Utilizing Traditional Practices
Utilizing Traditional Practices to Decrease Substance Use Among Native Americans
This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico, co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization providing consultative services for American Indians/Alaska Natives (AI/ANs).
A feasibility randomized clinical trial will be conducted within an urban setting and will compare urban AI/AN males and females with AOD disorders who receive DARTNA (n=30) to AI/AN males and females with AOD disorders who receive usual care plus (n=30). Compare outcomes at end of treatment and 3-months post-treatment to gather data that can be used to judge the feasibility of a larger trial, and to plan that trial. Obtain information on (a) clinically significant changes in AOD use, (b) clinically significant changes in mental health, physical health, spirituality, cognition, adoption of 12-step principles and practices, and cultural identification, and (c) estimate covariate correlations, reliability of measures and likely effect sizes.
研究概览
地位
条件
详细说明
Alcohol and other drug (AOD) abuse among American Indians and Alaska Natives (AI/ANs) is a significant health issue in the United States as rates of AOD use among AI/ANs have continually been high since national data were collected among AI/ANs beginning in the 1980's. In 2013, AI/ANs had the highest rate of AOD dependence and abuse compared with other racial groups.
However, very few AOD abuse treatments utilizing traditional based healing, such as drumming, have undergone rigorous scientific research. Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is a new AOD use intervention integrating AI/AN drumming, 12-step philosophy, and concepts focused on the Medicine Wheel. In a recently completed National Center for Complementary and Alternative Medicine (NCCAM)-funded study (R21AT005360), the PI completed key components of DARTNA development (stage 1a) including demonstrating feasibility and acceptability, establishing procedures for therapist adherence procedures, developing a treatment manual, and conducting a pretest among ten AI/AN men (n=5) and women (n=5) with promising preliminary findings.
This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico, co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization providing consultative services for American Indians/Alaska Natives (AI/ANs).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Los Angeles、California、美国、90017
- United American Indian Involvement, Inc.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1) self-identify as AI/AN male or female, (2) be seeking treatment for their drug or alcohol dependence; (3) be 18-59 years of age or older; (4) meet Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) criteria for AOD use disorders;
Exclusion Criteria:
1. have a mental health or medical history that, in the judgment of the study physician or PI, show no clinically significant contraindications for study participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：DARTNA
DARTNA is a culturally-adaptable therapeutic drum behavior therapy that incorporates drumming, talking circles, and uses the 12 Steps of Alcoholics Anonymous (AA)/Narcotics Anonymous (NA) program within the conceptual framework of the Northern Plains Medicine Wheel.
The Northern Plains Medicine Wheel is widely utilized as a conceptual framework and integrative approach to health and wellness for AI/ANs.
This intervention consists of 12 sessions provided 2 times weekly over 6 weeks.
|
An intervention that utilizes AI/AN drumming as its core component of treatment.
|
|
安慰剂比较：Usual care plus
Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants.
They will engage in health and wellness education session once weekly for 6 weeks.
They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.
|
Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants.
They will engage in health and wellness education session once weekly for 6 weeks.
They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in alcohol and other drug use based on the Timeline Follow Back
大体时间：Change from baseline alcohol and other drug use at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
recent alcohol and other drug use will be tracked
|
Change from baseline alcohol and other drug use at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in physical health status utilizing the Physical health questionnaire (PHQ)
大体时间：Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
This assessment is a brief self-report scale of somatic symptoms.
|
Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
|
Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded
大体时间：Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
This 23-item spirituality scale measures comfort and strength derived from one's spiritual beliefs or connection to God or a Higher Power.
|
Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
|
Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3
大体时间：Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
This 37-item cognitive function scale measures areas associated with cognitive function, including perceived cognitive impairments, comments from others (i.e., observations by others regarding cognition), perceived cognitive abilities, and impact on quality of life.
|
Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.