Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-08 @ 12:23 PM
Study NCT ID:
NCT03051633
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Substance Use Prevention Campaign for American Indian Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'meghan.crabtree@colostate.edu', 'phone': '2105875584', 'title': 'Dr. Meghan Crabtree', 'organization': 'Colorado State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign', 'otherNumAtRisk': 342, 'deathsNumAtRisk': 342, 'otherNumAffected': 0, 'seriousNumAtRisk': 342, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Assessment only', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign'}, {'id': 'OG001', 'title': 'Control', 'description': 'Assessment only'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.714', 'ciUpperLimit': '-0.126', 'groupDescription': 'Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.', 'nonInferiorityComment': 'Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'The number of students who self-reported initiated alcohol for the first time during the study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).'}, {'type': 'PRIMARY', 'title': 'Alcohol Intoxication Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign'}, {'id': 'OG001', 'title': 'Control', 'description': 'Assessment only'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.037', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.762', 'ciUpperLimit': '-0.018', 'groupDescription': 'Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.', 'nonInferiorityComment': 'Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Number of participants self-reporting first-time alcohol intoxication initiation during the study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).'}, {'type': 'PRIMARY', 'title': 'Marijuana Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign'}, {'id': 'OG001', 'title': 'Control', 'description': 'Assessment only'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.104', 'ciUpperLimit': '0.444', 'groupDescription': 'Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.', 'nonInferiorityComment': 'Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Number of participants who self-reported first-time marijuana use initiation during the study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign'}, {'id': 'FG001', 'title': 'Control', 'description': 'Assessment only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign\n\nBe Under Your Own Influence: School based anti-drug use communications campaign'}, {'id': 'BG001', 'title': 'Control', 'description': 'Assessment only'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '.57', 'groupId': 'BG000'}, {'value': '12.5', 'spread': '.65', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age not reported by respondent.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex data was not given by the respondent.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '321', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-21', 'size': 172112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-21T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2017-02-08', 'resultsFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-20', 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Initiation', 'timeFrame': '18 months', 'description': 'The number of students who self-reported initiated alcohol for the first time during the study period'}, {'measure': 'Alcohol Intoxication Initiation', 'timeFrame': '18 months', 'description': 'Number of participants self-reporting first-time alcohol intoxication initiation during the study period.'}, {'measure': 'Marijuana Initiation', 'timeFrame': '18 months', 'description': 'Number of participants who self-reported first-time marijuana use initiation during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Substance Use']}, 'descriptionModule': {'briefSummary': "The goal of this project is to test the effectiveness of a successful anti-drug communications campaign (Be Under your Own Influence) to lower substance use among AI 7th graders. The campaign uses messages that support youths' personal autonomy and future aspirations, and these messages are delivered to 7th graders using high school students. Our goal is to develop a turnkey package for the broader population of AI youth and schools and to develop components that can incorporate flexibility and creativity in their delivery.", 'detailedDescription': 'Substance use is a particularly dangerous risk to middle-school youth, and American Indian (AI) youth are at increased risk. We have found over the course of more than three decades that substance use among AI youth is consistently higher than that of other ethnic/racial groups.\n\nSchools are often the site for adolescent drug prevention efforts, but results from these efforts are often modest or even disappointing. This intervention adapts an existing campaign (Be Under Your Own Influence; BUYOI) that has been found to be effective in reducing substance use and that uses campaign messages that are congruent with AI culture. The intervention will be adapted using significant contributions from tribal members, including youth, teachers, parents, elders, and other community members. This proposal includes active involvement of local advisory boards, hiring of a local AI liaison, focus groups, a youth photo voice component, and use of AI staff from our Center and from the Native American Cultural Center at our university.\n\nThe adapted anti-drug and alcohol use communications campaign will be delivered by selected high school students to 7th grade students. A distinguishing feature of the BUYOI campaign is a message that targets outcome expectations related to aspirations, autonomy, and physical harms. The campaign will use multiple channels of communication including print (e.g., posters and fliers), video and audio spots, presentations, and social media to deliver messages that are designed to alter outcome expectancies, intentions, and ultimately substance use among targeted youth.\n\nThe campaign will be delivered to two cohorts of 7th graders, with 4 longitudinal measurement occasions for each cohort. Five middle schools (and their corresponding high schools) have been recruited for the study, where three of these will be randomly assigned to the intervention condition and two to the control condition. Multilevel data analysis will test for effects of campaign exposure on autonomy, aspirations, perceived harm, and intentions to use.\n\nBecause of the heavy involvement of the school and community in the development and delivery of the intervention, we will be able to incorporate sustainability into the design of all integrated components. Ultimately, our goal is to develop a turnkey package for the broader population of reservation-based AI youth and schools and to develop components that can incorporate flexibility and creativity in their delivery. For example, a school or local group may implement the campaign in its original form or they may modify aspects to make them more pertinent to their community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent\n\nExclusion Criteria:\n\n* No parental consent'}, 'identificationModule': {'nctId': 'NCT03051633', 'briefTitle': 'Substance Use Prevention Campaign for American Indian Youth', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Substance Use Prevention Campaign for American Indian Youth', 'orgStudyIdInfo': {'id': 'R01DA035141', 'link': 'https://reporter.nih.gov/quickSearch/R01DA035141', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Be Under Your Own Influence Intervention', 'description': 'School-based anti-substance use communications campaign', 'interventionNames': ['Behavioral: Be Under Your Own Influence']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Assessment only'}], 'interventions': [{'name': 'Be Under Your Own Influence', 'type': 'BEHAVIORAL', 'description': 'School based anti-drug use communications campaign', 'armGroupLabels': ['Be Under Your Own Influence Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Scientist', 'investigatorFullName': 'Randall Swaim', 'investigatorAffiliation': 'Colorado State University'}}}}