Culturally Engaged REcovery: MOms Connected Through Native CommunitY
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT06747442
- Status
- Not Yet Recruiting
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Conditions
- Cultural Adaptation
- Maternal Morbidity and Mortality
- Pregnancy
- Substance Use Disorders (SUD)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
Pregnant and postpartum American Indian and Alaska Native people (Native mothers) face a more than two-fold higher risk of maternal mortality compared to non-Hispanic White mothers. Deaths related to substance use (SU) and mental health conditions are a leading cause of preventable maternal mortality, including among Native mothers, making these conditions a strong target for reducing maternal mortality and morbidity. The objective of our study is to 1) adapt evidence-based perinatal care models that integrate pregnancy and postpartum care with SU treatment and care to meet the needs of Native mothers, and 2) assess the implementation and efficacy of that model for participants with substance use disorder who identify as Native receiving prenatal care at Sacred Circle Healthcare in Salt Lake City, Utah.
Key Dates
- Start date
- Apr 30, 2025
- Status verified
- Dec 2024
- Primary completion
- Sep 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 270 participants (estimated)
Arms
- Arm: CEREMONYAny Native individuals seeking treatment in the integrated perinatal SUD clinical program specifically created for Native mothers may opt to enroll in prospective data collection during their time in the program
- Arm: Contemporary comparison cohortUtah Population Database will be queried for individuals who could have met criteria for prospective data collection but did not participate in the SUD clinical program. The outcomes of these individuals (administrative data only) will be compared to individuals taking part in the SUD program for Native pregnant people who agree to have their data collected.
Primary Outcome Measure
Postpartum engagement in care [ Time Frame: From enrollment until 12 weeks after delivery ]
Central Contacts
- Valerie Joseph Regulatory Coordinator801-587-2249
- Priscilla Blosser801-213-6117
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sacred Circle Healthcare | Salt Lake City | Utah | 84111 | - |
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