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
- Mental Health Issue
- Substance Use
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Ceremony — OTHERLifecourse 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: CeremonyCompletes baseline, ceremony, and post assessments (in that order).
- No Intervention: Waitlist controlCompletes 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
- Miigis B Gonzalez, PhD2183494603
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Great Lakes Hub | Duluth | Minnesota | 55812 | Miigis Gonzalez, PhD (PRINCIPAL_INVESTIGATOR) |
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