ROSE in Sunset Park

NYU Langone Health

Status: Active, not recruiting

Conditions: Post Partum Depression

Treatments: Other: ROSE Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04940585

19-01961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Rose Program Group

Experimental group

Description:

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.

Treatment:

Other: ROSE Program

Comparison Group

No Intervention group

Description:

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