The Protective Role of Ceremony Against Substance Use for American Indian Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Days of substance use assessed by Timeline Follow Back (TLFB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators, data collectors, and data analysts will be blinded to participant randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •18 years of age or younger
- •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
研究组 & 干预措施
Ceremony
Completes baseline, ceremony, and post assessments (in that order).
干预措施: Ceremony (Other)
Waitlist control
Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement.
结局指标
主要结局
Days of substance use assessed by Timeline Follow Back (TLFB)
时间窗: baseline, 1 month, 6 month
Days of substance use
Flourishing Scale
时间窗: baseline, 1 month, 6 month
Score range: 8-40; lower score means higher Positive mental health
Late Positive Potential (LPP) quantified as the average EEG response in microvolts to adjectives in the Self-referential Processing Task
时间窗: baseline, 1 month, 6 month
Larger magnitude LPP (i.e., higher microvolts) indicates larger attention engagement
次要结局
- 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)