- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053515
Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication
Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication to Reduce Disparities in Maternal and Child Health
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will examine whether the use of a chatbot to impart health information to minority women during pregnancy and postpartum period improves health care seeking behavior and maternal and infant health outcomes. This study does not involve administration of an investigational intervention and therefore poses minimal risk to participants.
Aim 1: Develop technology for a "chatbot" that will provide health information support to vulnerable mothers the moment they need it.
Aim 2: Evaluate the use of Rosie on maternal and infant outcomes. Aim 3: Release an open-source packet for the construction of a chatbot.
- Participants in the study will be randomly assigned into one of two groups, Rosie the Chatbot group (treatment group) and Book Club group (control group).
- Participants in the Rosie the Chatbot Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will be expected to actively use the chatbot app by asking questions related to maternal and infant health and selecting "thumbs up or thumbs down" to provide feedback for questions' response and use the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).
- Participants in the Book Club Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will receive a monthly children's book, which they are expected to read with baby if parenting or individually if pregnant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
College Park, Maryland, United States, 20742
- University of Maryland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 14 years and older
- Racial minority women
- Pregnant or has an infant < 6 months
- Must be able to read English or Spanish
Exclusion Criteria:
- Mother younger than 14 years of age at time of child's birth.
- Non-hispanic white
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rosie the Chatbot Group
Participants in the Rosie the Chatbot Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey.
In addition, they will be expected to actively use the chatbot app by asking questions related to maternal and infant health and selecting "thumbs up or thumbs down" to provide feedback for questions' response and using the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).
|
Participants in the intervention group will be using the chatbot to ask questions related to the mom and baby's health, provide feedback "selecting thumbs up or thumbs down" on the questions' response, and use the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).
In addition, participants will be taking a pre-test health survey, mid-test health survey, and post-test health survey.
|
|
No Intervention: Book Club Group
Participants in the Book Club Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey.
In addition, they will receive a monthly children's book, which they are expected to read with baby if parenting or individually if pregnant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal postpartum depression
Time Frame: 12 months post randomization
|
The investigators will utilize the Patient Health Questionnaire (PHQ-9) Scale to measure maternal depression.
This scale can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Higher scores indicate worse depression severity.
|
12 months post randomization
|
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Number of emergency room visits
Time Frame: 12 months post randomization
|
The investigators will measure the number of visits to the emergency room.
|
12 months post randomization
|
|
Attendance of well-baby visits (preventive healthcare visits)
Time Frame: 12 months post randomization
|
The investigators will measure the number of well-baby visits.
|
12 months post randomization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Quynh C Nguyen, PhD, University of Maryland
- Principal Investigator: Elizabeth M Aparicio, PhD, LCSW-C, University of Maryland
Publications and helpful links
General Publications
- Mane HY, Channell Doig A, Marin Gutierrez FX, Jasczynski M, Yue X, Srikanth NP, Mane S, Sun A, Moats RA, Patel P, He X, Boyd-Graber JL, Aparicio EM, Nguyen QC. Practical Guidance for the Development of Rosie, a Health Education Question-and-Answer Chatbot for New Mothers. J Public Health Manag Pract. 2023 Sep-Oct 01;29(5):663-670. doi: 10.1097/PHH.0000000000001781.
- Peters CJ, Aldana Lainez V, Clark K, Jasczynski M, Nguyen QC, Norell EM. Using an AI-powered Mobile Application Chatbot to Address Maternal Depression Indicators and Inquiries in the Perinatal and Postpartum Periods: A Multimethod Analysis. Inquiry. 2026 Jan-Dec;63:469580261417580. doi: 10.1177/00469580261417580. Epub 2026 Jan 29.
- Nguyen QC, Norell EM, Mane H, Yue X, Srikanth NP, Peters CJ, Gutierrez FXM, Kurella E, Dipankar P, Salazar D, Mullaputi PSP, Alibilli A, Santhosh A, He X, Boyd-Graber J, Nguyen TT. Developing an artificial intelligence-powered question-and-answer chatbot with English-Spanish capabilities for new mothers. JAMIA Open. 2026 Jan 6;9(1):ooaf169. doi: 10.1093/jamiaopen/ooaf169. eCollection 2026 Feb.
- Nguyen QC, Aparicio EM, Jasczynski M, Channell Doig A, Yue X, Mane H, Srikanth N, Gutierrez FXM, Delcid N, He X, Boyd-Graber J. Rosie, a Health Education Question-and-Answer Chatbot for New Mothers: Randomized Pilot Study. JMIR Form Res. 2024 Jan 12;8:e51361. doi: 10.2196/51361.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MD016037-03 (U.S. NIH Grant/Contract)
- 3R01MD016037-03S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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