Post Partum DepressionNCT04940585
ROSE in Sunset Park
A study testing ROSE Program in people with Post Partum Depression, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- ROSE Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Bonnie Kerker, PhD, 646-501-9896, bonnie.kerker@nyulangone.org
Bonnie Kerker, MD
About this study
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
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.
Read the 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
- Post Partum Depression
- Being tested
- ROSE Program
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rose Program Group | Experimental | 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. Receives: Other: ROSE Program |
| Comparison Group | No intervention | Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the ROSE intervention
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.
Measured: Week 1 group session
Acceptability of the ROSE intervention
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.
Measured: Week 2 group session
Acceptability of the ROSE intervention
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.
Measured: Week 3 group session
Acceptability of the ROSE intervention
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.
Measured: Week 4 group session
Acceptability of the ROSE intervention
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.
Measured: Week 5 group session
Acceptability of the ROSE intervention
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.
Measured: Week 6 group session
Acceptability of the ROSE intervention
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.
Measured: Post-birth Visit (4-5 weeks after birth)
Change in level of postpartum depression
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.
Measured: 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 (3)
Change in the level of self-efficacy
This will be measured by using the General Self-Efficacy Scale (GSE). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
Measured: 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 perceived social support
The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief questionnaire designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale.
Measured: 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
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes a number of direct queries about current levels of experienced stress.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start21 Mar 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonnie Kerker, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940585
- Sponsor's protocol ID
- 19-01961
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04940585
- Acronym / sponsor ID
- 19-01961
- Conditions
- Post Partum Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rose Program Group | Experimental | Other: ROSE ProgramROSE 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. |
| Comparison Group | No intervention | –Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROSE ProgramThe 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. | Other | Rose Program Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in the level of self-efficacy
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)
Change in perceived social support
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)
Change in perception of stress
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bonnie Kerker, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSE Program in people with Post Partum Depression, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana Zeller (646-951-6568, Juliana.Zeller@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the ROSE intervention (time frame: Week 1 group session). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.