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NCT Number: NCT07075081

Gii'Igoshimong: Sitting With Your First Family

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Great Lakes Hub

Duluth, Minnesota, 55812, United States

Location status: Recruiting

Location contact

Miigis Gonzalez, PhD

CONTACT

[email protected]

218-349-4603

Miigis Gonzalez, PhD

PRINCIPAL_INVESTIGATOR

About this study

This project seeks to engage American Indian (AI) adults with community and spiritual worldviews via ceremony (Gii'igoshimong). In doing so, the investigators will attempt to buffer the effects of historical trauma, personal trauma, and lifelong risk factors for substance use, thereby improving substance use behaviors, related outcomes, and overall health.

The Community-Based Participatory Research will enroll AI adults (Aim 2 & 3) to implement a randomized controlled trial (N = 300 target adults) with a wait-list design respectful of cultural norms of inclusion. The investigators will evaluate the relationship between ceremony and adult substance use and identify multilevel factors (i.e., psychosocial, neurocognitive) through which traditional practices convey protection against substance use. The investigators will assess and develop a menu of implementation strategies (Sub-aim 2) to support community priority of long-term sustainment of the ceremonial practice.

TRIAL (Aim 2):

An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial with N = 300 participants. Once enrolled and consented into the trial, participants will complete baseline assessments. Once baseline assessments are complete, participants will be randomized into either intervention (ceremony) or control (wait-list). Intervention is an up to four-day ceremony, that was traditionally offered to every Anishinaabe person when the Anishinaabe person reached puberty. Today, this ceremony is being revived, and yet, accessibility to this ceremonial opportunity remains low. Ceremony will be described in more detail below. Both intervention and control arms will complete 1 month post and 6-month post assessments. Control arm participants will be offered the ceremony after completion of the 6-month assessments.

POST-CEREMONY FOCUS GROUP DISCUSSIONS (FGD) (Sub-aim 2) The investigators will conduct focus group discussions (FGDs) with ceremony treatment arm participants at six months post-baseline (6 total FGDs) to get participant feedback on the ceremony, thoughts on the effects of participation, and suggestions for strengthening implementation.

KEY INFORMANT INTERVIEWS (KII) (Sub-aim 2) The investigators will conduct key informant interviews (KIIs) with ceremony leaders at mid-trial to get feedback on ceremony implementation and suggestions for improving implementation moving forward.

IMPLEMENTATION MAPPING FGD (Sub-aim 2) The investigators will conduct two sequential FGDs with ceremony leaders and other community leaders. In the first implementation mapping FGD, the investigators will present the results of the KIIs/FGDs that were done during the trial, outlining what the investigators think are the key issues/barriers to implementation of the ceremony in the community moving forward. The investigators will then facilitate a group discussion where the investigators try to reach consensus on those issues. After FGD 1, the investigators will (independently) try to come up with some strategies that the tribe could use to support implementation in the long-term. In FGD 2, the investigators will present these back to the same group and get feedback/try to seek consensus

ELECTROENCEPHALOGRAPHY (EEG) (Aim 3) The investigators will examine the neurocognitive effects of Gii'igoshimong ceremony and associated stimuli relevant to reducing substance use. This study will establish the measurement validity of electroencephalography/event related potential (EEG/ERP) indicators of self-referential processing and an indicator of cultural identification, a critical step in the science of delineating the potential of cultural factors as disease modifying processes. EEG assessments will be a required activity of the Trial. These assessments will be completed at the same time as Trial survey assessments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ceremony

Other

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

Primary outcomes

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

    Time frame: baseline, 1 month, 6 month

    Days of substance use

  2. Flourishing Scale

    Time frame: baseline, 1 month, 6 month

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

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

    Time frame: baseline, 1 month, 6 month

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

Secondary outcomes

  1. Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    Time frame: baseline, 1 month, 6 month

    Score range: 0-27; lower score is indicative of lower risk

  2. Center for Epidemiologic Studies Depression Scale (CESDR-10)

    Time frame: baseline, 1 month, 6 month

    Scale range: 0-40; lower score = lower depression

  3. General Anxiety Disorder-7 (GAD-7)

    Time frame: baseline, 1 month, 6 month

    Scale range: 7-28; lower scores indicates lower anxiety

  4. Self-rated (physical, mental, spiritual) health

    Time frame: baseline, 1 month, 6 month

    Adapted from the Composite International Diagnostic Interview; Score ranges 1-5 for physical health; Score ranges 1-5 for mental health; Score ranges 1-5 for spiritual health; lower score is better

Other outcomes

  1. Oslo Social Support Scale (OSSS)

    Time frame: baseline, 1 month, 6 month

    Scale range: 3-14; higher score is better

  2. Cultural efficacy

    Time frame: baseline, 1 month, 6 month

    Adapted from Native Wellness Assessment; Score range: 20-28; lower score is better

  3. Traditional Spiritual Activities score

    Time frame: baseline, 1 month, 6 month

    Score range: 12-24; lower score is better

  4. Spiritual Values score

    Time frame: baseline, 1-month post, 6-month post

    Score range: 1-4; lower score is better

Study contacts

Contact information is provided by the study sponsor or research team.

Miigis B Gonzalez, PhD

CONTACT

[email protected]

2183494603

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

The Protective Role of Ceremony Against Substance Use for American Indian Adults

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 20, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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