ROSE in Sunset Park

Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE), a Study of a Postpartum Depression Prevention Intervention Among Pregnant Women in a Women's Health Clinic

The purpose of this study is to learn more about pregnant women's' experience with Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) and to evaluate the effectiveness of the ROSE program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.

Study Overview

• Status: Recruiting
• Conditions: Post Partum Depression
• Intervention / Treatment: Other: ROSE Program

Detailed Description

This is a 2-phase study, including a feasibility phase (Pilot, Phase 1), and an outcomes evaluation phase (Phase 2). Phase 1 tests the acceptability and feasibility of a postpartum depression prevention intervention among pregnant women attending a prenatal clinic in Sunset Park, Brooklyn. NYU research staff will be trained to implement this intervention. Based on the feedback received from women and staff in phase 1, the intervention will be modified accordingly. Phase 2 will be an outcomes evaluation to test the effectiveness of the intervention to decrease maternal stress and depressive symptoms, and increase perceived social support and self-efficacy among new mothers.

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana Zeller; Phone Number: 646-951-6568; Email: Juliana.Zeller@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Bonnie Kerker, PhD; Phone Number: 646-501-9896; Email: bonnie.kerker@nyulangone.org
      • Principal Investigator: Bonnie Kerker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
• Female
• At least 18 years of age
• Speaks and understands English or Spanish (depending on the language of the next group)
• Is pregnant
• Is in the second trimester of her pregnancy
• Capable of providing informed consent.
• Scores between 4 and 12 on Edinburgh Postnatal Depression Scale or records 2 or more ACEs on adapted ACEs questionnaire

Exclusion Criteria:

• Not receiving prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
• Not female
• Under18 years of age
• Does not speak and understand English or Spanish
• Is not pregnant
• Is not in the second trimester of her pregnancy
• Is not capable of providing informed consent.
• Scoring < 4or >12 on Edinburgh Postnatal Depression Scale and scores 1 or less on adapted ACEs questionnaire.
• Positive score to #10 on the Edinburgh Postnatal Depression Scale

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rose Program Group; 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.	Other: ROSE Program; The program includes 6 group sessions and an individual session 4-6 weeks after birth. Each session will last 60 minutes and will be conducted over Webex. The key areas that will be discussed during the sessions include: Psychoeducation, Adjusting to life with baby, Effective communication, Asking for what you need, and Planning for the future.
No Intervention: Comparison Group; Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 1 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 2 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 3 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 4 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 5 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Week 6 group session
Acceptability of the ROSE intervention	This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.	Post-birth Visit (4-5 weeks after birth)
Change in level of postpartum depression	This will be measured by the Edinburgh Postnatal Depression Scale (EPDS) which is a 10-item questionnaire. Mothers are asked to answer each question in terms of the past seven days. Mothers scoring above 12 or 13 are likely to be suffering from depression and should seek medical attention.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of self-efficacy	This will be measured by using the General Self-Efficacy Scale (GSE). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.	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)
Change in perceived social support	The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief questionnaire designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale.	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)
Change in perception of stress	The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes a number of direct queries about current levels of experienced stress.	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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Bonnie Kerker, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 19-01961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No