Clinical trial NCT03164577: Utilizing Traditional Practices
Official title: Utilizing Traditional Practices to Decrease Substance Use Among Native Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: RAND
First posted: 2017-05-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in alcohol and other drug use based on the Timeline Follow Back
timeFrame: Change from baseline alcohol and other drug use at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Secondary outcomes:
measure: Change in physical health status utilizing the Physical health questionnaire (PHQ)
timeFrame: Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
measure: Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded
timeFrame: Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
measure: Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3
timeFrame: Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: United American Indian Involvement, Inc.
state: California
Study officials:
References: