Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01372033
Status:
COMPLETED
Last Update Posted:
2011-06-13
First Post:
2011-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Manualized Treatment in a Seamless System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-10', 'studyFirstSubmitDate': '2011-06-10', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrest', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Treatment Completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug treatment', 'substance abuse', 'offenders', 'high risk'], 'conditions': ['Substance Abuse', 'Offenders', 'Criminal Thinking', 'HIV Risk Behaviors']}, 'descriptionModule': {'briefSummary': 'The specific aims of this project are:\n\n1. To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders;\n2. To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level;\n3. To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and\n4. To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Substance abusers\n\n * men and women\n * treatment\n\nExclusion Criteria:\n\n* Parolees\n\n * Low threshold substance abuse\n * violent offenders'}, 'identificationModule': {'nctId': 'NCT01372033', 'acronym': 'Man Tx', 'briefTitle': 'Effects of Manualized Treatment in a Seamless System', 'organization': {'class': 'OTHER', 'fullName': 'George Mason University'}, 'officialTitle': 'Effects of Manualized Treatment in a Seamless System of Care: Handling Probation', 'orgStudyIdInfo': {'id': 'R01DA017729', 'link': 'https://reporter.nih.gov/quickSearch/R01DA017729', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA017729', 'link': 'https://reporter.nih.gov/quickSearch/R01DA017729', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT', 'description': 'Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '18 sessions of CBT, twice weekly', 'armGroupLabels': ['CBT']}, {'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '18 sessions with goals groups drug testing', 'armGroupLabels': ['CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21221', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Dvision of Parole and Probation', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Faye S Taxman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Mason University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Faye S Taxman, Ph.D., Univeristy Professor', 'oldOrganization': 'George Mason University'}}}}