Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'feldsteinewing@uri.edu', 'phone': '401-874-4251', 'title': 'Dr. Sarah Feldstein Ewing', 'organization': 'University of Rhode Island'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of participant participation (baseline through 12 month follow up).', 'eventGroups': [{'id': 'EG000', 'title': 'Motivational Interviewing (MI)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brief Adolescent Mindfulness (BAM)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol-related Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing (MI)', 'description': "This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.\n\nMotivational Interviewing (MI): Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change."}, {'id': 'OG001', 'title': 'Brief Adolescent Mindfulness (BAM)', 'description': "This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.\n\nBrief Adolescent Mindfulness (BAM): Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences."}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0173', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'At 12 month follow up.', 'groupDescription': 'We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported', 'description': 'Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth with full problem drinking data at all follow up time points were included in treatment outcome analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motivational Interviewing (MI)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.'}, {'id': 'FG001', 'title': 'Brief Adolescent Mindfulness (BAM)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.'}], 'periods': [{'title': 'Intervention + Baseline Scan', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Unable to adhere to session timeline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '3 Month Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants must have completed baseline scan to be eligible for the 3 Month Follow Up scan', 'groupId': 'FG000', 'numSubjects': '97'}, {'comment': 'Participants must have completed baseline scan to be eligible for the 3 Month Follow Up scan', 'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Moved out of study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Unable to adhere to session timeline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'MRI contraindication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '6 Month Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For analysis purposes, only participants with complete scan data (baseline + 3 Month) were followed', 'groupId': 'FG000', 'numSubjects': '81'}, {'comment': 'For analysis purposes, only participants with complete scan data (baseline + 3 Month) were followed', 'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '12 Month Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For analysis purposes, only participants with complete scan data (baseline + 3 Month) were followed', 'groupId': 'FG000', 'numSubjects': '81'}, {'comment': 'For analysis purposes, only participants with complete scan data (baseline + 3 Month) were followed', 'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Motivational Interviewing (MI)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.'}, {'id': 'BG001', 'title': 'Brief Adolescent Mindfulness (BAM)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.83', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '18.54', 'spread': '1.08', 'groupId': 'BG001'}, {'value': '18.68', 'spread': '1.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated using date of birth and baseline visit date.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Genderqueer / Gender neutral', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Transgender', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol-related Problems', 'classes': [{'categories': [{'measurements': [{'value': '8.98', 'spread': '13.08', 'groupId': 'BG000'}, {'value': '6.13', 'spread': '6.60', 'groupId': 'BG001'}, {'value': '7.54', 'spread': '10.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Rutgers Alcohol Problem Index (RAPI) is a 23 item measure scored on a 5 point Likert scale. Values are sum scores (no reverse coded items). Possible range is 0 - 92, with higher scores indicating greater endorsement of alcohol related problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-03', 'size': 3879986, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-09T12:46', 'hasProtocol': True}, {'date': '2018-10-03', 'size': 709669, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-27T11:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2017-11-29', 'resultsFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-09', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol-related Problems', 'timeFrame': 'assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported', 'description': 'Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '36166981', 'type': 'DERIVED', 'citation': 'Dash GF, Chung T, Yang M, Bryan AD, Hudson KA, Feldstein Ewing SW. Examining the influence of adolescent:provider alliance on youth hazardous drinking: Findings from a randomized controlled trial. Addict Behav. 2023 Jan;136:107499. doi: 10.1016/j.addbeh.2022.107499. Epub 2022 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within the specified age range\n* \\>= 1 past two month binge drinking episode\n* right-handed\n* proficient in English\n* agree to be contacted for the 3, 6, and 12 month follow ups\n* informed consent of a parent/guardian, if under 18 years old\n* informed assent/consent of participating youth\n\nExclusion Criteria:\n\n* \\> 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)\n* evidence of brain injury/illness or neurological disorder including psychosis\n* lifetime loss of consciousness \\>= 2 min\n* unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) contraindications (e.g., pregnancy)'}, 'identificationModule': {'nctId': 'NCT03367858', 'acronym': 'MINA', 'briefTitle': 'Motivational Interviewing and Neuroimaging With Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Rhode Island'}, 'officialTitle': 'Motivational Interviewing and Neuroimaging With Adolescents', 'orgStudyIdInfo': {'id': '5R01AA023658', 'link': 'https://reporter.nih.gov/quickSearch/5R01AA023658', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing (MI)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.', 'interventionNames': ['Behavioral: Motivational Interviewing (MI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Adolescent Mindfulness (BAM)', 'description': 'This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.', 'interventionNames': ['Behavioral: Brief Adolescent Mindfulness (BAM)']}], 'interventions': [{'name': 'Motivational Interviewing (MI)', 'type': 'BEHAVIORAL', 'description': "Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change.", 'armGroupLabels': ['Motivational Interviewing (MI)']}, {'name': 'Brief Adolescent Mindfulness (BAM)', 'type': 'BEHAVIORAL', 'description': "Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences.", 'armGroupLabels': ['Brief Adolescent Mindfulness (BAM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Sarah Feldstein Ewing, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rhode Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rhode Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sarah Feldstein Ewing', 'investigatorAffiliation': 'University of Rhode Island'}}}}