Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-24 @ 11:26 PM
Study NCT ID:
NCT01532934
Status:
COMPLETED
Last Update Posted:
2016-12-12
First Post:
2012-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000987', 'term': 'Antisocial Personality Disorder'}, {'id': 'D000075665', 'term': 'Recidivism'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D000066479', 'term': 'Criminal Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marc_swogger@urmc.rochester.edu', 'phone': '585-275-7418', 'title': 'Marc T. Swogger, Ph.D.', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Six months from baseline', 'description': 'Criminal recidivism is not considered an adverse event because it is one of the outcome variables. Participants were monitored for serious adverse events through six months of the study (i.e., the last study-related session). There were no adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Brief Motivational Intervention Plus Standard Care', 'description': 'There were no adverse events for members of this group.', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'There were no adverse events for members of this group.', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Days Abstinent Per Month From Drug Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI+SC', 'description': '1. brief MI + standard care\n2. standard care'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Assessment only plus the usual range of pretrial services'}], 'classes': [{'categories': [{'measurements': [{'value': '46.92', 'spread': '37.46', 'groupId': 'OG000'}, {'value': '55.16', 'spread': '42.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.', 'groupDescription': 'A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'three to six months post baseline', 'description': 'Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.', 'unitOfMeasure': 'percentage of days abstinent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.'}, {'type': 'SECONDARY', 'title': 'Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Therapy', 'description': 'motivational enhancement therapy for substance use\n\nmotivational enhancement therapy: Four 45-minute MET sessions'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'standard care\n\nstandard care: standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '10.69', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '15.24', 'spread': '14.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\\<.05.', 'groupDescription': 'Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'six months', 'description': 'A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'New Criminal Charge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI+SC', 'description': '1. brief MI + standard care\n2. standard care'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Assessment only plus the usual range of pretrial services'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.69', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold p\\<.05', 'groupDescription': 'Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'New criminal charge vs. no new criminal charge at follow-up as indicated by county database.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brief Therapy', 'description': 'motivational enhancement therapy for substance use\n\nmotivational enhancement therapy: Four 45-minute MET sessions'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'standard care\n\nstandard care: standard care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'In controlled environment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment took place at a jail diversion program in Upstate NY between 2009 and 2014.', 'preAssignmentDetails': 'Inclusion criteria were harmful substance use in the past 6 months and enrollment in a jail diversion program subsequent to being charged with a crime.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brief Motivational Intervention Plus Standard Care (BMI+SC)', 'description': 'Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial'}, {'id': 'BG001', 'title': 'Standard Care (SC)', 'description': 'Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '10', 'groupId': 'BG000'}, {'value': '33.8', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '68', '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': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', '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': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psychopathy Checklist-Revised - Factor One (F1)', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Psychopathy Checklist - Revised is a valid measure of psychopathy with scores ranging from 0-40 (higher indicating higher levels of psychopathy). Factor One of this scale measures interpersonal and affective psychopathic traits and ranges from 0-16.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants were adults in an urban pretrial jail diversion program in Upstate New York recruited between 2009 and 2014 subsequent to being charged with a crime.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2012-01-31', 'resultsFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-19', 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Days Abstinent Per Month From Drug Use', 'timeFrame': 'three to six months post baseline', 'description': 'Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.'}], 'secondaryOutcomes': [{'measure': 'Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)', 'timeFrame': 'six months', 'description': 'A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.'}, {'measure': 'New Criminal Charge', 'timeFrame': 'one year', 'description': 'New criminal charge vs. no new criminal charge at follow-up as indicated by county database.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['substance use', 'psychopathy', 'motivational enhancement', 'criminal recidivism'], 'conditions': ['Substance Use', 'Psychopathy']}, 'referencesModule': {'references': [{'pmid': '26727409', 'type': 'RESULT', 'citation': 'Swogger MT, Conner KR, Caine ED, Trabold N, Parkhurst MN, Prothero LM, Maisto SA. A test of core psychopathic traits as a moderator of the efficacy of a brief motivational intervention for substance-using offenders. J Consult Clin Psychol. 2016 Mar;84(3):248-58. doi: 10.1037/ccp0000065. Epub 2016 Jan 4.'}], 'seeAlsoLinks': [{'url': 'https://www.urmc.rochester.edu/people/26773384-marc-t-swogger/researchers', 'label': 'PI web page'}]}, 'descriptionModule': {'briefSummary': 'Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are needed. Forensic populations are often viewed with considerable therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and the assessment of individual differences among offenders may provide valuable information that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has emerged as an important personality construct for the understanding of violence and criminal recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and lack of remorse may have negative implications for the efficacy of psychosocial interventions. A foundational premise of the present work is that understanding the moderating role of psychopathic traits on substance use treatment outcomes among offenders is essential to determining what works, and for whom. The current proposal is a Phase II randomized clinical trial that aims to examine the impact of psychopathic traits on the efficacy of a brief substance use intervention for offenders in a jail diversion program. Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based treatment will reduce substance use and related consequences relative to a Standard Care only condition, 2) that the reduction in substance use in the intervention group will mediate a reduction in later criminal recidivism relative to the Standard Care condition, and 3) that core psychopathic traits will moderate the efficacy of the intervention such that individuals with lower levels of these traits will derive greater benefits with regard to decreased substance use, decreased drug use consequences, and decreased criminal recidivism at a one-year follow-up.', 'detailedDescription': 'Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are needed. Forensic populations are often viewed with considerable therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and the assessment of individual differences among offenders may provide valuable information that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has emerged as an important personality construct for the understanding of violence and criminal recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and lack of remorse may have negative implications for the efficacy of psychosocial interventions. A foundational premise of the present work is that understanding the moderating role of psychopathic traits on substance use treatment outcomes among offenders is essential to determining what works, and for whom. The current proposal is a Phase II randomized clinical trial that aims to examine the impact of psychopathic traits on the efficacy of a brief substance use intervention for offenders in a jail diversion program. Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based treatment will reduce substance use and related consequences relative to a Standard Care only condition, 2) that the reduction in substance use in the intervention group will mediate a reduction in later criminal recidivism relative to the Standard Care condition, and 3) that core psychopathic traits will moderate the efficacy of the intervention such that individuals with lower levels of these traits will derive greater benefits with regard to decreased substance use, decreased drug use consequences, and decreased criminal recidivism at a one-year follow-up. This work has the potential to provide important data regarding which individuals can benefit from a brief intervention for substance use. Such data will inform the effective and efficient allocation of treatment resources for substance using offenders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In local pretrial services program; English speaking\n\nExclusion Criteria:\n\n* Psychosis, inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01532934', 'briefTitle': 'The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'The Impact of Psychopathic Traits on the Efficacy of a Brief Intervention for Substance Use', 'orgStudyIdInfo': {'id': '28780'}, 'secondaryIdInfos': [{'id': 'K23DA027720', 'link': 'https://reporter.nih.gov/quickSearch/K23DA027720', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brief therapy', 'description': 'motivational enhancement therapy for substance use', 'interventionNames': ['Behavioral: motivational enhancement therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care', 'description': 'standard care', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'motivational enhancement therapy', 'type': 'BEHAVIORAL', 'otherNames': ['SBIRT; brief motivational intervention'], 'description': 'Four 45-minute MET sessions', 'armGroupLabels': ['brief therapy']}, {'name': 'standard care', 'type': 'OTHER', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Pretrial Services, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Marc T. Swogger, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'MarcSwogger', 'investigatorAffiliation': 'University of Rochester'}}}}