Gii'Igoshimong: Sitting With Your First Family

NCT07075081 | Recruiting Phase 2 DMC

• 2 other identifiers: IRB00030209R01DA057904
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use; Mental Health Issue

Outcome Measures

Primary Outcomes (3)

• Days of substance use assessed by Timeline Follow Back (TLFB)

  Days of substance use

  baseline, 1 month, 6 month

• Flourishing Scale

  Score range: 8-40; lower score means higher Positive mental health

  baseline, 1 month, 6 month

• Late Positive Potential (LPP) quantified as the average EEG response in microvolts to adjectives in the Self-referential Processing Task

  Larger magnitude LPP (i.e., higher microvolts) indicates larger attention engagement

  baseline, 1 month, 6 month

Secondary Outcomes (4)

• Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

  baseline, 1 month, 6 month

• Center for Epidemiologic Studies Depression Scale (CESDR-10)

  baseline, 1 month, 6 month

• General Anxiety Disorder-7 (GAD-7)

  baseline, 1 month, 6 month

• Self-rated (physical, mental, spiritual) health

  baseline, 1 month, 6 month

Other Outcomes (4)

• Oslo Social Support Scale (OSSS)

  baseline, 1 month, 6 month

• Cultural efficacy

  baseline, 1 month, 6 month

• Traditional Spiritual Activities score

  baseline, 1 month, 6 month

Study Arms (2)

Ceremony

EXPERIMENTAL

Completes baseline, ceremony, and post assessments (in that order).

Other: Ceremony

Waitlist control

NO INTERVENTION

Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement.

Interventions

Ceremony OTHER

Lifecourse ceremony led by Elders that used to be offered to everyone prior to colonization

Ceremony

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 18 years of age or older,
• Self-identify as Ojibwe/Anishinaabe/Chippewa,
• Self-report using any kind of substances in the past 30 days,
• Have no history of head injury with loss of consciousness,
• Do not have a seizure disorder,
• Do not currently have Type 2 Diabetes,
• Are not currently pregnant

You may not qualify if:

• Younger than18 years of age
• Does not Self-identify as Ojibwe/Anishinaabe/Chippewa,
• Does not self-report using any kind of substances in the past 30 days,
• Has history of head injury with loss of consciousness,
• Has Type 2 Diabetes,
• Has a seizure disorder,
• Currently pregnant

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Great Lakes Hub

Duluth, Minnesota, 55812, United States

RECRUITING

Related Publications (1)

• Gonzalez MB, Johnson AZ, Martin LA, Naawakwe, Fish J, Sevillano L, Walls ML, Staples LO. Planting the seed: using research as a tool to revitalize puberty ceremonies in Anishinaabe communities. Qual Res J. 2024 Dec 4;24(5):473-490. doi: 10.1108/QRJ-03-2024-0072. Epub 2024 Oct 10.

  PMID: 40191601 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Migis Gonzalez, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miigis B Gonzalez, PhD

CONTACT

2183494603; mgonza75@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, data collectors, and data analysts will be blinded to participant randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)