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NCT03267563 · ClinicalTrials.gov registry record · NA
Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
NCT03267563 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 160 participants.
The verdict
NCT03267563, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
Study Summary
Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechan
Interventions
- BEHAVIORAL EIAU
- BEHAVIORAL LICF
- BEHAVIORAL HICF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03267563
The ClinicalTrials.gov registry entry for NCT03267563 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which EIAU is the first listed.
NCT03267563 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03267563 about?
NCT03267563 is a clinical study titled "Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women". Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenat...
What is the current status of trial NCT03267563?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2018-06-12. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT03267563?
The interventions under investigation include: EIAU (BEHAVIORAL), LICF (BEHAVIORAL), HICF (BEHAVIORAL).
Who is sponsoring clinical trial NCT03267563?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
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