Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 9:19 PM
Study NCT ID:
NCT01356667
Status:
TERMINATED
Last Update Posted:
2018-06-28
First Post:
2011-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drum-Assisted Therapy for Native Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniel.dickerson@ucla.edu', 'phone': '562-277-0310', 'title': 'Dr. Daniel Dickerson', 'organization': 'UCLA, Integrated Substance Abuse Programs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received at United American Indian Involvement (UAII)', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Drum-Assisted Recovery Therapy for Native Americans', 'description': '12-week treatment protocol consisting of drum therapy for Native Americans', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drug and Alcohol Use as a Measure of Treatment Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received at United American Indian Involvement (UAII)'}, {'id': 'OG001', 'title': 'Drum-Assisted Recovery Therapy for Native Americans', 'description': '12-week treatment protocol consisting of drum therapy for Native Americans'}], 'timeFrame': 'Change from Baseline in Drug and Alcohol use at 6 months', 'description': 'Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.', 'reportingStatus': 'POSTED', 'populationDescription': 'Please be advised that this clincial trial was terminated prior to finalization of any research procedures.'}, {'type': 'SECONDARY', 'title': 'Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received at United American Indian Involvement (UAII)'}, {'id': 'OG001', 'title': 'Drum-Assisted Recovery Therapy for Native Americans', 'description': '12-week treatment protocol consisting of drum therapy for Native Americans'}], 'timeFrame': 'Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks', 'description': "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.", 'reportingStatus': 'POSTED', 'populationDescription': 'Please be advised that this clincial trial was terminated prior to finalization of any research procedures.'}, {'type': 'SECONDARY', 'title': 'Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received\n\nTreatment-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.'}, {'id': 'OG001', 'title': 'DARTNA', 'description': '12-week DARTNA program\n\nDARTNA: 3-hour protocol provided 2x/week over 12 weeks'}], 'timeFrame': 'Change from Baseline in Mental Health and psychosocial characteristics at 6 months', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Please be advised that this clincial trial was terminated prior to finalization of any research procedures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received at United American Indian Involvement (UAII)'}, {'id': 'FG001', 'title': 'Drum-Assisted Recovery Therapy for Native Americans', 'description': '12-week treatment protocol consisting of drum therapy for Native Americans'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The recruitment period lasted from Sept, 2011-August 2012 and took place at United American Indian Involvement, Inc.', 'preAssignmentDetails': 'No enrolled participants were excluded from the trial before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received at United American Indian Involvement (UAII)'}, {'id': 'BG001', 'title': 'Drum-Assisted Recovery Therapy for Native Americans', 'description': '12-week treatment protocol consisting of drum therapy for Native Americans'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Study period is over and recruitment was stopped due to time constraints.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-06', 'studyFirstSubmitDate': '2011-04-26', 'resultsFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-04', 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug and Alcohol Use as a Measure of Treatment Effectiveness', 'timeFrame': 'Change from Baseline in Drug and Alcohol use at 6 months', 'description': 'Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.'}], 'secondaryOutcomes': [{'measure': 'Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension', 'timeFrame': 'Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks', 'description': "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."}, {'measure': 'Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.', 'timeFrame': 'Change from Baseline in Mental Health and psychosocial characteristics at 6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['American Indians', 'Native Americans', 'substance abuse', 'culture'], 'conditions': ['Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '32720004', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR; American Psychiatric Association, 2000) criteria of current alcohol or drug abuse or dependence\n* self-identifying as at least ΒΌ American Indian/Alaska Native heritage\n* seeking treatment for alcohol or drug abuse\n* being at least 18 years old. Clients will be assessed for suitability for outpatient treatment.\n\nExclusion Criteria:\n\n* 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)\n* have a current suicidal ideation/plan as assessed by the ASI or BSI\n* 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\n* expectation that the participant will fail to complete the study protocol due to probable incarceration or relocation from the clinic area.'}, 'identificationModule': {'nctId': 'NCT01356667', 'briefTitle': 'Drum-Assisted Therapy for Native Americans', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Drum-Assisted Recovery Therapy for Native Americans', 'orgStudyIdInfo': {'id': 'DARTNA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-As-Usual', 'description': 'Substance Abuse treatment typically received', 'interventionNames': ['Behavioral: Treatment-As-Usual']}, {'type': 'EXPERIMENTAL', 'label': 'DARTNA', 'description': '12-week DARTNA program', 'interventionNames': ['Behavioral: DARTNA']}], 'interventions': [{'name': 'DARTNA', 'type': 'BEHAVIORAL', 'description': '3-hour protocol provided 2x/week over 12 weeks', 'armGroupLabels': ['DARTNA']}, {'name': 'Treatment-As-Usual', 'type': 'BEHAVIORAL', 'description': 'Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.', 'armGroupLabels': ['Treatment-As-Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'United American Indian Involvement, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Daniel L Dickerson, D.O., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Psychiatrist', 'investigatorFullName': 'Daniel Dickerson', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}