Gii'Igoshimong: Sitting With Your First Family
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Ceremony
Other interventionLifecourse ceremony led by Elders that used to be offered to everyone prior to colonization
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: CeremonyExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Days of substance use assessed by Timeline Follow Back (TLFB)
Days of substance use
Time frame
baseline, 1 month, 6 month2
Flourishing Scale
Score range: 8-40; lower score means higher Positive mental health
Time frame
baseline, 1 month, 6 month3
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
Time frame
baseline, 1 month, 6 monthSecondary outcomes
1
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Score range: 0-27; lower score is indicative of lower risk
Time frame
baseline, 1 month, 6 month2
Center for Epidemiologic Studies Depression Scale (CESDR-10)
Scale range: 0-40; lower score = lower depression
Time frame
baseline, 1 month, 6 month3
General Anxiety Disorder-7 (GAD-7)
Scale range: 7-28; lower scores indicates lower anxiety
Time frame
baseline, 1 month, 6 month4
Self-rated (physical, mental, spiritual) health
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
Time frame
baseline, 1 month, 6 monthOther outcomes
1
Oslo Social Support Scale (OSSS)
Scale range: 3-14; higher score is better
Time frame
baseline, 1 month, 6 month2
Cultural efficacy
Adapted from Native Wellness Assessment; Score range: 20-28; lower score is better
Time frame
baseline, 1 month, 6 month3
Traditional Spiritual Activities score
Score range: 12-24; lower score is better
Time frame
baseline, 1 month, 6 month4
Spiritual Values score
Score range: 1-4; lower score is better
Time frame
baseline, 1-month post, 6-month postSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov