The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention
ROSES-II
2 other identifiers
interventional
2,320
1 country
1
Brief Summary
The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.
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 2023
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
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 18, 2026
May 1, 2026
4.6 years
January 17, 2023
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SCID-5 Major Depressive Episode
The SCID is the gold standard diagnostic assessment of major depressive episode.
through 6 months after birth
Secondary Outcomes (1)
SF-12
Baseline (during pregnancy and 6 months after birth)
Study Arms (2)
ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)
EXPERIMENTALEvidence-based 5 session psychosocial intervention that has been found to prevent \~50% of postpartum depression among low-income, at risk women.
Enhanced Care as Usual (CAU)
ACTIVE COMPARATORUsual care at the study site does not include postpartum depression prevention. Instead, HFHS clinics try to screen for PPD that has already occurred and refer women for mental health care. Screening for existing PPD at these clinics primarily relies on the EPDS (10+), Perinatal women who score 10+ on the EPDS are referred for mental health services. Services received depends on follow-up, severity, and the mental health wait list. Our study will exclude women meeting criteria for likely current major depressive episode at baseline and assist them in obtaining mental health care. Enhanced CAU consists of usual care + monitoring and emergency referral, as is required to fulfill ethical obligations to trial participants.
Interventions
Usual care at the study site does not include postpartum depression prevention. Instead, HFHS clinics try to screen for PPD that has already occurred and refer women for mental health care. Screening for existing PPD at these clinics primarily relies on the EPDS (10+), Perinatal women who score 10+ on the EPDS are referred for mental health services. Services received depends on follow-up, severity, and the mental health wait list. Our study will exclude women meeting criteria for likely current major depressive episode at baseline and assist them in obtaining mental health care. Enhanced CAU consists of usual care + monitoring and emergency referral, as is required to fulfill ethical obligations to trial participants.
Evidence-based 5 session psychosocial intervention that has been found to prevent \~50% of postpartum depression among low-income, at risk women.
Eligibility Criteria
You may qualify if:
- Is aged 18 or older
- Is receiving prenatal services within the U.S
- Is between 12-32 weeks pregnant
- Speaks and understand English well enough to understand questionnaires when they are read aloud
- Has access to a telephone through owning one, a relative/friend, or an agency
- Is willing and able to provide the name and contact information of at least two locator persons
You may not qualify if:
- Has a current major depressive episode
- Has current or past diagnosis of a bipolar disorder or a psychotic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- Henry Ford Health Systemcollaborator
- Butler Hospitalcollaborator
- Pacific Institute for Research and Evaluationcollaborator
Study Sites (1)
Michigan State University
Flint, Michigan, 48502, United States
Related Publications (1)
Johnson JE, Loree AM, Sikorskii A, Miller TR, Carravallah L, Taylor B, Zlotnick C. Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. Contemp Clin Trials. 2023 Sep;132:107297. doi: 10.1016/j.cct.2023.107297. Epub 2023 Jul 18.
PMID: 37473848DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer E Johnson, PhD
Michigan State University
- PRINCIPAL INVESTIGATOR
Caron Zlotnick, PhD
Butler Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research assistants will randomize participants to a study arm. The participant will be assigned to a new research assistant for the follow-up assessment, who is masked from the study arm.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- C. S. Mott Endowed Professor of Public Health
Study Record Dates
First Submitted
January 17, 2023
First Posted
January 26, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data sharing will occur on NIH-designated timelines.
- Access Criteria
- Participant data will be shared to the National Institute of Mental Health Data Archive (NDA).
Participant data will be shared to the National Institute of Mental Health Data Archive (NDA).