No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
2,320 (estimated)
Sponsor
Michigan State University · Other
Who this trial is looking for
This trial is looking for women who are pregnant and receiving prenatal care in the U.S. It involves participating in the ROSE program, which aims to prevent postpartum depression.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 18 or older
I am receiving prenatal services within the U.S
I am between 12-32 weeks pregnant
I can understand English well enough to follow along with questionnaires
I have access to a telephone
I am willing to provide contact information for two people who can locate me
You may not be able to join if
I have a current major depressive episode
I have a current or past diagnosis of bipolar disorder
I have a current or past diagnosis of a psychotic disorder
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 …
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.
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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…
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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