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Study period is over and recruitment was stopped due to time constraints.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-As-Usual | Active Comparator | Substance Abuse treatment typically received |
|
| DARTNA | Experimental | 12-week DARTNA program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DARTNA | Behavioral | 3-hour protocol provided 2x/week over 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline in Drug and Alcohol use at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel L Dickerson, D.O., M.P.H. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United American Indian Involvement, Inc. | Los Angeles | California | 90017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32720004 | Derived | 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. |
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No enrolled participants were excluded from the trial before assignment to groups.
The recruitment period lasted from Sept, 2011-August 2012 and took place at United American Indian Involvement, Inc.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-As-Usual | Substance Abuse treatment typically received at United American Indian Involvement (UAII) |
| FG001 | Drum-Assisted Recovery Therapy for Native Americans | 12-week treatment protocol consisting of drum therapy for Native Americans |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-As-Usual | Substance Abuse treatment typically received at United American Indian Involvement (UAII) |
| BG001 | Drum-Assisted Recovery Therapy for Native Americans | 12-week treatment protocol consisting of drum therapy for Native Americans |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Please be advised that this clincial trial was terminated prior to finalization of any research procedures. | Posted | Change from Baseline in Drug and Alcohol use at 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment-As-Usual | Substance Abuse treatment typically received at United American Indian Involvement (UAII) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Dickerson | UCLA, Integrated Substance Abuse Programs | 562-277-0310 | daniel.dickerson@ucla.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Treatment-As-Usual |
| Behavioral |
Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions. |
|
| 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. | Change from Baseline in Mental Health and psychosocial characteristics at 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Please be advised that this clincial trial was terminated prior to finalization of any research procedures. | Posted | Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks |
|
|
| 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. | Please be advised that this clincial trial was terminated prior to finalization of any research procedures. | Posted | Change from Baseline in Mental Health and psychosocial characteristics at 6 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Drum-Assisted Recovery Therapy for Native Americans | 12-week treatment protocol consisting of drum therapy for Native Americans | 0 | 6 | 0 | 6 |
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