ROSE in Sunset Park

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04940585
Status
Recruiting
Apply to this trial

Conditions

  • Post Partum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • ROSE Program — OTHER
    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 Details

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.

Key Dates

Start date
Mar 21, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
308 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Acceptability of the ROSE intervention [ Time Frame: Week 1 group session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Bonnie Kerker, PhD
[email protected]
646-501-9896
Bonnie Kerker, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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