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ROSE Program for Postpartum Depression

N/A
Waitlist Available
Led By Bonnie Kerker, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
At least 18 years of age
Must not have
Not female
Under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-birth visit (4-5 weeks after birth)
Awards & highlights

Summary

This trial will evaluate the effectiveness of the ROSE program in helping pregnant women with post-partum depression, stress, and social support.

Who is the study for?
This trial is for pregnant women at least 18 years old in their second trimester receiving care at the Sunset Park Family Health Center. Participants must understand English or Spanish, be able to consent, and have mild depressive symptoms as indicated by a score of 4-12 on the Edinburgh Postnatal Depression Scale or record two or more ACEs.
What is being tested?
The ROSE Program is being tested for its effectiveness in preventing and reducing postpartum depression symptoms, decreasing stress levels, and increasing social support among pregnant women during their prenatal period.
What are the potential side effects?
Since the ROSE Program involves non-medical interventions such as education and support, traditional side effects associated with medications are not expected. However, participants may experience emotional discomfort discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not female.
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I am under 18 years old.
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I cannot speak or understand English or Spanish.
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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, week 1 group session, week 2 group session, week 3 group session, week 4 group session, week 5 group session,week 6 group session,, post-birth visit (4-5 weeks after birth)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit, week 1 group session, week 2 group session, week 3 group session, week 4 group session, week 5 group session,week 6 group session,, post-birth visit (4-5 weeks after birth) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the ROSE intervention
Change in level of postpartum depression
Secondary study objectives
Change in perceived social support
Change in perception of stress
Change in the level of self-efficacy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rose Program GroupExperimental Treatment1 Intervention
ROSE is a 7-session intervention. Participants will attend 6 weekly group sessions virtually, through a program on the computer called WebEx or at the clinic, and then one individual session after delivery. Participants will complete a few questionnaires at three different timepoints, including demographics, stress, social support, physical and mental health, and trauma.
Group II: Comparison GroupActive Control1 Intervention
Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,791 Total Patients Enrolled
1 Trials studying Postpartum Depression
Bonnie Kerker, PhDPrincipal InvestigatorNYU Langone Health
~18 spots leftby Aug 2026
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