Culturally Engaged REcovery: MOms Connected Through Native communitY

NCT06747442 | Recruiting

• 2 other identifiers: 00177269U54HD113169
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Postpartum engagement in care

  Completion of a postpartum follow up visit within 8 weeks of delivery

  From enrollment until 12 weeks after delivery

Secondary Outcomes (1)

• Medication for opioid use disorder

  Enrollment through 1 year postpartum

Study Arms (2)

CEREMONY

EXPERIMENTAL

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

Behavioral: Cradleboard Journey

Contemporary comparison cohort

NO INTERVENTION

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.

Interventions

Cradleboard Journey BEHAVIORAL

Cradleboard Journey is an integrated perinatal substance use disorder group clinical program specifically created for Native mothers.

CEREMONY

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Sacred Circle Healthcare

Salt Lake City, Utah, 84111, United States

RECRUITING

Related Publications (1)

• 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. 2026 Jan;47(1):233-242. doi: 10.1177/29767342251336550. Epub 2025 Sep 15.

  PMID: 40955087 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michelle Debbink, MD PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Adam Gordon, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Joseph Regulatory Coordinator

CONTACT

801-587-2249; valerie.joseph@hsc.utah.edu

Priscilla Blosser

CONTACT

801-213-6117; priscilla.blosser@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will complete a type I hybrid effectiveness-implementation study to provide important data on clinical effectiveness by comparison to a historical cohort, with a robust statistical analysis plan to address selection bias. We plan to recruit 150 participants prospectively, with an expected final enrollment of 120, and compare them to a deidentified historical cohort of roughly 120 individuals.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: May 26, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)