Clinical trial NCT04940585: ROSE in Sunset Park
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Depression
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Acceptability of the ROSE intervention
timeFrame: Week 1 group session
measure: Acceptability of the ROSE intervention
timeFrame: Week 2 group session
measure: Acceptability of the ROSE intervention
timeFrame: Week 3 group session
measure: Acceptability of the ROSE intervention
timeFrame: Week 4 group session
measure: Acceptability of the ROSE intervention
timeFrame: Week 5 group session
measure: Acceptability of the ROSE intervention
timeFrame: Week 6 group session
measure: Acceptability of the ROSE intervention
timeFrame: Post-birth Visit (4-5 weeks after birth)
measure: Change in level of postpartum depression
timeFrame: 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 outcomes:
measure: Change in the level of self-efficacy
timeFrame: 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)
measure: Change in perceived social support
timeFrame: 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)
measure: Change in perception of stress
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bonnie Kerker, PhD
role: PRINCIPAL_INVESTIGATOR
References: