Program to support new mothers 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
This study is testing a program to see if it can help new mothers in Sunset Park feel less stressed and depressed after having a baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04940585 on ClinicalTrials.gov |
What this trial studies
This study evaluates the ROSE program, aimed at preventing and reducing postpartum depression among pregnant women. It consists of two phases: the first phase assesses the feasibility and acceptability of the intervention, while the second phase measures its effectiveness in decreasing maternal stress and depressive symptoms. Participants will receive support and resources to enhance their social support and self-efficacy during the transition to motherhood. The study is conducted at a prenatal clinic in Sunset Park, Brooklyn.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in their second trimester receiving prenatal care at the Sunset Park Family Health Center who are at risk for postpartum depression.
Not a fit: Patients who are not receiving prenatal care at the designated health center or who do not meet the specific criteria for depression risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mental health outcomes for new mothers by reducing postpartum depression and enhancing social support.
How similar studies have performed: Other studies have shown promising results with similar interventions aimed at reducing postpartum depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Bonnie Kerker, PhD — NYU Langone Health
- Study coordinator: Juliana Zeller
- Email: Juliana.Zeller@nyulangone.org
- Phone: 646-951-6568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.