Utilizing Traditional Practices

Substance Use Clinical Trial

Official title:

Utilizing Traditional Practices to Decrease Substance Use Among Native Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164577
• Other study ID #: 1R34AA024818-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 31, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use

Intervention

Behavioral:
• Drum-Assisted Recovery Therapy for Native Americans (DARTNA)
An intervention that utilizes AI/AN drumming as its core component of treatment.

Other:
• 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.

Locations

Country	Name	City	State
United States	United American Indian Involvement, Inc.	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alcohol and other drug use based on the Timeline Follow Back	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)
Secondary	Change in physical health status utilizing the Physical health questionnaire (PHQ)	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)
Secondary	Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded	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)
Secondary	Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3	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)