NCT06747442 Culturally Engaged REcovery: MOms Connected Through Native communitY
| NCT ID | NCT06747442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Substance Use Disorders (SUD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2026-05-26 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 this 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.
Eligibility Criteria
CEREMONY Inclusion Criteria: * English or Spanish speaking * pregnant (verified by point of care urine pregnancy test) * plan to carry the fetus to delivery * identify as Indigenous, Native, Native American, American Indian or Alaska Native * willing to grant a release of information to allow study staff to contact other health care institutions and treatment centers and collect information from the medical record, e.g., date of delivery, infant admission etc. CEREMONY Exclusion Criteria: * have a documented psychotic episode in the last 30 days * be \>39 weeks of gestation * be unable provide collateral contact information of at least 1 person * be unable to provide reliable phone number * plan to move within 3 months of delivery
Contact & Investigator
Michelle Debbink, MD PhD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06747442 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Substance Use Disorders (SUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06747442 currently recruiting?
Yes, NCT06747442 is actively recruiting participants. Contact the research team at valerie.joseph@hsc.utah.edu for enrollment information.
Where is the NCT06747442 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06747442 clinical trial?
NCT06747442 is sponsored by University of Utah. The principal investigator is Michelle Debbink, MD PhD at University of Utah. The trial plans to enroll 270 participants.