Baby2Home Mobile Application for Mental Health Wellness

Not currently recruiting at 1 trial location

Overseen By Joshua Santiago, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Severe mental illness, NICU, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Baby2Home to determine if it helps new families receive better healthcare for themselves and their babies during the first year after birth. The app aims to enhance health service use and reported health outcomes for parents while reducing disparities in health services related to race or income. The trial compares families using the app to those receiving usual care to identify which group benefits more. It is suitable for first-time parents who have given birth to a full-term baby at specific hospitals and have access to a smartphone and email. As an unphased trial, this study offers families a unique opportunity to contribute to innovative healthcare solutions and potentially experience improved health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Baby2Home Mobile Application is safe for mental health wellness?

Research shows that specific safety information for the Baby2Home Mobile Application is not available. However, this app is a digital health tool, generally considered low-risk compared to other medical treatments. It supports new parents by providing educational content and reminders about healthcare services. As a mobile app, it does not pose concerns about side effects or adverse reactions like medications do.

Users of similar digital health tools typically encounter very few issues. Any potential problems are more likely related to app functionality rather than health risks. Users should follow all provided guidelines and instructions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard postpartum care, which typically involves in-person visits and screenings, the Baby2Home Mobile Application offers a digital, app-based approach to mental health wellness for new parents. This app combines AI-driven communication with educational content, reminders, and scheduling tools, making it easier for families to manage self-care and newborn care after leaving the hospital. Researchers are excited about this treatment because it leverages technology to provide continuous support and education, potentially increasing adherence to preventive healthcare services and improving overall outcomes for parents and infants.

What evidence suggests that the Baby2Home Mobile Application is effective for improving postpartum health outcomes?

Research has shown that the Baby2Home mobile app helps new families adjust to parenthood. In this trial, some participants will receive the Baby2Home Intervention, which combines features from successful programs like the NICU2Home+ app and team-based care services. Early results suggest that digital tools like Baby2Home can enhance mental health and caregiving for new parents. The app uses smart technology to offer tips on self-care and newborn care, and it sends reminders for important health check-ups. This approach aims to improve the use of health services and outcomes for both parents and babies. ^{1 2 3 5 6}

Who Is on the Research Team?

Craig Craig, MD

Principal Investigator

Lurie Children's Hospital

Are You a Good Fit for This Trial?

This trial is for new parents with a healthy, full-term baby (≥37 weeks) born at specific hospitals. Participants must be over 18, speak English, have smartphone access and an email address. It's not for those whose infant passed away or needs NICU care, have severe mental illness, are in certain other studies, experienced IPV with the current partner or lack clinical clearance post-COVID-19 infection.

Inclusion Criteria

I have a working email address.

Delivery at Prentice Women's Hospital or Women and Infants Hospital of Rhode Island

Access to a smartphone

Exclusion Criteria

Concurrent enrollment in studies that may affect the outcome of the trial (or vice versa)

Babies who have passed away.

My infant needs to be admitted to the NICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families receive the Baby2Home (B2H) digital health intervention via a smartphone app, which includes parental education, infant wellness resources, mental health screening, and support.

12 months

Baseline, 1M, 2M, 4M, 6M, and 12M

Follow-up

Participants are monitored for health service utilization and patient-reported outcomes over the first year postpartum.

12 months

Ongoing monitoring through app and surveys

What Are the Treatments Tested in This Trial?

Interventions

• Baby2Home Mobile Application

Trial Overview The Baby2Home Mobile Application is being tested to see if it can improve healthcare service use and parental outcomes during the first year after birth compared to usual care. The study also looks at whether it reduces health disparities based on race/ethnicity and income.

How Is the Trial Designed?

Group I: Baby2Home Intervention Experimental Treatment 1 Intervention

Families randomized to the intervention arm will receive the B2H services. B2H is a novel digitized CC-based intervention delivered via a smartphone app available on iOS or Android phones, built by combining two successful programs: NICU2Home+ app and CC services. Using the UCD methodologies, AI-based communication within the app will include education for mothers and fathers on the standard of care regarding self-care and newborn care after hospital discharge as well as education, reminders and scheduling for recommended preventative healthcare services for themselves and their new infant.

Group II: Usual Care Active Control 1 Intervention

As a pragmatic trial, usual care will be defined by contemporary clinical standards. For maternal care, this includes a comprehensive medical visit between 4-12 weeks postpartum. This visit includes utilization of a validated screen for postpartum depression and, if that screen is positive, a clinical assessment and initiation of treatment (e.g. pharmacotherapy or referral for psychotherapy). In addition, this visit includes a discussion of contraception as well as supportive education on breastfeeding. For paternal care, clinical standards are gleaned from the AAP, ACOG, and USPSTF reports outlining mental health screening, reproductive health, and vaccine uptake. For infant care, standard pediatric care from the AAP and Bright Futures periodicity timeline and guidelines will be used. In addition, assignment in this arm will be given surveys at baseline, 1M, 2M, 4M, 6M, and 12M.

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Research on mobile apps for women with perinatal mood disorders shows a significant disconnect between academic studies and commercially available apps, with most academic interventions lacking presence in app stores and vice versa.

The review highlights the need for improved collaboration between academia and industry to enhance the quality and effectiveness of mHealth interventions for perinatal mental health, along with proposed practice guidelines for better implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of mHealth application interventions for peripartum mood disorders: trends and evidence in academia and industry. Feldman, N., Back, D., Boland, R., et al.[2021]

The mobile application 'Ebe Evimde (My Home Midwife)' significantly improved self-efficacy levels in mothers during the postpartum period, as evidenced by a notable difference between pretest and posttest scores in the intervention group of 60 mothers.

The application also effectively reduced postpartum anxiety levels, showing a strong negative relationship between pretest and posttest anxiety scores in the intervention group, while no significant changes were observed in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the Ebe Evimde application on the self-efficacy and anxiety levels of mothers: Randomized controlled trial. Bozkurt, MA., Cesur, B.[2023]

The mood tracking and alert (MTA) mobile app significantly increased mental health care contacts for pregnant women with depressive symptoms, leading to better management of their health compared to those using a standard patient portal app.

Women using the MTA app were more likely to receive referrals to mental health specialists, highlighting its effectiveness in improving service delivery and patient engagement in a high-risk obstetric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Monitoring and Management of Depressed Mood in a Vulnerable Pregnant Population. Hantsoo, L., Criniti, S., Khan, A., et al.[2019]

The mobile application 'Happy Mother' was developed to help manage postpartum depression using principles of cognitive behavioral therapy, making it a potentially effective tool for mothers seeking self-management options without needing to visit a healthcare facility.

Usability testing showed that the app successfully increased awareness of mood and provided practical self-management strategies, indicating its potential to improve mental health outcomes for postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Postpartum Depression Self-Management Mobile Application "Happy Mother". Seo, JM., Kim, SJ., Na, H., et al.[2023]

Mobile application-based interventions have been found to be feasible and promising in improving parental well-being during the perinatal period, particularly in enhancing parenting self-efficacy, anxiety, and depression, based on a review of 12 studies involving various intervention types.

The review suggests that incorporating educational resources, psychotherapy, and peer support into these mobile interventions can further benefit parents, although more research is needed to assess the long-term effects and to include a more diverse participant population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile application-based perinatal interventions in improving parenting outcomes: A systematic review. Chua, JYX., Shorey, S.[2022]

Young people generally engage well with mobile-based mental health apps, showing some positive effects on emotional self-awareness, although many outcomes were not statistically significant.

Despite the potential of these apps to improve access to mental health services and support self-help, the current literature is limited, highlighting the need for more research to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile apps and technologies in child and adolescent mental health: a systematic review. Punukollu, M., Marques, M.[2023]

A mobile phone self-monitoring tool for mental health was used by 47 adolescents over 2-4 weeks, showing high engagement with 91% of entries completed in the first week.

Paediatricians found the tool beneficial, with 92% of them reporting it helped them understand their patients better, and 88% of participants felt the data accurately reflected their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. Reid, SC., Kauer, SD., Khor, AS., et al.[2019]

Digital health technologies can significantly enhance the management and screening of peripartum depression (PPD), which affects 10-15% of women in the U.S. annually, by utilizing a tailored framework called Digilego.

The development of specific digital features, such as 'My Diary' and 'Mom Talk', aims to improve patient engagement and address the unique needs of women experiencing PPD, with initial evaluations suggesting these features may provide technological advantages over existing solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digilego for Peripartum Depression: A Novel Patient-Facing Digital Health Instantiation. Zingg, A., Rogith, D., Refuerzo, JS., et al.[2021]

Citations

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Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

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Baby2Home (B2H) Mobile Health Application Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12421202/

Qualitative Interview Study of the Baby2Home Intervention ... The postpartum period represents a critical period for both birthing and nonbirthing parents due to mental health concerns and new caregiving demands.

4. withpower.com withpower.com/trial/phase-covid-19-9-2022-edcf1

Baby2Home Mobile Application for Mental Health Wellness This N/A medical study run by Women and Infants Hospital of Rhode Island needs participants to evaluate whether Baby2Home Mobile Application will have ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11197884/

The Design and Implementation of a Multi-center, ... Baby2Home (B2H) is a digital intervention built on the collaborative care model (CCM) designed to support families during these transitions to parenthood.

6. baby2home.com baby2home.com/23_terms__condition/

Terms Of Use Baby2Home supports new parents with milestone tracking, wellness info, self-tracking, and care manager support. Users must be 18+, and agree to ...