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Recruiting

NCT Number: NCT04940585

ROSE in Sunset Park

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.

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Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Bonnie Kerker, MD

PRINCIPAL_INVESTIGATOR

Bonnie Kerker, PhD

CONTACT

[email protected]

646-501-9896

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of the ROSE intervention

    Time frame: Week 1 group session

    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.

  2. Acceptability of the ROSE intervention

    Time frame: Week 2 group session

    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.

  3. Acceptability of the ROSE intervention

    Time frame: Week 3 group session

    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.

  4. Acceptability of the ROSE intervention

    Time frame: Week 4 group session

    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.

  5. Acceptability of the ROSE intervention

    Time frame: Week 5 group session

    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.

  6. Acceptability of the ROSE intervention

    Time frame: Week 6 group session

    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.

  7. Acceptability of the ROSE intervention

    Time frame: Post-birth Visit (4-5 weeks after birth)

    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.

  8. Change in level of postpartum depression

    Time frame: 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 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.

Secondary outcomes

  1. Change in the level of self-efficacy

    Time frame: 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 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.

  2. Change in perceived social support

    Time frame: 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)

    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.

  3. Change in perception of stress

    Time frame: 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana Zeller

CONTACT

[email protected]

646-951-6568

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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