Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 4:04 AM
Study NCT ID:
NCT01797835
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
Sponsor:
Organization:
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'damico@rand.org', 'phone': '3103930411', 'title': "Dr. Elizabeth D'Amico", 'phoneExt': '6487', 'organization': 'RAND'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Adverse Event (AE): any untoward medical occurrence that may present itself during treatment or administration of an intervention, and which may or may not have a causal relationship with the treatment. Adverse events could arise from the study (e.g., breach of confidentiality) or could arise due to the population under study (e.g., a youth reports extensive use of drugs or that he/she "huffs" daily).', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.\n\nusual care: Youth receive a brochure with information on AOD use.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 0, 'seriousNumAtRisk': 141, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CHAT Brief MI Intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.\n\nCHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Times Used Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.\n\nusual care: Youth receive a brochure with information on AOD use.'}, {'id': 'OG001', 'title': 'CHAT Brief MI Intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.\n\nCHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.64', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '5.18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Past 3 months', 'description': 'in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Times Used Marijuana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.\n\nusual care: Youth receive a brochure with information on AOD use.'}, {'id': 'OG001', 'title': 'CHAT Brief MI Intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.\n\nCHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.95', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '6.38', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Past 3 months', 'description': 'number of times used marijuana in the past 3 months; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHAT Brief MI Intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.\n\nCHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.\n\nusual care: Youth receive a brochure with information on AOD use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'preAssignmentDetails': 'this study included an examination of screening; thus, not all youth were part of the randomized controlled trial as they screened in at low risk. This is why there is a larger N for the overall sample. The 294 are the youth that screened in as at-risk who were then part of the RCT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CHAT Brief MI Intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.\n\nCHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.\n\nusual care: Youth receive a brochure with information on AOD use.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.16', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '15.91', 'spread': '1.61', 'groupId': 'BG001'}, {'value': '16', 'spread': '1.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'asked how old they were', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '99', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-22', 'size': 293519, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-31T18:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2013-02-21', 'resultsFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-31', 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Times Used Alcohol', 'timeFrame': 'Past 3 months', 'description': 'in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).'}], 'secondaryOutcomes': [{'measure': 'Number of Times Used Marijuana', 'timeFrame': 'Past 3 months', 'description': 'number of times used marijuana in the past 3 months; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adolescents', 'intervention', 'motivational interviewing', 'alcohol and drug use'], 'conditions': ['Alcohol Use', 'Drug Use']}, 'referencesModule': {'references': [{'pmid': '31296568', 'type': 'DERIVED', 'citation': "D'Amico EJ, Parast L, Osilla KC, Seelam R, Meredith LS, Shadel WG, Stein BD. Understanding Which Teenagers Benefit Most From a Brief Primary Care Substance Use Intervention. Pediatrics. 2019 Aug;144(2):e20183014. doi: 10.1542/peds.2018-3014. Epub 2019 Jul 11."}, {'pmid': '30861475', 'type': 'DERIVED', 'citation': "Meredith LS, Seelam R, Stein BD, Parast L, Shadel WG, D'Amico EJ. Adolescents with better mental health have less problem alcohol use six months later. Addict Behav. 2019 Aug;95:77-81. doi: 10.1016/j.addbeh.2019.03.006. Epub 2019 Mar 7."}, {'pmid': '30138016', 'type': 'DERIVED', 'citation': "D'Amico EJ, Parast L, Shadel WG, Meredith LS, Seelam R, Stein BD. Brief motivational interviewing intervention to reduce alcohol and marijuana use for at-risk adolescents in primary care. J Consult Clin Psychol. 2018 Sep;86(9):775-786. doi: 10.1037/ccp0000332."}, {'pmid': '29316897', 'type': 'DERIVED', 'citation': "Meredith LS, Ewing BA, Stein BD, Shadel WG, Brooks Holliday S, Parast L, D'Amico EJ. Influence of mental health and alcohol or other drug use risk on adolescent reported care received in primary care settings. BMC Fam Pract. 2018 Jan 9;19(1):10. doi: 10.1186/s12875-017-0689-y."}, {'pmid': '27940696', 'type': 'DERIVED', 'citation': "D'Amico EJ, Parast L, Meredith LS, Ewing BA, Shadel WG, Stein BD. Screening in Primary Care: What Is the Best Way to Identify At-Risk Youth for Substance Use? Pediatrics. 2016 Dec;138(6):e20161717. doi: 10.1542/peds.2016-1717. Epub 2016 Nov 18."}]}, 'descriptionModule': {'briefSummary': 'Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care. The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: 1\n\n* 12-18\n* speak English\n\nExclusion Criteria:\n\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT01797835', 'briefTitle': 'Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': 'Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care', 'orgStudyIdInfo': {'id': '1R01AA021786', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA021786', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': 'Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.', 'interventionNames': ['Behavioral: usual care']}, {'type': 'EXPERIMENTAL', 'label': 'CHAT brief MI intervention', 'description': 'Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.', 'interventionNames': ['Behavioral: CHAT brief MI intervention']}], 'interventions': [{'name': 'CHAT brief MI intervention', 'type': 'BEHAVIORAL', 'description': 'CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.', 'armGroupLabels': ['CHAT brief MI intervention']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'Youth receive a brochure with information on AOD use.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91605', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Valley Community Clinic', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '15215', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC St. Margaret', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': "Elizabeth J D'Amico, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'collaborators': [{'name': 'Valley Community Clinic', 'class': 'UNKNOWN'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}