Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 7:20 AM
Study NCT ID:
NCT01143792
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2010-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Treatments for Homeless Youths
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'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': 'slesnick.5@osu.edu', 'phone': '614 247-8469', 'title': 'Natasha Slesnick', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Overall Study', 'description': 'Adverse events were monitored but none were observed.', 'eventGroups': [{'id': 'EG000', 'title': 'CRA + HIV Prevention', 'description': 'Treatment included twelve 1-hour sessions for a total of 14 sessions.', 'otherNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MET + HIV Prevention', 'description': 'Treatment included two 1-hour MI sessions for a total of 4 sessions', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Case Management + HIV Prevention', 'description': 'Treatment included twelve 1-hour sessions for a total of 14 sessions.', 'otherNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.'}, {'id': 'OG001', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.'}, {'id': 'OG002', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.67', 'spread': '43.24', 'groupId': 'OG000'}, {'value': '53.60', 'spread': '40.76', 'groupId': 'OG001'}, {'value': '49.38', 'spread': '40.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Three months', 'description': 'Percentage of substance use days in prior three months.', 'unitOfMeasure': 'percent days of drug use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'HIV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three months', 'description': 'Frequency of condoms use in prior three months.', 'unitOfMeasure': 'participants who always used condom', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'HIV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six months', 'description': 'Frequency of condoms use in prior three months.', 'unitOfMeasure': 'participants who always used condoms', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'HIV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Twelve months', 'description': 'Frequency of condoms use in prior six months.', 'unitOfMeasure': 'participants who always used condoms', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.63', 'spread': '9.57', 'groupId': 'OG000'}, {'value': '14.78', 'spread': '14.83', 'groupId': 'OG001'}, {'value': '10.97', 'spread': '12.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Three months', 'description': 'Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.02', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '11.97', 'spread': '14.13', 'groupId': 'OG001'}, {'value': '8.76', 'spread': '10.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG001', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'id': 'OG002', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.70', 'spread': '11.09', 'groupId': 'OG000'}, {'value': '12.07', 'spread': '12.13', 'groupId': 'OG001'}, {'value': '8.48', 'spread': '10.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twelve months', 'description': 'Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}, {'id': 'OG001', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}, {'id': 'OG002', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.10', 'spread': '38.83', 'groupId': 'OG000'}, {'value': '48.88', 'spread': '41.43', 'groupId': 'OG001'}, {'value': '42.64', 'spread': '40.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'Percentage of substance use days in prior three months', 'unitOfMeasure': 'percent days of drug use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MET + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}, {'id': 'OG001', 'title': 'Case Management + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}, {'id': 'OG002', 'title': 'CRA + HIV Prevention', 'description': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.25', 'spread': '41.55', 'groupId': 'OG000'}, {'value': '44.33', 'spread': '39.31', 'groupId': 'OG001'}, {'value': '38.46', 'spread': '39.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twelve months', 'description': 'Percentage of substance use days in prior six months', 'unitOfMeasure': 'percent days of drug use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CRA + HIV Prevention', 'description': 'Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.'}, {'id': 'FG001', 'title': 'MET + HIV Prevention', 'description': 'Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.'}, {'id': 'FG002', 'title': 'Case Management + HIV Prevention', 'description': 'Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment ended on time, recruitment completed as proposed.', 'preAssignmentDetails': 'intent to treat design used.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CRA + HIV Prevention', 'description': 'Treatment included twelve 1-hour sessions for a total of 14 sessions.'}, {'id': 'BG001', 'title': 'MET + HIV Prevention', 'description': 'Treatment included two 1-hour MI sessions for a total of 4 sessions'}, {'id': 'BG002', 'title': 'Case Management + HIV Prevention', 'description': 'Treatment included twelve 1-hour sessions for a total of 14 sessions.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.70', 'spread': '1.34', 'groupId': 'BG000'}, {'value': '18.69', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '18.84', 'spread': '1.11', 'groupId': 'BG002'}, {'value': '18.7', 'spread': '1.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "The number of participants in each group varies because the urn randomization program didn't balance the groups equally."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2010-06-11', 'resultsFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-12', 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance Use', 'timeFrame': 'Three months', 'description': 'Percentage of substance use days in prior three months.'}, {'measure': 'Substance Use', 'timeFrame': 'Six months', 'description': 'Percentage of substance use days in prior three months'}, {'measure': 'Substance Use', 'timeFrame': 'Twelve months', 'description': 'Percentage of substance use days in prior six months'}], 'secondaryOutcomes': [{'measure': 'HIV Risk', 'timeFrame': 'Three months', 'description': 'Frequency of condoms use in prior three months.'}, {'measure': 'HIV Risk', 'timeFrame': 'Six months', 'description': 'Frequency of condoms use in prior three months.'}, {'measure': 'HIV Risk', 'timeFrame': 'Twelve months', 'description': 'Frequency of condoms use in prior six months.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Three months', 'description': 'Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Six months', 'description': 'Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Twelve months', 'description': 'Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Substance abuse', 'Homelessness', 'HIV risk behavior'], 'conditions': ['Substance Abuse']}, 'descriptionModule': {'briefSummary': 'Youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population. Studies document high rates of substance use, HIV risk, mental health problems, teenage pregnancy and criminality. Research to date examining homeless, street living youth has been primarily descriptive; less effort has been directed towards developing and evaluating treatment interventions for this group. The majority of homeless youth do not receive substance abuse treatment, with one study reporting that only 15% of street living youth report ever receiving mental health services. The effectiveness of the Community Reinforcement Approach (CRA) with street living youth was studied in our recently completed Stage 1 trial. The proposed study is a Stage II clinical trial examining outcome of CRA individual therapy as compared to two interventions commonly employed, yet little researched, with this group. All clients will be randomized to one of three theoretically distinct interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case Management (CM). The relative effectiveness of these interventions will be evaluated at 3, 6, and 12 months post-baseline. The Social Ecology Theory of Development (Bronfenbrenner, 1979) guides our change hypotheses and intervention. Proposed change mechanisms (mediators) for each intervention will be evaluated. Differential treatment response as a function of ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to better understand the interventions. The study will also examine how, if at all, treatment engagement, retention and expectations impact youth response to the three treatments. Information gained through this project may help address the gap in our understanding of how best to effectively intervene with a group at high risk for continuing health and psychological problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Youth are between the ages of 14-20.\n2. Youth have plans to remain in the Columbus areas for at least 12 months.\n3. Youth meets abuse or dependence DSM-IV criteria for Psychoactive Substance Use or Alcohol disorder, as assessed by the computerized diagnostic interview schedule for children (CDISC, Shaffer, 1992).\n4. Youth agrees to participate in the assessment and treatment intervention.\n5. Youth meets criteria for homelessness as defined by DHHS.\n\nExclusion Criteria:\n\n1\\. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).'}, 'identificationModule': {'nctId': 'NCT01143792', 'briefTitle': 'Evaluation of Treatments for Homeless Youths', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management', 'orgStudyIdInfo': {'id': '2005B0078'}, 'secondaryIdInfos': [{'id': 'R01DA013549', 'link': 'https://reporter.nih.gov/quickSearch/R01DA013549', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRA + HIV prevention', 'interventionNames': ['Behavioral: Community Reinforcement Approach (CRA) + HIV prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Case Management + HIV prevention', 'interventionNames': ['Behavioral: Case Management + HIV Prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MET + HIV prevention', 'interventionNames': ['Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention']}], 'interventions': [{'name': 'Community Reinforcement Approach (CRA) + HIV prevention', 'type': 'BEHAVIORAL', 'description': '12 sessions of the CRA and 2 sessions of HIV prevention.', 'armGroupLabels': ['CRA + HIV prevention']}, {'name': 'Case Management + HIV Prevention', 'type': 'BEHAVIORAL', 'description': '12 sessions of case management and 2 sessions of HIV prevention.', 'armGroupLabels': ['Case Management + HIV prevention']}, {'name': 'Motivational Enhancement Therapy (MET) + HIV prevention', 'type': 'BEHAVIORAL', 'description': '2 sessions of MET and 2 sessions of HIV prevention.', 'armGroupLabels': ['MET + HIV prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Natasha Slesnick, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Natasha Slesnick', 'investigatorAffiliation': 'Ohio State University'}}}}