Recruiting

ROSE

Sponsor:

Michigan State University

Code:

NCT05700760

Conditions

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)

Enhanced Care as Usual (CAU)

Study Details

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.

Conditions

Postpartum Depression

Study ID

NCT05700760

Start date

Jun 1, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Is aged 18 or older
2. Is receiving prenatal services within the U.S
3. Is between 12-32 weeks pregnant
4. Speaks and understand English well enough to understand questionnaires when they are read aloud
5. Has access to a telephone through owning one, a relative/friend, or an agency
6. Is willing and able to provide the name and contact information of at least two locator persons

Exclusion Criteria:

1. Has a current major depressive episode
2. Has current or past diagnosis of a bipolar disorder or a psychotic disorder

Study Design

Enrollment

2320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)

Evidence-based 5 session psychosocial intervention that has been found to prevent \~50% of postpartum depression among low-income, at risk women.

active comparator: Enhanced Care as Usual (CAU)

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.

Interventions

ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)

Evidence-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)

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.

Primary outcome measure

  • SCID-5 Major Depressive Episode [ Time Frame: through 6 months after birth ]

Central Contacts and Locations

Central contacts

Jennifer E Johnson, PhD

810-600-5669jjohns@msu.edu

Locations

Michigan State University

Recruiting

Flint, Michigan, United States, 48502

Contacts

Jennifer Johnson, PhD

jjohns@msu.edu

Christine Huff, MBA

huffchr5@msu.edu

More Information

Sponsor

Michigan State University

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • postpartum depression
  • antenatal depression
  • depression
  • prevention
  • depression prevention
  • pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michigan State University on 2026-05-18.