Culturally Engaged REcovery: MOms Connected Through Native communitY

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity of Utah

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study compares the outcomes of two groups: 1) Native individuals who have decided to participate in a new clinical program for pregnant Native mothers with SUD (program cohort) who then also agree to have their data to collected prospectively; and 2) pregnant Native mothers with SUD identified through administrative data who did not participate in the clinical program. The study population as a whole consists of Native and Indigenous pregnant individuals with SUD in the state of Utah.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: CEREMONY1 intervention

Group B: Contemporary comparison cohort0 interventions

Trial outcomes

Primary outcomes

Postpartum engagement in care

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

Time frame

From enrollment until 12 weeks after delivery

Secondary outcomes

Medication for opioid use disorder

Any prescription of suboxone or methadone for individuals with OUD, and the length of time the prescription is kept current

Time frame

Enrollment through 1 year postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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