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TerminatedNCT01356667Updated Jun 28, 2018Results posted

Drum-Assisted Therapy for Native Americans

An interventional study of DARTNA and Treatment-As-Usual in Substance Use Disorders, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Why this study was terminated
Study period is over and recruitment was stopped due to time constraints.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Substance Use Disorders

Keywords

  • American Indians
  • Native Americans
  • substance abuse
  • culture
03

In context

Substance-Related Disorders

2,126 studies on the registry are indexed under Substance-Related Disorders; 395 are open to participants now.

This study's enrollment of 10 is below the median of 109 across 1,728 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Treatment-As-Usual

    Substance Abuse treatment typically received

    Behavioral: Treatment-As-Usual

  • Experimental
    DARTNA

    12-week DARTNA program

    Behavioral: DARTNA

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Dec 12, 2014

Participant flow

The recruitment period lasted from Sept, 2011-August 2012 and took place at United American Indian Involvement, Inc.

Participant flow — Overall Study
MilestoneTreatment-As-UsualDrum-Assisted Recovery Therapy for Native Americans
Started46
Completed00
Not completed46

Outcome measures

PrimaryDrug 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

No measurements were reported for this outcome.

SecondaryKnowledge 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

No measurements were reported for this outcome.

SecondaryMental 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

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment-As-Usual—0/4 (0%)0/4 (0%)
Drum-Assisted Recovery Therapy for Native Americans—0/6 (0%)0/6 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment-As-UsualDrum-Assisted Recovery Therapy for Native AmericansTotal
<=18 years000
Between 18 and 65 years4610
>=65 years000
Age, Continuous
Age, Continuous(years)Treatment-As-UsualDrum-Assisted Recovery Therapy for Native AmericansTotal
Mean35.3 ± 9.050.3 ± 3.944.3 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Treatment-As-UsualDrum-Assisted Recovery Therapy for Native AmericansTotal
Female336
Male134
Region of Enrollment
Region of Enrollment(participants)Treatment-As-UsualDrum-Assisted Recovery Therapy for Native AmericansTotal
United States4610
08

Study locations

1 site
  • United American Indian Involvement, Inc.
    Los Angeles, California 90017, United States
09

References and documents

Publications

  • 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. PubMed 32720004 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01356667
Lead sponsor
University of California, Los Angeles
Responsible party
Daniel Dickerson (Assistant Research Psychiatrist, University of California, Los Angeles) — Principal investigator
First posted
May 19, 2011
Start date
Sep 2010
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Dec 12, 2014
Last update
Jun 28, 2018

Study contacts

Daniel L Dickerson, D.O., M.P.H.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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