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

RecruitingNAAges 18 Years - anyFemaleMichigan State University
NCT05700760 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 agenc

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📋 Eligibility rules (as published)
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
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What it tests

  • ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)
  • Enhanced Care as Usual (CAU)
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Where

1 site
Michigan State University
Flint, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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