention · No Placebo Group · N/A

Baby2Home Intervention
Other
Experimental Group · 1 Intervention: Baby2Home Mobile Application · Intervention Types: Other
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through 1 year postpartum

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
100 Previous Clinical Trials
36,114 Total Patients Enrolled
2 Trials studying Postpartum Depression
412 Patients Enrolled for Postpartum Depression
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,164 Total Patients Enrolled
5 Trials studying Postpartum Depression
3,605 Patients Enrolled for Postpartum Depression
Craig Craig, MDStudy DirectorLurie Children's Hospital

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have never given birth to a child who was born alive before.
You need to have a smartphone.
References

Frequently Asked Questions

What is the maximum capacity of participants for this research endeavor?

"Yes, the information posted on clinicaltrials.gov confirms that this trial is still open and actively recruiting participants. It was first published on November 9th 2022 with recent edits made on November 10th 2022; they are looking to enrol 640 patients from two different sites." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this clinical trial?

"Affirmative, clinicaltrials.gov's records indicate that this study is actively seeking participants. It was initially published on November 9th 2022 and underwent the last amendment a day later. The trial requires 640 individuals for two different facilities." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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