Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
ROSE
Implementing to Sustain: Determining the Minimum Necessary Intervention to Maintain a Postpartum Depression Prevention Program (ROSE) in Clinics Providing Prenatal Services to Low-income Women
2 other identifiers
interventional
160
1 country
1
Brief Summary
Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedResults Posted
Study results publicly available
April 15, 2026
CompletedApril 15, 2026
March 1, 2026
5.6 years
August 28, 2017
July 17, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion Sustainment of Core Program Elements
Proportion sustainment of ROSE's core program elements, assessed using the ROSE Session-by-Session Adherence Scale, was defined as the mean proportion of core elements delivered that should have been delivered at each ROSE session over the time period (zero if no sessions were completed). Potential range is 0 to 1, higher score reflects better outcome.
Average over months 3, 6, 9, 12, 15, 18, 24, and 30 after baseline
Number of Months of Sustained ROSE Delivery
Number of months when ROSE was delivered was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome.
Summary of total number of months over 30 month study period.
Number of Months of Sustained ROSE Delivery With Fidelity
Number of months when ROSE was delivered with fidelity was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome.
Summary of total number of months over 30 month study period.
Secondary Outcomes (2)
Annualized Percent of Pregnant People Attending at Least One ROSE Session Over 30 Months
Summary over 30 month study period.
Annualized Percent of Pregnant People Attending at Least Three ROSE Sessions (of Five) Over 30 Months
Summary over 30 month study period.
Study Arms (3)
Enhanced implementation as usual (EIAU)
EXPERIMENTALEIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Low-intensity coaching and feedback (LICF)
EXPERIMENTALLow-intensity (every 3 months) coaching and feedback (LICF): Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
High-intensity coaching and feedback (HICF)
EXPERIMENTALHigh-intensity (every month) coaching and feedback (HICF): Enhanced implementation plus high intensity will have received initial training and problem-solving plus planning for sustainment and after that every month will receive one clinical and one operational telephone "booster" meeting.
Interventions
Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,
Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
Eligibility Criteria
You may qualify if:
- outpatient,
- provide prenatal services,
- estimate at least 30% of their pregnant patients received some kind of public assistance (such as federal or state cash assistance, food stamps, subsidized housing, and/or health insurance such as Medicaid),
- have at least 3 new pregnant people per month on average (i.e., enough patient flow to run ROSE), and
- age 18 or older
- someone chosen by the agency to respond to quarterly survey questions about clinical delivery of ROSE (the "clinical respondent");
- someone chosen by the agency to respond to quarterly surveys about operational (billing, scheduling) aspects of ROSE delivery (the "operational respondent," which could be the same or a different person than the "clinical respondent");
- all ROSE facilitators for the agency (who completed self-rated ROSE adherence forms).
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- Butler Hospitalcollaborator
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)collaborator
- Palo Alto Veterans Institute for Researchcollaborator
- University of Rochestercollaborator
- University of Massachusetts, Worcestercollaborator
- Pacific Institute for Research and Evaluationcollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Michigan State University
Flint, Michigan, 48502, United States
Related Publications (2)
Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, Poleshuck E, Simas TAM, Carravallah L, Miller R, Zlotnick C. Outcomes of the ROSE Sustainment (ROSES) Study, a sequential multiple assignment randomized implementation trial to determine the minimum necessary intervention to sustain a postpartum depression prevention program in agencies serving low-income pregnant people. Implement Sci. 2025 Feb 10;20(1):9. doi: 10.1186/s13012-025-01420-z.
PMID: 39930503DERIVEDJohnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, King A, Blume JL, Pham X, Moore Simas TA, Poleshuck E, Weinberg R, Zlotnick C. Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. Implement Sci. 2018 Aug 22;13(1):115. doi: 10.1186/s13012-018-0807-9.
PMID: 30134941DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study period included COVID-19 pandemic with a temporary pause in randomizations.
Results Point of Contact
- Title
- Dr. Jennifer Johnson
- Organization
- Michigan State University
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer E Johnson, Ph.D.
Michigan State University
- STUDY DIRECTOR
Raven Miller, M.A.
Michigan State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- C. S. Mott Endowed Professor of Public Health, Professor of OBGYN, Professor of Psychiatry and Behavioral Medicine
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
June 12, 2018
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
April 15, 2026
Results First Posted
April 15, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After publication of the main results
- Access Criteria
- De-identified data will be made available for scientific inquiry
After data have been collected and study results published, de-identified data will be made available to other qualified researchers upon request, on a CD or other electronic means compatible with our systems. The request will be evaluated by the PIs to ensure that it meets reasonable standards of scientific integrity. We have use standard measures where possible in order to promote data sharing and integration into larger databases and to allow other researchers to analyze the data, including conducting meta-analyses. We will work on the data dictionary throughout the study. Data checking will occur regularly. We will submit primary results for publication by the end of the project period, and will have final de-identified datasets and data dictionaries available by CD within the required time frame.