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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01356667
Other study ID # DARTNA
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date August 2012

Study information

Verified date May 2018
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 ΒΌ 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
DARTNA
3-hour protocol provided 2x/week over 12 weeks
Treatment-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.

Locations

Country Name City State
United States United American Indian Involvement, Inc. Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Change from Baseline in Drug and Alcohol use at 6 months
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. 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. Change from Baseline in Mental Health and psychosocial characteristics at 6 months
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