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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum
• Intervention / Treatment: Behavioral: EIAU; Behavioral: LICF; Behavioral: HICF

Detailed Description

A recent expert consensus report concluded that, "Little is known about how well or under what conditions health innovations are sustained and their gains maintained once they are put into practice. Implementation science typically focuses on uptake by early adopters. The later-stage challenges of sustaining evidence-supported interventions receive too little attention." This report placed high priority on conducting return on investment (ROI) studies to determine how much is gained when effective programs are sustained, and cost-benefit trade-offs for effort required to sustain.1 Information is especially needed for preventive behavioral health interventions for adults in outpatient medical (e.g., primary care; OBGYN) settings.

Postpartum depression (PPD) is common and can have serious and lasting consequences for mother and child, including maternal increased risk for suicide, compromised functional status, and adverse infant developmental outcomes. Prevalence of PPD is ~13% in the 12 weeks after childbirth, with rates up to 50% among low-income women, who are especially vulnerable to the consequences of PPD. Outpatient clinics offering prenatal care are an opportune place to deliver PPD prevention services because most women will visit while pregnant. Recent guidelines suggest that prenatal clinics should screen for PPD after birth and refer once it is identified. Unfortunately, prenatal clinics do not routinely do anything to prevent PPD from occurring.

The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is a small-group intervention to prevent PPD that is delivered during pregnancy in outpatient prenatal settings. ROSE is the only PPD preventative intervention that (1) has been found to significantly reduce cases of PPD in multiple randomized trials, and (2) has been tested in community prenatal settings with racially and ethnically diverse low income pregnant women. ROSE consists of four 90-minute group sessions and a 50-minute individual booster session after delivery. Requests for ROSE training in Philadelphia and nationwide in Japan, and recent policy changes supporting payment for comprehensive perinatal services (including behavioral health care) to underserved populations all suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for ROI studies about sustainment efforts and that ROSE is well-positioned for implementation and sustainment research, 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 accross the US. Our conceptual framework comes from RE-AIM and a review on sustainment by Co-I Wiltsey-Stirman,3 with sustainment strategies based on the Replicating Effective Programs (REP) framework. All clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). Clinics will be assessed using surveys and qualitative interviews 9 times over 2.5 years after receiving EIAU. Clinics at risk for failure to sustain operationally (defined as no ROSE intervention in 3 months and none planned) and/or clinically (defined as low fidelity to ROSE core elements) will be randomized to receive additional sustainment support for up to 18 months after baseline. At the first time period at which a clinic is determined to be at risk (i.e., at 3, 6, 9, 12, or 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (EIAU only), or (2) EIAU plus low-intensity (every 3 months) coaching and feedback (LICF). If clinics receiving LICF are still at risk at subsequent monitoring periods, they will be randomized to (1) EIAU + LICF only, or (2) EIAU + LICF + high-intensity (monthly) 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. We will assess costs and benefits of sustainment strategies. Aims are to:

Compare effectiveness of each sustainment step for the following final and proximal OUTCOMES:

1. Sustainment of core program elements at each time point, and total length of time in weeks that: (i) any ROSE services were provided, and (ii) were provided with adequate fidelity to core elements (primary).
2. Health impact (e.g., PPD rates over time at each clinic) and reach (number of patients enrolled in and completing the ROSE program).
3. Return on Investment (costs and cost-effectiveness of each sustainment step).
4. Hypothesized mechanisms include sustainment of: (a) clinical and organizational capacity to deliver core elements, and (b) a sense of engagement/ownership by key clinic staff, Examine predictors and processes to determine which kinds of clinics need which level of support.
5. Explore which clinic characteristics (e.g., organizational and state policy contexts) and hypothesized mechanisms (Aim 4) are associated with best sustainment to determine tailoring variables for choosing/sequencing EIAU, LICF, HICF in the future.
6. Document implementation/sustainment effort processes, their timing relative to desired outcomes, critical incidents to explore factors most related to sustainment after accounting for hypothesized mechanisms.

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. The study will also examine a set of strategies to promote sustainment of an effective PPD prevention intervention for low-income women, reducing negative consequences for mother and child. The proposal directly addresses the goal of PAR-16-238 to conduct longitudinal studies on "factors that contribute to the sustainability of evidence-based interventions," to test strategies to improve quality of care among underserved populations, examine mediators and moderators, and examine cost-effectiveness or other economic outcomes. Thus, the study will advance implementation science, knowledge of implementation science mechanisms, and clinical care for an at-risk population.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • Michigan State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Study enrollment began with enrollment of clinics. Inclusion criteria for clinics were:

1. outpatient,
2. provide prenatal services,
3. 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),
4. have at least 3 new pregnant people per month on average (i.e., enough patient flow to run ROSE), and
5. agree to study procedures. Inclusion criteria were for the clinic itself; once the clinic was included, any pregnant person within the agency could receive ROSE.

Participants were clinic personnel, and they were enrolled within clinic. Their inclusion criteria were:

1. age 18 or older
2. someone chosen by the agency to respond to quarterly survey questions about clinical delivery of ROSE (the "clinical respondent");
3. 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");
4. all ROSE facilitators for the agency (who completed self-rated ROSE adherence forms).

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced implementation as usual (EIAU); EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.	Behavioral: EIAU; Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,; Behavioral: 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.; Behavioral: HICF; Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
Experimental: Low-intensity coaching and feedback (LICF); Low-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.	Behavioral: 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.; Behavioral: HICF; Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
Experimental: High-intensity coaching and feedback (HICF); High-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.	Behavioral: HICF; Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Percent of Pregnant People Attending at Least One ROSE Session Over 30 Months	Surveys at each time point included questions for the clinic to report the number of people who attended at least one ROSE session and the number served by the clinic in the past 12 months. Total numbers attending ROSE over 30 months were annualized (divided by 2.5), then divided by number of pregnant people served in the 12 months prior to baseline and multiplied by 100% to estimate percent of pregnant patients at each agency who received ROSE over 30 months. Potential range is 0 to 100 percent. Higher score reflects better outcome.	Summary over 30 month study period.
Annualized Percent of Pregnant People Attending at Least Three ROSE Sessions (of Five) Over 30 Months	Surveys at each time point included questions for the clinic to report the number of people who attended at least three ROSE sessions and the number served by the clinic in the past 12 months. Total numbers attending at least three ROSE sessions over 30 months were annualized (divided by 2.5), then divided by number of pregnant people served in the 12 months prior to baseline and multiplied by 100% to estimate percent of pregnant patients at each agency who received at least three sessions of ROSE over 30 months. Potential range is 0 to 100 percent. Higher score reflects better outcome.	Summary over 30 month study period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothesized mechanism: Sustainment of clinical and organizational capacity to deliver core elements	Organizational Capacity subscale of the Program Assessment Sustainability Tool (PSAT). Secondary measures of this construct include number of people trained who have time to deliver ROSE and clinic's ability to manage space, scheduling, and reimbursement for ROSE	Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
Hypothesized mechanism: Sustainment of a sense of engagement/ownership by key clinic staff.	The sum of 4 PSAT subscales: Political Support, Partnerships, Communications, and Strategic Planning. The Staff section of the NHS's Sustainability Model and Guide and investment in addressing PPD will be secondary measures	Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: National Institute of Mental Health (NIMH); University of Rochester; University of Massachusetts, Worcester; Butler Hospital; Palo Alto Veterans Institute for Research; Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Pacific Institute for Research and Evaluation
• Investigators: Principal Investigator: Jennifer E Johnson, Ph.D., Michigan State University; Study Director: Raven Miller, M.A., Michigan State University

Publications and helpful links

General Publications

• Johnson 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; prevention; postpartum; implementation; perinatal; sustainment
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: MichiganSUROSE; R01MH130948 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: After publication of the main results
• IPD Sharing Access Criteria: De-identified data will be made available for scientific inquiry
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No