Trials / Recruiting
RecruitingNCT04940585
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 308 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-03-21
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2021-06-25
- Last updated
- 2026-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04940585. Inclusion in this directory is not an endorsement.