ROSE in Sunset Park

NCT04940585 | Recruiting DMC

• 1 other identifier: 19-01961
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum Depression

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Change in the level of self-efficacy

  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

  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

  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)

Study Arms (2)

Rose Program Group

EXPERIMENTAL

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

Comparison Group

NO INTERVENTION

Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma.

Interventions

ROSE Program OTHER

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.

Rose Program Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Bonnie Kerker, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Zeller

CONTACT

646-951-6568; Juliana.Zeller@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: June 25, 2021
• Study Start: March 21, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request

Locations

US (1)