ROSE in Sunset Park
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ROSE Program.
- Who it may be relevant to
- Registry conditions: Post Partum Depression. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Acceptability of the ROSE intervention [Time frame: Week 1 group session]
- Acceptability of the ROSE intervention [Time frame: Week 2 group session]
- Acceptability of the ROSE intervention [Time frame: Week 3 group session]
- Acceptability of the ROSE intervention [Time frame: Week 4 group session]
- Acceptability of the ROSE intervention [Time frame: Week 5 group session]
- Acceptability of the ROSE intervention [Time frame: Week 6 group session]
- Acceptability of the ROSE intervention [Time frame: Post-birth Visit (4-5 weeks after birth)]
- 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)]
Secondary outcome measures (3)
- 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)]
- 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)]
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT04940585 · 19-01961