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Behavioral Intervention

ROSE Program for Preventing Postpartum Depression (PPD-ACE Trial)

N/A

Recruiting

Research Sponsored by Northwestern 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 up to 6 months postpartum

Awards & highlights

PPD-ACE Trial Summary

This trial will study if an intervention called ROSE can help people with childhood trauma reduce the risk of depression during pregnancy. Participants will be asked to report how they feel every 4 weeks.

Who is the study for?

This trial is for pregnant individuals over 18, with a history of adverse childhood experiences (ACE score ≥ 2), who are less than 24 weeks into a non-anomalous, single pregnancy. They must plan to deliver at Prentice Women's Hospital and not be currently experiencing major depression or substance use disorders.Check my eligibility

What is being tested?

The study tests the ROSE program against enhanced usual care in preventing perinatal depression among those with difficult childhoods. Participants will receive either standard care or the ROSE intervention and report their depressive symptoms every four weeks.See study design

What are the potential side effects?

Since ROSE involves psychological support and education, side effects may include emotional discomfort during discussions about personal experiences but no physical side effects are expected from this type of intervention.

PPD-ACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depression symptoms

Perinatal depression

Secondary outcome measures

Anxiety symptoms

Attachment in adult relationships

Breastfeeding self-efficacy scale

+6 more

PPD-ACE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ROSE interventionExperimental Treatment1 Intervention

Those randomized to the intervention will be offered 4 group-based prenatal sessions and one individual postpartum "booster" session guided by the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program embedded within the collaborative care model. Participants will be followed with monthly self-reported screens for depression, and those identified to have incident depression symptoms will receive treatment within the collaborative care model.

Group II: Enhanced treatment as usualActive Control1 Intervention

Those randomized to enhanced treatment as usual will receive brief psychoeducation about perinatal depression and the associations between ACEs and perinatal depression. Information about the collaborative care program will be provided. Individuals will be followed with monthly self-reported screens for depression, without any prevention programming for perinatal depression. Those identified to have incident depression symptoms will receive recommendations for treatment within the collaborative care model.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,011 Total Patients Enrolled

8 Trials studying Postpartum Depression

2,050 Patients Enrolled for Postpartum Depression

Women and Infants Hospital of Rhode IslandOTHER

109 Previous Clinical Trials

38,524 Total Patients Enrolled

4 Trials studying Postpartum Depression

1,112 Patients Enrolled for Postpartum Depression

Media Library

ROSE Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05795114 — N/A

Postpartum Depression Research Study Groups: Enhanced treatment as usual, ROSE intervention

Postpartum Depression Clinical Trial 2023: ROSE Program Highlights & Side Effects. Trial Name: NCT05795114 — N/A

ROSE Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05795114 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for enrolment in this medical trial?

"According to clinicaltrials.gov, this medical study is currently searching for volunteers to join their trial which was initially posted on the 20th of July, 2023 and recently updated four days later."

Answered by AI

What is the current participant count for this medical experiment?

"Indeed, the information accessible on clinicaltrials.gov delineates that this medical study is actively enrolling patients. Initially posted in July 20th of 2021, it was most recently updated four days later; currently searching for 76 participants from one site."

Answered by AI

What is the primary purpose of this investigation?

"The objective of this clinical trial, which will be evaluated over a period of 6 months after delivery, is to assess the impact on depression symptoms. As secondary outcomes, investigators are looking at self-efficacy (using PROMIS), breastfeeding efficacy (via a specific scale) and anxiety symptom trajectories through GAD-7 screens given every 4 weeks until the end of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Emily Miller 2023. "Perinatal Depression and Adverse Childhood Experiences: Prevention Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05795114.

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