Recruiting

Perinatal Care Model

Sponsor:

University of Utah

Code:

NCT06747442

Conditions

Substance Use Disorders (SUD)

Pregnancy

Maternal Morbidity and Mortality

Cultural Adaptation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cradleboard Journey

Study Details

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

Study ID

NCT06747442

Start date

May 26, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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 intervention: 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.

Interventions

Cradleboard Journey

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

Primary outcome measure

  • Postpartum engagement in care [ Time Frame: From enrollment until 12 weeks after delivery ]

Central Contacts and Locations

Central contacts

Valerie Joseph Regulatory Coordinator

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

Priscilla Blosser

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

Locations

Sacred Circle Healthcare

Recruiting

Salt Lake City, Utah, United States, 84111

More Information

Sponsor

University of Utah

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-07-07.