Culturally Engaged REcovery: MOms Connected Through Native CommunitY

NCT ID: NCT06747442

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-12-31

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 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.

Detailed Description

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 reflect a leading cause of preventable maternal mortality, including among Native mothers, making these conditions a strong target for reducing maternal mortality and morbidity. The Utah Maternal Mortality Review Committee (MMRC) has identified access to substance use disorder (SUD) treatment including medication for opioid use disorder (MOUD), mental health care, improved social support, decreased stigma against SUD, and care coordination, particularly in the postpartum period (when the majority of deaths occur) as actionable intervention points. The objective of our study, Culturally-Engaged REcovery - MOms connected through Native CommunitY (CEREMONY), is to adapt evidence-based perinatal care models that integrate pregnancy and postpartum care with SU/SUD treatment and care to meet the needs of Native mothers. With our partners at Sacred Circle Clinic, a federal Tribal Contract clinic operated by the Confederated Tribes of the Goshute Reservation, we are uniquely poised to respond to the expressed needs of Native mothers and stakeholders, who identified a lack of culturally-integrated SUD care as a significant gap in perinatal care for Native mothers. We will do this by building upon the strong, evidence-based foundation of our University of Utah integrated perinatal SUD clinic called Substance Use and Pregnancy - Recovery, Addiction, and Dependence (SUPeRAD). The SUPeRAD model directly addresses the actionable intervention points identified by the MMRC to prevent SUD-related maternal deaths, but is not specifically adapted to Native mothers' needs. The rationale for this study is that there is a critical knowledge gap in the adaptation and implementation of integrated perinatal SUD care specifically for Native mothers. The CEREMONY study will fill this gap by adapting the SUPeRAD clinic model to the needs of Native mothers using the validated ADAPT-ITT adaptation framework, informed by human centered design and community-based participatory research (Aim 1; not part of the observation trial submission described on this website); and then studying the adapted, culturally-integrated perinatal SUD care intervention at Sacred Circle Healthcare using a Hybrid Type 1 effectiveness-implementation study (Aim 2a&b). The Hybrid Type 1 design will provide important, reliable data on the clinical effectiveness of culturally adapted perinatal SUD care for Native mothers (Aim 2a) while also producing novel data on the implementation process (Aim 2b). Successful completion of these Aims will provide implementation and training protocols that can be used to guide adaptation and implementation of culturally-adapted perinatal SUD care in other settings across the US.

Sacred Circle Healthcare will be implementing the new care model and offering it to all patients who identify as Native and having a substance use disorder. Within that group, the CEREMONY study will invite patients who meet study inclusion criteria to participate in the observational research study.

Participants enrolled prospectively will be compared to a historical cohort, with data pulled from the Utah Population Database, for our primary outcome. The historical cohort will be comprised on deidentified data from individuals over 18 years old with delivery of an infant greater than 20 weeks' gestation between 2020 and the most recent year of available data (approximately 2027-28) who had at least one visit with a Utah health provider before delivery and identify as American Indian/Alaska Native based on vital records or hospital records.

Conditions

Substance Use Disorders (SUD); Pregnancy; Maternal Morbidity and Mortality; Cultural Adaptation

Keywords

Pregnancy; Prenatal care; Substance Use Disorder; Native and Indigenous Health; Culturally adapted care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CEREMONY

Any 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

No interventions assigned to this group

Contemporary comparison cohort

Utah 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.

No interventions assigned to this group

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Michelle Debbink

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Debbink, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Adam Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Sacred Circle Healthcare

Salt Lake City, Utah, United States

Countries

United States

Central Contacts

Valerie Joseph Regulatory Coordinator

Role: CONTACT

Phone: 801-587-2249

Email: valerie.joseph@hsc.utah.edu

Priscilla Blosser

Role: CONTACT

Phone: 801-213-6117

Email: priscilla.blosser@hsc.utah.edu

References

Debbink MP, Tanana H, Murray JL, Blosser P, Horse L, Monroy C, Spiess S, Charles JE, Turok DK, Smid MC, Allshouse AA, Smith JD, Cohen SR, Johnson EP, Metz TD, Gordon AJ. Culturally Engaged REcovery - MOms connected through Native CommunitY (CEREMONY): An Implementation Study to Evaluate the Adaptation and Implementation of an Integrated Perinatal SUD Clinical Model for Pregnant and Postpartum Native People. Subst Use Addctn J. 2025 Sep 15:29767342251336550. doi: 10.1177/29767342251336550. Online ahead of print.

Reference Type: DERIVED

PMID: 40955087 (View on PubMed)

Other Identifiers

U54HD113169

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00177269

Identifier Type: -

Identifier Source: org_study_id