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ROSE Program Sustainment for Postpartum Depression (ROSE Trial)

N/A
Waitlist Available
Led By Jennifer E Johnson, Ph.D.
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
Awards & highlights

ROSE Trial Summary

This trial will study the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE, an intervention to prevent postpartum depression, in outpatient prenatal clinics.

Who is the study for?
This trial is for outpatient prenatal clinics that see at least 10 new pregnant women per month, where over half of the patients receive public assistance. Clinics must agree to study procedures to participate.Check my eligibility
What is being tested?
The trial tests a program called ROSE aimed at preventing postpartum depression. It uses a stepwise approach with varying levels of coaching and feedback to help clinics sustain the program effectively.See study design
What are the potential side effects?
Since this is an implementation study rather than a drug trial, it doesn't have side effects in the traditional sense. The focus is on evaluating the effectiveness and cost-effectiveness of sustaining mental health support programs.

ROSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sustainment of core program elements
Secondary outcome measures
Cost-effectiveness
Depression, Postpartum
ROSE Intervention reach
+1 more
Other outcome measures
Hypothesized mechanism: Sustainment of a sense of engagement/ownership by key clinic staff.
Hypothesized mechanism: Sustainment of clinical and organizational capacity to deliver core elements

ROSE Trial Design

3Treatment groups
Experimental Treatment
Group I: Low-intensity coaching and feedbackExperimental Treatment2 Interventions
Clinics will receive enhanced implementation as usual (EIAU) plus low-intensity (every 3 months) implementation coaching and feedback (LICF). LICF consists of quarterly clinical and operational coaching and feedback calls, as well as quarterly participation in an implementation collaborative board.
Group II: High-intensity coaching and feedbackExperimental Treatment3 Interventions
Clinics will receive enhanced implementation as usual (EIAU) plus high-intensity (every month) implementation coaching and feedback (HICF). HICF consists of monthly clinical and operational coaching and feedback calls, monthly participation in an implementation collaborative board, and on call technical assistance.
Group III: Enhanced implementation as usual (EIAU)Experimental Treatment1 Intervention
All clinics will receive enhanced implementation as usual (EIAU) that is initial clinical and operational training + tools for sustainment. This occurs once at the beginning of the trial.

Find a Location

Who is running the clinical trial?

Palo Alto Veterans Institute for ResearchOTHER
52 Previous Clinical Trials
7,105 Total Patients Enrolled
Pacific Institute for Research and EvaluationOTHER
26 Previous Clinical Trials
33,414 Total Patients Enrolled
2 Trials studying Postpartum Depression
2,570 Patients Enrolled for Postpartum Depression
University of Massachusetts, WorcesterOTHER
342 Previous Clinical Trials
975,810 Total Patients Enrolled

Media Library

HICF Clinical Trial Eligibility Overview. Trial Name: NCT03267563 — N/A
Postpartum Depression Research Study Groups: Low-intensity coaching and feedback, High-intensity coaching and feedback, Enhanced implementation as usual (EIAU)
Postpartum Depression Clinical Trial 2023: HICF Highlights & Side Effects. Trial Name: NCT03267563 — N/A
HICF 2023 Treatment Timeline for Medical Study. Trial Name: NCT03267563 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Implementation ScienceJournal
Protocol for the ROSE Sustainment (ROSES) Study, a Sequential Multiple Assignment Randomized Trial to Determine the Minimum Necessary Intervention to Maintain a Postpartum Depression Prevention Program in Prenatal Clinics Serving Low-income Women
Johnson, Jennifer E., Shannon Wiltsey-Stirman, Alla Sikorskii, Ted Miller, Amanda King, Jennifer L. Blume, Xuan Pham, et al.. 2018. “Protocol for the ROSE Sustainment (ROSES) Study, a Sequential Multiple Assignment Randomized Trial to Determine the Minimum Necessary Intervention to Maintain a Postpartum Depression Prevention Program in Prenatal Clinics Serving Low-income Women”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-018-0807-9.
clinicaltrials.govStudy
Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
Jennifer E. Johnson 2018. "Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03267563.
~117 spots leftby Apr 2025
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