Culturally Engaged REcovery: MOms Connected Through Native communitY

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
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 design

Design model

Single group

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: CEREMONYExperimental treatment 1 intervention
Group B: Contemporary comparison cohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

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University of Utah

Lead sponsor

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

Collaborator