Substance Use DisordersNCT01356667
Drum-Assisted Therapy for Native Americans
A study testing DARTNA and Treatment-As-Usual in people with Substance Use Disorders, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- DARTNA and Treatment-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
United American Indian Involvement, Inc.
Los Angeles, California, 90017
About this study
Official title: 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.
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.
- Conditions
- Substance Use Disorders
- Being tested
- DARTNA, Treatment-As-Usual
- Keywords
- American Indians, Native Americans, substance abuse, culture
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DARTNABehavioural
3-hour protocol provided 2x/week over 12 weeks
Treatment-As-UsualBehavioural
Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-As-Usual | Active comparator | Substance Abuse treatment typically received Receives: Behavioral: Treatment-As-Usual |
| DARTNA | Experimental | 12-week DARTNA program Receives: Behavioral: DARTNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in Drug and Alcohol use at 6 months
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: Change from Baseline in Mental Health and psychosocial characteristics at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Study period is over and recruitment was stopped due to time constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Dickerson, University of California, Los Angeles
- Investigators
- Daniel L Dickerson, D.O., M.P.H., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356667
- Sponsor's protocol ID
- DARTNA
- Status last verified
- May 2018
- First submitted
- 26 Apr 2011
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drum-Assisted Recovery Therapy for Native Americans
- ClinicalTrials.gov ID
- NCT01356667
- Acronym / sponsor ID
- DARTNA
- Conditions
- Substance Use Disorders
- Keywords
- American Indians, Native Americans, substance abuse, culture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study period is over and recruitment was stopped due to time constraints.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-As-Usual | Active comparator | Behavioral: Treatment-As-UsualSubstance Abuse treatment typically received |
| DARTNA | Experimental | Behavioral: DARTNA12-week DARTNA program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DARTNA3-hour protocol provided 2x/week over 12 weeks | Behavioural | DARTNA |
| Treatment-As-UsualParticipants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions. | Behavioural | Treatment-As-Usual |
Primary outcome
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.
2 secondary outcomes
Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32720004Dickerson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel L Dickerson, D.O., M.P.H. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DARTNA and Treatment-As-Usual in people with Substance Use Disorders, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug and Alcohol Use as a Measure of Treatment Effectiveness (time frame: Change from Baseline in Drug and Alcohol use at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01356667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.