Gii'Igoshimong: Sitting With Your First Family

Part of paid clinical trials in Duluth, Minnesota.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT07075081
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ceremony — OTHER
    Lifecourse ceremony led by Elders that used to be offered to everyone prior to colonization

Study Details

The goal of this randomized wait-list control study is to understand the relationship between ceremony and substance use (SU), SU risk (e.g., SU severity, depressive symptoms) and protective factors (e.g., spirituality, community support). The main questions it aims to answer are: * Will adults enrolled in Gii'igoshimong show improved SU outcomes compared to those in control groups? * Will self-relevant processing networks activated during stimulus engagement increase from pre- to post- engagement in ceremony and at 6-month follow-up? Researchers will compare adults that complete Gii'igoshimong with those that do not complete Gii'igoshimong to see if health outcomes are different. After completing baseline assessments, participants will be randomized to complete Gii'igoshimong now (intervention) or after the participants have completed the 1 month and 6-month post assessments (waitlist control). All participants (intervention and waitlist control) within a cohort will complete 1 month and 6 month post assessments at the same time.

Key Dates

Start date
Sep 9, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2028
Completion
May 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ceremony
    Completes baseline, ceremony, and post assessments (in that order).
  • No Intervention: Waitlist control
    Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement.

Primary Outcome Measure

Days of substance use assessed by Timeline Follow Back (TLFB) [ Time Frame: baseline, 1 month, 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Great Lakes HubDuluthMinnesota55812
Miigis Gonzalez, PhD
218-349-4603
Miigis Gonzalez, PhD (PRINCIPAL_INVESTIGATOR)

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