RecruitingNot Applicable

ROSE in Sunset Park

United States308 participantsStarted 2021-03-21

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Acceptability of the ROSE intervention

Timeframe: Week 1 group session

Acceptability of the ROSE intervention

Timeframe: Week 2 group session

Acceptability of the ROSE intervention

Timeframe: Week 3 group session

Acceptability of the ROSE intervention

Timeframe: Week 4 group session

Acceptability of the ROSE intervention

Timeframe: Week 5 group session

Acceptability of the ROSE intervention

Timeframe: Week 6 group session

Acceptability of the ROSE intervention

Timeframe: Post-birth Visit (4-5 weeks after birth)

Change in level of postpartum depression

Timeframe: 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)

Trial details

NCT IDNCT04940585

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Juliana Zeller

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

View on ClinicalTrials.gov More Post Partum Depression trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Acceptability of the ROSE intervention

Timeframe: Week 1 group session

Acceptability of the ROSE intervention

Timeframe: Week 2 group session

Acceptability of the ROSE intervention

Timeframe: Week 3 group session

Acceptability of the ROSE intervention

Timeframe: Week 4 group session

Acceptability of the ROSE intervention

Timeframe: Week 5 group session

Acceptability of the ROSE intervention

Timeframe: Week 6 group session

Acceptability of the ROSE intervention

Timeframe: Post-birth Visit (4-5 weeks after birth)

Change in level of postpartum depression

Timeframe: 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)