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The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

The ROSE Scale-up Study: Informing a Decision About ROSE as Universal Postpartum Depression Prevention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Three of the 4 ROSE trials included women who were screened for additional risk for PPD per the Cooper survey to maximize trial power."
  • "Scalability as indicated by: (a) cost-outcome comparison of universal vs. indicated prevention (Aim 2); (b) a scalability measure and qualitative interviews with the 98 agencies in the past ROSE implementation trial about how they decided on universal vs. some other kind of prevention and how it went in their settings. 5."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the ROSE program can prevent postpartum depression, or depression after giving birth, in women with different levels of risk. It will help show whether ROSE should be offered to all pregnant women or only those at higher risk. The study is for pregnant women ages 18 and older who receive pregnancy care in the U.S.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Receive pregnancy care in the U.S.
  • Are 12 to 32 weeks pregnant.
  • Speak and understand enough English to understand questions read aloud.
  • Can use a phone you own or one through a friend, relative, or agency.
  • Are willing and able to give names and contact details for at least two people who can help the study team reach you.

Who can't join

  • Currently have a major depressive episode, meaning a period of serious depression.
  • Have ever been diagnosed with bipolar disorder, which causes major mood changes, or a psychotic disorder, which can make it hard to tell what is real.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MI