- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356667
Drum-Assisted Therapy for Native Americans
May 6, 2018 updated by: Daniel Dickerson, University of California, Los Angeles
Drum-Assisted Recovery Therapy for Native Americans
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90017
- United American Indian Involvement, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Treatment-As-Usual
Substance Abuse treatment typically received
|
Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.
|
|
EXPERIMENTAL: DARTNA
12-week DARTNA program
|
3-hour protocol provided 2x/week over 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drug and Alcohol Use as a Measure of Treatment Effectiveness
Time Frame: Change from Baseline in Drug and Alcohol use at 6 months
|
Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.
|
Change from Baseline in Drug and Alcohol use at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension
Time Frame: Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks
|
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.
|
Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks
|
|
Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.
Time Frame: Change from Baseline in Mental Health and psychosocial characteristics at 6 months
|
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.
|
Change from Baseline in Mental Health and psychosocial characteristics at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel L Dickerson, D.O., M.P.H., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
April 26, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (ESTIMATE)
May 19, 2011
Study Record Updates
Last Update Posted (ACTUAL)
June 28, 2018
Last Update Submitted That Met QC Criteria
May 6, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DARTNA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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