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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 308
- Locations
- 1
- Primary Endpoint
- Change in level of postpartum depression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
- •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
Arms & Interventions
Rose Program Group
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.
Intervention: ROSE Program (Other)
Comparison Group
Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma.
Outcomes
Primary Outcomes
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)
This will be measured by the Edinburgh Postnatal Depression Scale (EPDS) which is a 10-item questionnaire. Mothers are asked to answer each question in terms of the past seven days. Mothers scoring above 12 or 13 are likely to be suffering from depression and should seek medical attention.
Acceptability of the ROSE intervention
Time Frame: Post-birth Visit (4-5 weeks after birth)
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 1 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 2 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 3 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 4 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 5 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Acceptability of the ROSE intervention
Time Frame: Week 6 group session
This will be measured by the client Satisfaction Questionnaire which is an 8-item questionnaire designed to assess the participant's satisfaction with a health service.
Secondary Outcomes
- Change in perceived social support(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 the level of self-efficacy(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(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))