Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT01170260
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012723', 'term': 'Sex'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hkhawaja@salud.unm.edu', 'phone': '505-272-7028', 'title': 'Hadya Khawaja', 'organization': 'University of New Mexico Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Every 3 months for 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized to Alcohol Content', 'description': 'Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments).', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sex Plus Alcohol Risk Reduction', 'description': 'Corresponding intervention gives info focusing on sex and alcohol risk reduction only\n\nSEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 0, 'seriousNumAtRisk': 155, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sexual + Alcohol + Cannabis Content', 'description': 'Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction\n\nSEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Risky Sexual Behavior Measured for 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized to Alcohol Content', 'description': 'Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments).'}, {'id': 'OG001', 'title': 'Sex Plus Alcohol Risk Reduction', 'description': 'Corresponding intervention gives info focusing on sex and alcohol risk reduction only\n\nSEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio'}, {'id': 'OG002', 'title': 'Sexual + Alcohol + Cannabis Content', 'description': 'Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction\n\nSEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized to Alcohol Content', 'description': 'Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments).'}, {'id': 'FG001', 'title': 'Sex Plus Alcohol Risk Reduction', 'description': 'Corresponding intervention gives info focusing on sex and alcohol risk reduction only\n\nSEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio'}, {'id': 'FG002', 'title': 'Sexual + Alcohol + Cannabis Content', 'description': 'Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction\n\nSEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '460', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Info-only Sexual Risk Reduction', 'description': 'Corresponding intervention gives information only on STDs/HIV\n\nINFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY): Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion'}, {'id': 'BG001', 'title': 'Sex Plus Alcohol Risk Reduction', 'description': 'Corresponding intervention gives info focusing on sex and alcohol risk reduction only\n\nSEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion'}, {'id': 'BG002', 'title': 'Sex + Alcohol + Marijuana Risk Reduction', 'description': 'Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction\n\nSEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.85', 'groupId': 'BG000', 'lowerLimit': '15.7', 'upperLimit': '16'}, {'value': '15.82', 'groupId': 'BG001', 'lowerLimit': '15.6', 'upperLimit': '16'}, {'value': '15.78', 'groupId': 'BG002', 'lowerLimit': '15.6', 'upperLimit': '16'}, {'value': '15.81', 'groupId': 'BG003', 'lowerLimit': '15.6', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '460', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2010-07-23', 'resultsFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-01', 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Risky Sexual Behavior Measured for 1 Year', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Risk Reduction Behavior', 'Health Behavior', 'Sexual Behavior', 'Adolescent Behavior', 'Cannabis']}, 'referencesModule': {'references': [{'pmid': '33341180', 'type': 'DERIVED', 'citation': 'Schmiege SJ, Magnan RE, Yeater EA, Feldstein Ewing SW, Bryan AD. Randomized Trial to Reduce Risky Sexual Behavior Among Justice-Involved Adolescents. Am J Prev Med. 2021 Jan;60(1):47-56. doi: 10.1016/j.amepre.2020.07.009.'}, {'pmid': '29435591', 'type': 'DERIVED', 'citation': 'Bryan AD, Magnan RE, Gillman AS, Yeater EA, Feldstein Ewing SW, Kong AS, Schmiege SJ. Effect of Including Alcohol and Cannabis Content in a Sexual Risk-Reduction Intervention on the Incidence of Sexually Transmitted Infections in Adolescents: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 Apr 2;172(4):e175621. doi: 10.1001/jamapediatrics.2017.5621. Epub 2018 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.', 'detailedDescription': 'During baseline assessment, a computer questionnaire is administered, including questions about participants\' attitudes, beliefs, and behaviors regarding sexual behavior, condom use, and drug use. A saliva sample is provided as well. A "Time-Line Follow-Back" is conducted, noting on which days certain activities occurred, such as sexual intercourse, alcohol use, marijuana use, and cigarette use. A urine sample is also collected in order to test for the STD\'s chlamydia and gonorrhea (if results are positive, we schedule a meeting with the participant to administer medication to treat the STD).\n\nIn the second session, a 3-hour interventional health class is held with groups of same-gender participants. There are 3 different health classes (one focusing just on sex risk reduction, one focusing on sex and alcohol risk reduction, and one focusing on sex, alcohol, and marijuana risk reduction); participants are randomly assigned to one.\n\nParticipants are contacted 3 months after the intervention, 6 months after, 9 months after, and 12 months after, in order to meet. These meetings entail completing another Time-Line Follow-Back and completing another questionnaire. At the final 12 month meeting, we collect another urine sample to again test for chlamydia and gonorrhea. As before, if results are positive, we schedule a meeting with the participant to administer medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 14-18\n* Involved in Juvenile Justice System (living in the Detention Center when recruited)\n\nExclusion Criteria:\n\n* Currently taking anti-psychotics\n* Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)'}, 'identificationModule': {'nctId': 'NCT01170260', 'acronym': 'MARS', 'briefTitle': 'Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents', 'orgStudyIdInfo': {'id': 'NIAAA RO1 AA013844-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Info-only sexual risk reduction', 'description': 'Corresponding intervention gives information only on STDs/HIV', 'interventionNames': ['Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)']}, {'type': 'EXPERIMENTAL', 'label': 'Sex plus alcohol risk reduction', 'description': 'Corresponding intervention gives info focusing on sex and alcohol risk reduction only', 'interventionNames': ['Behavioral: SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)']}, {'type': 'EXPERIMENTAL', 'label': 'Sex + alcohol + marijuana risk reduction', 'description': 'Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction', 'interventionNames': ['Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION']}], 'interventions': [{'name': 'INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)', 'type': 'BEHAVIORAL', 'otherNames': ['INFO-ONLY'], 'description': 'Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion', 'armGroupLabels': ['Info-only sexual risk reduction']}, {'name': 'SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)', 'type': 'BEHAVIORAL', 'otherNames': ['(SRRI+ETOH)'], 'description': 'Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion', 'armGroupLabels': ['Sex plus alcohol risk reduction']}, {'name': 'SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION', 'type': 'BEHAVIORAL', 'otherNames': ['(SRRI+ETOH+THC)'], 'description': 'Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion', 'armGroupLabels': ['Sex + alcohol + marijuana risk reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87107', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Juvenile Detention Center (JDC)', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}