Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT02670902
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention for Persons Leaving Residential Substance Abuse Treatment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment', 'timeFrame': 'Baseline', 'description': 'Proportion of participants enrolled in the study as measured by the research records'}, {'measure': 'Change in retention', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Proportion of participants completed the study as measured by the research records'}, {'measure': 'Short-term Relapse', 'timeFrame': '3 months', 'description': 'Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index'}, {'measure': 'Use of aftercare services', 'timeFrame': '3 months', 'description': 'Proportion of participants who were linked to aftercare services (i.e. substance use treatment) at the time of discharge as measured by the Treatment Service Review (TSR)'}, {'measure': 'Housing', 'timeFrame': '3 months', 'description': 'Proportion of participants housed at the time of discharge'}], 'secondaryOutcomes': [{'measure': 'Short-term Social Support', 'timeFrame': '3 months', 'description': 'Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey'}, {'measure': 'Short-term Self-Efficacy', 'timeFrame': '3 months', 'description': 'Level of self-efficacy as measured by "I feel like I\'m in control of my alcohol or drug use."'}, {'measure': 'Short-term Mental Health', 'timeFrame': '3 months', 'description': 'Level of mental health severity as measured by the Brief Symptom Inventory'}, {'measure': 'Change in Relapse', 'timeFrame': '3, 6, and 9 months', 'description': 'Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index'}, {'measure': 'Long-term Relapse', 'timeFrame': '12 months', 'description': 'Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index'}, {'measure': 'Change in Social Support', 'timeFrame': '3, 6, and 9 months', 'description': 'Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey'}, {'measure': 'Long-term Social Support', 'timeFrame': '12 months', 'description': 'Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey'}, {'measure': 'Change in Self-Efficacy', 'timeFrame': '3, 6, and 9 months', 'description': 'Level of self-efficacy as measured by "I feel like I\'m in control of my alcohol or drug use."'}, {'measure': 'Long-term Self-Efficacy', 'timeFrame': '12 months', 'description': 'Level of self-efficacy as measured by "I feel like I\'m in control of my alcohol or drug use."'}, {'measure': 'Change in Mental Health', 'timeFrame': '3, 6, and 9 months', 'description': 'Level of mental health severity as measured by the Brief Symptom Inventory'}, {'measure': 'Long-term Mental Health', 'timeFrame': '12 months', 'description': 'Level of mental health severity as measured by the Brief Symptom Inventory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Residential substance use treatment', 'Transition'], 'conditions': ['Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.', 'detailedDescription': 'This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.\n\nExclusion Criteria:\n\n* Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:\n\n 1. Anyone under the age of 18\n 2. Non-English speaking individuals due to limited resources\n 3. Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.\n 4. Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02670902', 'briefTitle': 'Intervention for Persons Leaving Residential Substance Abuse Treatment', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx', 'orgStudyIdInfo': {'id': 'K01DA035330', 'link': 'https://reporter.nih.gov/quickSearch/K01DA035330', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Critical Time Intervention-Residential', 'description': 'CTI-R is a 9-month, assertive outreach and linkage program.', 'interventionNames': ['Behavioral: Critical Time Intervention-Residential (CTI-R)', 'Behavioral: Enhanced Usual Discharge Services-Residential']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Discharge-Residential', 'description': 'The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.', 'interventionNames': ['Behavioral: Enhanced Usual Discharge Services-Residential']}], 'interventions': [{'name': 'Critical Time Intervention-Residential (CTI-R)', 'type': 'BEHAVIORAL', 'description': 'CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program.', 'armGroupLabels': ['Critical Time Intervention-Residential']}, {'name': 'Enhanced Usual Discharge Services-Residential', 'type': 'BEHAVIORAL', 'description': 'The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.', 'armGroupLabels': ['Critical Time Intervention-Residential', 'Enhanced Usual Discharge-Residential']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jennifer I Manuel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}