search
Back to results

Utilizing Traditional Practices

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drum-Assisted Recovery Therapy for Native Americans (DARTNA)
Usual Care Plus
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • United American Indian Involvement, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DARTNA

Usual care plus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in alcohol and other drug use based on the Timeline Follow Back
recent alcohol and other drug use will be tracked

Secondary Outcome Measures

Change in physical health status utilizing the Physical health questionnaire (PHQ)
This assessment is a brief self-report scale of somatic symptoms.
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 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.

Full Information

First Posted
March 27, 2017
Last Updated
October 2, 2019
Sponsor
University of California, Los Angeles
Collaborators
RAND
search

1. Study Identification

Unique Protocol Identification Number
NCT03164577
Brief Title
Utilizing Traditional Practices
Official Title
Utilizing Traditional Practices to Decrease Substance Use Among Native Americans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
RAND

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DARTNA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care plus
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Drum-Assisted Recovery Therapy for Native Americans (DARTNA)
Intervention Description
An intervention that utilizes AI/AN drumming as its core component of treatment.
Intervention Type
Other
Intervention Name(s)
Usual Care Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in alcohol and other drug use based on the Timeline Follow Back
Description
recent alcohol and other drug use will be tracked
Time Frame
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 Outcome Measure Information:
Title
Change in physical health status utilizing the Physical health questionnaire (PHQ)
Description
This assessment is a brief self-report scale of somatic symptoms.
Time Frame
Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Title
Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded
Description
This 23-item spirituality scale measures comfort and strength derived from one's spiritual beliefs or connection to God or a Higher Power.
Time Frame
Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Title
Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3
Description
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.
Time Frame
Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
30 males and 30 females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
United American Indian Involvement, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utilizing Traditional Practices

We'll reach out to this number within 24 hrs