Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03164577
Other study ID # 1R34AA024818-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date August 31, 2019

Study information

Verified date October 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico, co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization providing consultative services for American Indians/Alaska Natives (AI/ANs).

A feasibility randomized clinical trial will be conducted within an urban setting and will compare urban AI/AN males and females with AOD disorders who receive DARTNA (n=30) to AI/AN males and females with AOD disorders who receive usual care plus (n=30). Compare outcomes at end of treatment and 3-months post-treatment to gather data that can be used to judge the feasibility of a larger trial, and to plan that trial. Obtain information on (a) clinically significant changes in AOD use, (b) clinically significant changes in mental health, physical health, spirituality, cognition, adoption of 12-step principles and practices, and cultural identification, and (c) estimate covariate correlations, reliability of measures and likely effect sizes.


Description:

Alcohol and other drug (AOD) abuse among American Indians and Alaska Natives (AI/ANs) is a significant health issue in the United States as rates of AOD use among AI/ANs have continually been high since national data were collected among AI/ANs beginning in the 1980's. In 2013, AI/ANs had the highest rate of AOD dependence and abuse compared with other racial groups.

However, very few AOD abuse treatments utilizing traditional based healing, such as drumming, have undergone rigorous scientific research. Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is a new AOD use intervention integrating AI/AN drumming, 12-step philosophy, and concepts focused on the Medicine Wheel. In a recently completed National Center for Complementary and Alternative Medicine (NCCAM)-funded study (R21AT005360), the PI completed key components of DARTNA development (stage 1a) including demonstrating feasibility and acceptability, establishing procedures for therapist adherence procedures, developing a treatment manual, and conducting a pretest among ten AI/AN men (n=5) and women (n=5) with promising preliminary findings.

This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico, co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization providing consultative services for American Indians/Alaska Natives (AI/ANs).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 31, 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1) self-identify as AI/AN male or female, (2) be seeking treatment for their drug or alcohol dependence; (3) be 18-59 years of age or older; (4) meet Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) criteria for AOD use disorders;

Exclusion Criteria:

1. have a mental health or medical history that, in the judgment of the study physician or PI, show no clinically significant contraindications for study participation.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Drum-Assisted Recovery Therapy for Native Americans (DARTNA)
An intervention that utilizes AI/AN drumming as its core component of treatment.
Other:
Usual Care Plus
Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants. They will engage in health and wellness education session once weekly for 6 weeks. They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles RAND

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in alcohol and other drug use based on the Timeline Follow Back recent alcohol and other drug use will be tracked Change from baseline alcohol and other drug use at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Secondary Change in physical health status utilizing the Physical health questionnaire (PHQ) This assessment is a brief self-report scale of somatic symptoms. Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Secondary Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded This 23-item spirituality scale measures comfort and strength derived from one's spiritual beliefs or connection to God or a Higher Power. Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
Secondary Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3 This 37-item cognitive function scale measures areas associated with cognitive function, including perceived cognitive impairments, comments from others (i.e., observations by others regarding cognition), perceived cognitive abilities, and impact on quality of life. Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05806840 - Rapid Adaptation to Prevent Drug Use N/A
Recruiting NCT06003725 - Cultural Adaptation of Drug Treatment for DJJ Youth N/A
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Recruiting NCT05768815 - Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright N/A
Completed NCT05606601 - An Online Intervention Addressing Mental Health and Substance Use in University Students N/A
Completed NCT03489434 - Technology-Based Prevention for Adolescents in Primary Care N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT02990026 - Specialty Mental Health Probation in North Carolina N/A
Not yet recruiting NCT06116266 - Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care) N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Active, not recruiting NCT03129334 - Preventing Prescription Drug Abuse in Middle School Students N/A
Completed NCT04183400 - Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness N/A
Completed NCT02112201 - The ProGirls Study N/A
Completed NCT01752998 - Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings N/A
Terminated NCT01661517 - Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting Phase 0
Completed NCT01351454 - Behavioral Depression Treatment for African American HIV-infected Substance Users N/A
Completed NCT01511380 - Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth Phase 2
Completed NCT01154309 - Group CBT for Depression and AOD Disorders Phase 1
Completed NCT00996541 - Support To Reunite Involve and Value Each Other N/A