Trial Outcomes & Findings for Drum-Assisted Therapy for Native Americans (NCT NCT01356667)

Results Overview

Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Change from Baseline in Drug and Alcohol use at 6 months

Results posted on

2018-06-28

Participant Flow

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

No enrolled participants were excluded from the trial before assignment to groups.

Participant milestones

Participant milestones
Measure	Treatment-As-Usual Substance Abuse treatment typically received at United American Indian Involvement (UAII)	Drum-Assisted Recovery Therapy for Native Americans 12-week treatment protocol consisting of drum therapy for Native Americans
Overall Study STARTED	4	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drum-Assisted Therapy for Native Americans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment-As-Usual n=4 Participants Substance Abuse treatment typically received at United American Indian Involvement (UAII)	Drum-Assisted Recovery Therapy for Native Americans n=6 Participants 12-week treatment protocol consisting of drum therapy for Native Americans	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.3 years STANDARD_DEVIATION 9.0 • n=5 Participants	50.3 years STANDARD_DEVIATION 3.9 • n=7 Participants	44.3 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline in Drug and Alcohol use at 6 months

Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.

Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks

Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline in Mental Health and psychosocial characteristics at 6 months

Population: Please be advised that this clincial trial was terminated prior to finalization of any research procedures.

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment-As-Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drum-Assisted Recovery Therapy for Native Americans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Dickerson

UCLA, Integrated Substance Abuse Programs

Phone: 562-277-0310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place