COVID-19 PandemicNCT05595486
Baby2Home (B2H) Mobile Health Application
A study testing Baby2Home Mobile Application in people with COVID-19 Pandemic and Health Knowledge, Attitudes, Practice, run by Women and Infants Hospital of Rhode Island at 2 sites in United States.
Trial summary
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic, Health Knowledge, Attitudes, Practice, Perinatal Depression
- What is being tested?
- Baby2Home Mobile Application
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2022to 25 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delivery at Prentice Women's Hospital or Women and Infants Hospital of Rhode Island
- Viable term infant (≥ 37 weeks)
- First live born child
- English speaking
- Age 18 years old or greater
- Access to a smartphone
- Access to a working email address
Who cannot join
- No smartphone access
- Infant death
- Infant requires NICU admission
- Known severe mental illness of either parent (e.g., bipolar disorder, schizophrenia)
- SARS-CoV-2 infection without clinical clearance
- History of IPV (intimate partner violence) with current partner (would exclude partner)
- Concurrent enrollment in studies that may affect the outcome of the trial (or vice versa)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
Women and Infant's Hospital
Providence, Rhode Island, 02905
About this study
Official title: Baby2Home (B2H) Mobile Health Application: A Randomized-Controlled Trial
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes.
Read the detailed description
The transition to new parenthood is marked by dramatic changes in social roles and responsibilities. To support new parents, obstetric and pediatric healthcare surrounding this transition is designed with a supportive focus to facilitate new parents' navigation of the attendant life changes. The COVID-19 pandemic has altered healthcare delivery in ways that have limited these supportive obstetrics and pediatric services provided at the beginning of new parenthood. Consequently, aspects of preventative healthcare, such as monitoring for symptoms of postpartum depression, discussing optimal birth control options, educating parents on recommended adult and pediatric vaccinations, and providing anticipatory guidance on infant wellness, are less robust. In addition, without professional guidance and support, outcomes of foundational importance to new parents, such as perceived stress, depressive and anxiety symptoms, or parenting and breast-feeding self-efficacy, are worse. Moreover, the COVID-19 pandemic has underscored the impact of the social determinants of health on new family wellness, with racial/ethnic minority and low-income families being differentially impacted by COVID-19 pandemic driven healthcare delivery changes. Recognizing the potential for longitudinal changes in healthcare delivery engendered by the COVID-19 pandemic, a scalable, patient-centered, equity-focused intervention designed to bridge gaps in healthcare services around the transition to new parenthood is needed.
"Bridging gaps in healthcare delivery to COVID-19 for parent and infants from birth through the first year of life" aims to evaluate Baby2Home (B2H) a patient-informed digital healthcare intervention that s is specifically responsive to the COVID-19 pandemic's impact on new families, with a focus on health equity for racial/ethnic minority and low-income families. B2H builds upon previous digital health successes while incorporating the evidence-based collaborative care model for mental health support. B2H is designed to mitigate the adverse effects of healthcare delivery changes in response to the COVID-19 pandemic and to improve health for mothers, fathers, and infants over the first year of life. Developed from feedback given by new parents who delivered during the COVID-19 pandemic, B2H provides 1) parental education about their own physical and mental health, 2) infant wellness resources and tracking of recommended healthcare services, 3) parental mental health screening and support, and 4) systematic case review to optimize the health of new families. The investigators will test the efficacy of B2H via a randomized control trial. In total, 640 diverse families will be randomly to either usual care or B2H intervention arm to evaluate whether, compared to usual care, B2H health services utilization and patient reported outcomes of foundational important to new families. addition, the investigators will evaluate the impact of B2H on racial/ethnic and income-based disparities observed in both services utilization and patient reported outcomes.
- Conditions
- COVID-19 Pandemic, Health Knowledge, Attitudes, Practice, Perinatal Depression, Mental Health Wellness, Post Partum Depression
- Being tested
- Baby2Home Mobile Application
- Medical subject headings
- COVID-19, Behavior, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby2Home Mobile ApplicationOther
Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No 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. |
| Baby2Home Intervention | Experimental | 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. Receives: Other: Baby2Home Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)
The primary outcome defined as positive if all of the items below are met for all family members:
- optimal maternal preventive health services utilization over the 1st year postpartum (including attendance at the comprehensive postpartum visit, receives chosen contraceptive method, and undergoes postpartum depression screening)
- optimal paternal/co-parental preventive health services utilization over the 1st year postpartum (including receiving recommended vaccinations for new parents, if desires a male-driven contraceptive option, receives chosen method, and undergoes screening for depression)
- optimal infant preventive health services utilization over the 1st year postpartum (including attending all AAP recommended wellness visits, receiving all AAP recommended vaccines, and receiving breast milk for 6 months of life)
Measured: Baseline through 1 year postpartum
Secondary outcomes (17)
Number of participants who attend comprehensive postpartum visit (birthing parent)
Subject returns for a comprehensive medical care at least once between 4 and 12 weeks postpartum. This visit should include documented elements of physical health, mood, mode of infant feeding, contraception, preventive health, and any comorbidities.
Measured: At least once between 4 and 12 weeks postpartum
Completion of postpartum depression screening (birthing parent)
Subject completes a validated screen for postpartum depression and, if the screen is positive, receives a recommendation for treatment. To assess depressive symptoms, birthing will take the 9-item Patient Health Questionnaire (PHQ). This is scored on a Likert-type scale from 0 - 3 (Not at all to Nearly everyday). A lower score reflects minimal depression and a higher score reflects severe depression.
Measured: Through study completion, up to 12 months
Number of participants who received contraception (birthing and non-birthing parent)
If a subject desires a contraceptive method, they receives chosen method. Receipt of contraception can be an actual insertion of device (implant or IUD), receipt of injection, receipt of sterilization (BTL or vasectomy, if vasectomy is confirmed to have been performed), or prescription for a combined hormonal contraceptive method.
Measured: Through study completion, up to 12 months
Number of participants who received the recommended vaccinations (non-birthing parent)
Subject receives influenza and TDaP vaccines before 12 months postpartum.
Measured: Through study completion, up to 12 months
Completion of postnatal depression screening for non-birthing parent
Subject completes a validated screen for depression. To assess depressive symptoms, non-birthing parents will take the 9-item Patient Health Questionnaire (PHQ). This is scored on a Likert-type scale from 0 - 3 (Not at all to Nearly everyday). A lower score reflects minimal depression and a higher score reflects severe depression.
Measured: Through study completion, up to 12 months
Number of participants who attended well-child visits for the infant
Subject attends all AAP recommended wellness visits. Attendance at each visit will be derived from both patient-report (via B2H) and through ROIs from the pediatrician offices. Preference will be given to the ROIs, but if this not available, patient-report will be used as equal. If these data points are conflicting, patient-report will supersede the medical record.
Measured: Through study completion, up to 12 months
Number of participants who received the recommended vaccinations for infant
Subject receives all AAP recommended vaccinations. This information will be ascertained from the ROIs from the pediatrician offices. Recognizing various vaccine schedules, this will be determined as a binary variable at 12 months postpartum (and the % of vaccines received).
Measured: Through study completion, up to 12 months
Continued breastfeeding for infants until 6 months
This outcome will be patient-reported. The investigators will evaluate this outcome as positive if breastmilk is a source of nutrition until 6 months.
The primary analysis will be of all subjects who were eligible for breastfeeding (i.e., excluding those unable to breastfeed due to a medical complication). Investigators will perform secondary analyses in which individuals who do not desire breastfeeding and did not initiate breastfeeding will not be considered in this component of outcomes.
Measured: Through study completion, up to 6 months
Duration of breastfeeding (birthing parent)
This outcome will be patient-reported. The investigators will also evaluate as an ordinal outcome of total duration (months) of any breastfeeding and total duration (months) of exclusive breastfeeding.
The primary analysis will be of all subjects who were eligible for breastfeeding (i.e., excluding those unable to breastfeed), but the investigators will perform secondary analyses in which individuals who do not desire breastfeeding and did not initiate breastfeeding will not be considered in this component of outcomes.
Measured: Through study completion, up to 6 months
Patient reported outcomes: stress symptoms (for birthing and non-birthing parent)
To assess stress, birthing and non-birthing parents will take the 10-item Perceived Stress Scale (PSS). This is scored on a Likert-type scale from 0 - 4 (Never to Very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: depressive symptoms (for birthing and non-birthing parent)
To assess depressive symptoms, birthing and non-birthing parents will take the 9-item Patient Health Questionnaire (PHQ). This is scored on a Likert-type scale from 0 - 3 (Not at all to Nearly everyday). A lower score reflects minimal depression and a higher score reflects severe depression.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: anxiety symptoms (for birthing and non-birthing parent)
To assess anxiety, birthing and non-birthing parents will take the 7-item Generalized Anxiety Disorder Scale. This is scored on a Likert-type scale from 0 - 3 (Not at all to Nearly everyday). A lower score reflects minimal anxiety and a higher score reflects severe anxiety.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: global health status (for birthing and non-birthing parent)
To assess health status, birthing and non-birthing parents will take the 10-item PROMIS Global Health Scale. This is scored on a Likert-type scale from 5 - 1 (Excellent to Poor). A higher score indicates better health status.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: relationship assessment (for birthing and non-birthing parent)
To assess relationship status, birthing and non-birthing parents will take the 14-item Revised Dyadic Adjustment Scale (RDAS). This is scored on a Likert-type scale from 0 - 5 (Everyday to Never). Scores on the RDAS range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. The cut-off score for the RDAS is 48 such that scores of 48 and above indicate non-distress and scores of 47 and below indicate marital/relationship distress.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: self-efficacy (for birthing and non-birthing parent)
To assess self-efficacy, birthing and non-birthing parents will take the 10-item PROMIS Self-Efficacy Scale. This is scored on a Likert-type scale from 1 - 5 (I am not at all confident to I am very confident). A higher score indicates a higher sense of general self-efficacy.
Measured: Month 1, 2, 4, 6, and 12
Patient reported outcomes: parenting self-efficacy (for birthing and non-birthing parent)
To assess parenting self-efficacy, birthing and non-birthing parents will take the 17-item Parenting Sense of Competence Scale. This is scored on a Likert-type scale from 1 - 6 (Strongly Disagree to Strongly Agree). A higher score indicates a higher parenting sense of competency.
Measured: Month 12
Patient reported outcomes: breastfeeding self-efficacy (for birthing parent)
To assess breastfeeding self-efficacy, birthing parents will take the 12-item Breastfeeding Self-Efficacy scale. This is scored on a Likert-type scale from 1 - 7 (Strongly Disagree to Strongly Agree). A higher score indicates a better/more positive outcome towards breastfeeding.
Measured: Month 1, 2, 4, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start9 Nov 2022
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Families will be randomized into either the control or intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northwestern University
- Responsible party
- Principal investigator, Emily Miller, Women and Infants Hospital of Rhode Island
- Investigators
- Craig Craig, MD, Study director, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595486
- Sponsor's protocol ID
- STU00216659
- Other IDs
- 1R01HD105499-01
- Status last verified
- Jan 2026
- First submitted
- 5 May 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang E, Lewkowitz AK, Unger JA, Garfield CF, Miller ES. Smartphone Applications to Support Perinatal Mental Health. Obstet Gynecol. 2026 Feb 1;147(2):229-238. doi: 10.1097/AOG.0000000000006139. Epub 2025 Dec 18.
PubMed 41411652Duckworth M, Garfield CF, Santiago JE, Gollan J, O'Sullivan K, Williams D, Lee Y, Muhammad LN, Miller ES. The design and implementation of a multi-center, pragmatic, individual-level randomized controlled trial to evaluate Baby2Home, an mHealth intervention to support new parents. Contemp Clin Trials. 2024 Jul;142:107571. doi: 10.1016/j.cct.2024.107571. Epub 2024 May 11.
PubMed 38740296