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Gii'Igoshimong: Sitting With Your First Family

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study completion pushed from May 2029 to May 31, 2029
    • Primary completion date: Dec 2028 to Dec 1, 2028
    • Eligibility criteria shortened, about 1 word
    v5
  2. Eligibility criteria expanded, about 10 wordsv4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Aug 2025 to Sep 9, 2025
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07075081
Lead Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Substance Use, Mental Health Issue
Related terms Substance-Related Disorders
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov