Substance Use Disorders
Conditions
Keywords
American Indians, Native Americans, substance abuse, culture
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.
Interventions
BEHAVIORALDARTNA
3-hour protocol provided 2x/week over 12 weeks
BEHAVIORALTreatment-As-Usual
Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug and Alcohol Use as a Measure of Treatment Effectiveness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension | 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. |
| Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory. | 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. |
Countries
United States
Participant flow
Recruitment details
The recruitment period lasted from Sept, 2011-August 2012 and took place at United American Indian Involvement, Inc.
Pre-assignment details
No enrolled participants were excluded from the trial before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Treatment-As-Usual Substance Abuse treatment typically received at United American Indian Involvement (UAII) | 4 |
| Drum-Assisted Recovery Therapy for Native Americans 12-week treatment protocol consisting of drum therapy for Native Americans | 6 |
| Total | 10 |
Baseline characteristics
| Characteristic | Drum-Assisted Recovery Therapy for Native Americans | Treatment-As-Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 50.3 years STANDARD_DEVIATION 3.9 | 35.3 years STANDARD_DEVIATION 9 | 44.3 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 6 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 |
Outcome results
Primary
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.
Time frame: Change from Baseline in Drug and Alcohol use at 6 months
Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.
Secondary
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.
Time frame: Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks
Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.
Secondary
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.
Time frame: Change from Baseline in Mental Health and psychosocial characteristics at 6 months
Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.