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Behavioural Intervention
Baby2Home Mobile Application for Mental Health Wellness
N/A
Recruiting
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years old or greater
Viable term infant (≥ 37 weeks)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 1 year postpartum
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a mobile application rather than medication or medical procedures, traditional side effects are not applicable. However, users may experience issues related to app usability or increased screen time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My baby was born at or after 37 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 1 year postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 1 year postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of preventive health services utilization for all family members (birthing, non-birthing, and infant)
Secondary outcome measures
Anxiety symptoms (for birthing and non-birthing parent)
Breastfeeding self-efficacy (for birthing parent)
COVID-19 related impact (for birthing and non-birthing parent)
+15 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Baby2Home InterventionExperimental Treatment1 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 CareActive Control1 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.
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Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
109 Previous Clinical Trials
37,960 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,090 Total Patients Enrolled
1 Trials studying Health Literacy
355 Patients Enrolled for Health Literacy
Craig Craig, MDStudy DirectorLurie Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a working email address.I am 18 years old or older.My baby was born at or after 37 weeks of pregnancy.Babies who have passed away.My infant needs to be admitted to the NICU.I speak English.You have a history of intimate partner violence with your current partner, and this may exclude your partner from participating in the study.I currently have a COVID-19 infection without recovery.One or both of your parents have a serious mental illness like bipolar disorder or schizophrenia.This study is only open to people who have had their first child.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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