Evidence map›Paper›PMID 37473848›Full record

ArticleContemporary clinical trials2023

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.

Jennifer E Johnson, Amy M Loree, Alla Sikorskii, Ted R Miller, Laura Carravallah, Brandon Taylor, Caron Zlotnick

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jennifer E JohnsonCharles Stewart Mott Department of Public Health, Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48502, United States of America. Electronic address: JJohns@msu.edu.
Amy M LoreeCenter for Health Policy & Health Services Research, Henry Ford Health, 1 Ford Place, Suite 5E, Detroit, MI 48220, United States of America. Electronic address: aloree1@hfhs.org.
Alla SikorskiiDepartment of Psychiatry, Michigan State University College of Osteopathic Medicine, 909 Wilson Rd, East Lansing, MI 48824, United States of America. Electronic address: Sikorska@msu.edu.
Ted R MillerPacific Institute for Research and Evaluation, 11720 Beltsville Drive Suite 900, Calverton, MD 20705, United States of America. Electronic address: Miller@pire.org.
Laura CarravallahDepartment of Pediatrics and Human Development, Michigan State University College of Human Medicine, 200 East 1(st) St, Flint, MI 48502, United States of America. Electronic address: Carraval@msu.edu.
Brandon TaylorCharles Stewart Mott Department of Public Health, Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48502, United States of America. Electronic address: Tayl1214@msu.edu.
Caron ZlotnickButler Hospital and Women and Infants Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America; University of Cape Town, Cape Town, South Africa. Electronic address: Caron_Zlotnick@brown.edu.

Funding

The ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression preventionR01MH130948 · NIMH · MICHIGAN STATE UNIVERSITY · PI JENNIFER E JOHNSON, CARON ZLOTNICK · 2022 to 2026
$6.2M
Implementing to sustain: Determining the minimum necessary intervention to maintain a postpartum depression prevention program (ROSE) in clinics providing prenatal services to low-income womenR01MH114883 · NIMH · MICHIGAN STATE UNIVERSITY · PI JOHNSON, JENNIFER E, ZLOTNICK, CARON · 2018 to 2022
$3.6M
NIMH NIH HHS R01 MH114883NIMH NIH HHS R01 MH130948
6 · The paper itself

Abstract

purposeTo examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention.

backgroundThe United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial.

designEffectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated).

conclusionThis will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.

Indexed as

Depression, PostpartumCost-Benefit AnalysisFemaleHumansInfant, NewbornMothersPregnancyPreventive Health ServicesResearch DesignUnited StatesClinical trial protocolHealth equityImplementation sciencePostpartum depressionPragmatic trialsPreventionScale-up

Identifiers

PMID37473848
PMCPMC10528027

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.