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Drum-Assisted Therapy for Native Americans

Primary Purpose

Substance Use Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DARTNA
Treatment-As-Usual
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 Disorders focused on measuring American Indians, Native Americans, substance abuse, culture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR; American Psychiatric Association, 2000) criteria of current alcohol or drug abuse or dependence
  • self-identifying as at least ¼ American Indian/Alaska Native heritage
  • seeking treatment for alcohol or drug abuse
  • being at least 18 years old. Clients will be assessed for suitability for outpatient treatment.

Exclusion Criteria:

  • have a psychiatric conditions that is not suitable for outpatient treatment (e.g., if they require inpatient rehabilitation treatment, have significant psychiatric disorders, require medical detoxification, or have significant medical problems)
  • have a current suicidal ideation/plan as assessed by the ASI or BSI
  • are mandated by the court to obtain treatment for substance abuse where such mandate requires the results of urine toxicology tests to be reported to the court
  • expectation that the participant will fail to complete the study protocol due to probable incarceration or relocation from the clinic area.

Sites / Locations

  • United American Indian Involvement, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment-As-Usual

DARTNA

Arm Description

Substance Abuse treatment typically received

12-week DARTNA program

Outcomes

Primary Outcome Measures

Drug and Alcohol Use as a Measure of Treatment Effectiveness
Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.

Secondary Outcome Measures

Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension
The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.
Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.
The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.

Full Information

First Posted
April 26, 2011
Last Updated
May 6, 2018
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01356667
Brief Title
Drum-Assisted Therapy for Native Americans
Official Title
Drum-Assisted Recovery Therapy for Native Americans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Study period is over and recruitment was stopped due to time constraints.
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is an R-21 NIH/NCCAM-funded study aimed to complete the development and pilot a new substance abuse treatment protocol utilizing drumming for American Indians/Alaska Natives with substance use disorders. The study includes activities to complete the protocol, followed by a randomized-controlled clinical trial.
Detailed Description
During year 1, this study consists of a series of focus groups conducted among American Indians/Alaska Natives with substance use disorders, providers serving AI/ANs with substance use disorders, and a Community Advisory Board. These focus groups are conducted in order to obtain feedback with regard to the initial DARTNA treatment protocol. These focus groups are then followed by a pretest of DARTNA among 10 AI/ANs with substance use disorders followed by a series of focus groups to finalize the development of DARTNA. During year 2, a randomized controlled will be conducted among 30 AI/ANs receiving the DARTNA treatment protocol vs. 30 AI/ANs receiving treatment-as-usual at United American Indian Involvement, Inc. in Los Angeles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
American Indians, Native Americans, substance abuse, culture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment-As-Usual
Arm Type
Active Comparator
Arm Description
Substance Abuse treatment typically received
Arm Title
DARTNA
Arm Type
Experimental
Arm Description
12-week DARTNA program
Intervention Type
Behavioral
Intervention Name(s)
DARTNA
Intervention Description
3-hour protocol provided 2x/week over 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Treatment-As-Usual
Intervention Description
Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.
Primary Outcome Measure Information:
Title
Drug and Alcohol Use as a Measure of Treatment Effectiveness
Description
Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.
Time Frame
Change from Baseline in Drug and Alcohol use at 6 months
Secondary Outcome Measure Information:
Title
Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension
Description
The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.
Time Frame
Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks
Title
Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.
Description
The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.
Time Frame
Change from Baseline in Mental Health and psychosocial characteristics at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR; American Psychiatric Association, 2000) criteria of current alcohol or drug abuse or dependence self-identifying as at least ¼ American Indian/Alaska Native heritage seeking treatment for alcohol or drug abuse being at least 18 years old. Clients will be assessed for suitability for outpatient treatment. Exclusion Criteria: have a psychiatric conditions that is not suitable for outpatient treatment (e.g., if they require inpatient rehabilitation treatment, have significant psychiatric disorders, require medical detoxification, or have significant medical problems) have a current suicidal ideation/plan as assessed by the ASI or BSI are mandated by the court to obtain treatment for substance abuse where such mandate requires the results of urine toxicology tests to be reported to the court expectation that the participant will fail to complete the study protocol due to probable incarceration or relocation from the clinic area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel L Dickerson, D.O., M.P.H.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
32720004
Citation
Dickerson DL, D'Amico EJ, Klein DJ, Johnson CL, Hale B, Ye F. Mental Health, Physical Health, and Cultural Characteristics Among American Indians/Alaska Natives Seeking Substance Use Treatment in an Urban Setting: A Descriptive Study. Community Ment Health J. 2021 Jul;57(5):937-947. doi: 10.1007/s10597-020-00688-3. Epub 2020 Jul 27.
Results Reference
derived

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Drum-Assisted Therapy for Native Americans

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