Recruiting

ROSE

Sponsor:

NYU Langone Health

Code:

NCT04940585

Conditions

Post Partum Depression

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

ROSE Program

Study Details

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.

Conditions

Post Partum Depression

Study ID

NCT04940585

Start date

Mar 21, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

308 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Comparison Group

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

Interventions

ROSE Program

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.

Primary outcome measure

  • Acceptability of the ROSE intervention [ Time Frame: Week 1 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Week 2 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Week 3 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Week 4 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Week 5 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Week 6 group session ]
  • Acceptability of the ROSE intervention [ Time Frame: Post-birth Visit (4-5 weeks after birth) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Juliana Zeller

646-951-6568Juliana.Zeller@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Bonnie Kerker, PhD

646-501-9896bonnie.kerker@nyulangone.org

Principal Investigator:

Bonnie Kerker, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-30.