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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sustainment of core program elements

Secondary study objectives

Cost-effectiveness

Depression, Postpartum

ROSE Intervention reach

+1 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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