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PregnancyNCT06053515

Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

A study testing Rosie the Chatbot in people with Pregnancy and Postpartum Depression, run by University of Maryland, College Park at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Read more about this study

Who is it for?
Ages 14 to 99 years, women onlyHealthy volunteers can take part
What is being tested?
Rosie the Chatbot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
13 Oct 2023to 23 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 14 to 99 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age 14 years and older
  • Racial minority women
  • Pregnant or has an infant < 6 months
  • Must be able to read English or Spanish

Who cannot join

  • Mother younger than 14 years of age at time of child's birth.
  • Non-hispanic white

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland

    College Park, Maryland, 20742

Other trials in United States

About this study

Official title: Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication to Reduce Disparities in Maternal and Child Health

Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.

Read the 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.
Being tested
Rosie the Chatbot
Keywords
chatbot, health information, racial/ethnic health disparities, maternal and child health, artificial intelligence, question-answering models
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosie the ChatbotBehavioural

    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.

Study groups in NCT06053515
Study groupRoleWhat they receive
Rosie the Chatbot GroupExperimentalParticipants 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).
Receives: Behavioral: Rosie the Chatbot
Book Club GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal postpartum depression

    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.

    Measured: 12 months post randomization

  2. Number of emergency room visits

    The investigators will measure the number of visits to the emergency room.

    Measured: 12 months post randomization

  3. Attendance of well-baby visits (preventive healthcare visits)

    The investigators will measure the number of well-baby visits.

    Measured: 12 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start13 Oct 2023
  3. Primary completion23 Jan 2026
  4. Study completion23 Jan 2026

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053515
Sponsor's protocol ID
5R01MD016037-03
Other IDs
5R01MD016037-03, 3R01MD016037-03S1
Status last verified
Apr 2024
First submitted
15 Sep 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37478093

  • Norell EM, Yue X, Mane H, Marin Gutierrez FX, Srikanth NP, Smolyak D, Dipankar P, Peters CJ, Boyd-Graber J, Nguyen TT, He X, Nguyen QC. Generative Artificial Intelligence and Maternal Health Outcomes in Pregnant and Postpartum Individuals: A Randomized Clinical Trial. JAMA Netw Open. 2026 Nov 2;9(11):e2641062. doi: 10.1001/jamanetworkopen.2026.41062.

    PubMed 42981095

  • 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.

    PubMed 41607314

  • 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.

    PubMed 41502532

  • 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.

    PubMed 38214963

Questions about this trial

What is this clinical trial studying?

A study testing Rosie the Chatbot in people with Pregnancy and Postpartum Depression, run by University of Maryland, College Park at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal postpartum depression (time frame: 12 months post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06053515, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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