Baby2Home Mobile Application for Mental Health Wellness

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

642 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Baby2Home, a digital program to help new parents and their babies. It aims to improve health outcomes and reduce disparities for families affected by COVID-19. The program provides education, wellness tracking, mental health support, and regular check-ins.

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 data supports the effectiveness of the Baby2Home Mobile Application treatment for mental health wellness?

Research on similar digital health technologies for peripartum depression suggests that mobile applications can improve mental health outcomes by offering anonymity, flexibility, and promoting help-seeking. These apps are seen as beneficial for perinatal mental health, especially when they are customizable and user-friendly. ^{1 2 3 4 5}

Is the Baby2Home Mobile Application generally safe for use in humans?

There is no specific safety data available for the Baby2Home Mobile Application, but mobile health apps in general are considered safe as they primarily provide information and support without direct medical intervention. ^{2 6 7 8 9}

How does the Baby2Home Mobile Application treatment differ from other treatments for mental health wellness in new parents?

The Baby2Home Mobile Application is unique because it provides mental health support for new parents through a mobile app, making it convenient and accessible. Unlike traditional face-to-face therapy, this app offers anonymity and flexibility, which can help overcome barriers to seeking help and improve adherence to mental health interventions. ^{5 10 11 12 13}

Research Team

Craig Craig, MD

Principal Investigator

Lurie Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Mobile Application for Monitoring and Management of Depressed Mood in a Vulnerable Pregnant Population. [2019]

2. Austria pubmed.ncbi.nlm.nih.gov

A systematic review of mHealth application interventions for peripartum mood disorders: trends and evidence in academia and industry. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Digilego for Peripartum Depression: A Novel Patient-Facing Digital Health Instantiation. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Investigating perspectives on e-health interventions to enhance maternal mental well-being: Results of a stakeholder interview. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Development of the Postpartum Depression Self-Management Mobile Application "Happy Mother". [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Mobile applications as a strategy to support parents in the care of newborns: a scoping review. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Designing a Mobile Health Solution to Facilitate the Transition from NICU to Home: A Qualitative Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of a mobile technology-based intervention for increasing parents' safety knowledge and actions: a randomized controlled trial. [2021]

10. Scotland pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol. [2019]