ROSE in Sunset Park
ConditionPost Partum Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ROSE Program
Other interventionThe 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.
Treatment groups
308 Participants
are divided into 2 treatment groupsGroup A: Rose Program GroupExperimental treatment 1 intervention
Group B: Comparison GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 1 group session2
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.
Time frame
Week 2 group session3
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.
Time frame
Week 3 group session4
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.
Time frame
Week 4 group sessionSecondary outcomes
1
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.
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)2
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.
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)3
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.
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov