Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 9:02 PM
Study NCT ID:
NCT05374395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2022-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Primary outcomes will come from the clinics' chart data. Individuals pulling data from charts will be blind to study condition."}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A stepped-wedge cluster randomized design will include five blocks of two clinics randomized to the timing of the Peer recovery support-delivered Dropout Prevention enhancement, with each clinic having two phases: a longitudinal Usual Services (US) Phase and a longitudinal Usual Services + Peer recovery support-delivered Dropout Prevention (PDP) enhancement Phase. All clusters will have a baseline phase and will be randomized to the timing of the PDP phase. Once randomized to begin, all clusters will have a 24-month US+PDP Phase.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who dropout from substance use services', 'timeFrame': '90 days from initiation of treatment', 'description': 'Data will come from de-identified clinical charts. Dropout will be defined in two ways: 1) patient did not complete the total number of sessions prescribed in the treatment plan and 2) patient was in treatment for less than 90 days.'}, {'measure': 'Number of missed sessions and no show sessions', 'timeFrame': '90 days from initiation of treatment', 'description': 'Data will come from de-identified clinical charts. Number of missed sessions or no shows will be evaluated based on the number of scheduled sessions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peer recovery supports', 'emerging adults', 'recovery support services'], 'conditions': ['Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'Emerging adults (ages 18-25) are at higher risk for substance use disorders, including opiate addiction, than any other age group but are also more likely to drop out early from substance use treatment services. This project will evaluate an enhancement to usual services, delivered by peer recovery supports, specifically aimed at improving treatment adherence and reducing dropout in this age group. The study will also answer key questions about risk factors for dropout among emerging adults and the financial sustainability of enhancing services to reduce dropout.', 'detailedDescription': 'Emerging adults (EAs; ages 18-25) have higher rates of substance use disorders than any other age group and have been hit particularly hard by the opioid crisis. EAs also demonstrate poor adherence to healthcare regimens associated with substance use services, with higher dropout rates and lower service utilization than any other age group. This poor adherence leads to devastating outcomes, including continued substance use, incarceration, and overdose. In addition, high dropout rates contribute to skyrocketing costs to treatment systems as a result of more acute service needs, expensive service utilization, and long waitlists. Cost-effective strategies that are aimed at improving treatment adherence to substance use services and tailored to meet the unique developmental needs of EAs are an imminent need. Further, little is known about risk factors for dropout specific to this age group, hindering effective system responses to this significant problem.\n\nAt the same time, substance use service systems are increasingly using peer recovery supports (PRS; i.e., paraprofessionals who have "lived experience" with substance use problems) to bolster treatment outcomes without incurring considerable additional costs. However, services delivered by PRS have not been tailored specifically to reduce EA dropout, and few have been rigorously tested at all. The current study will evaluate an innovative EA-specific dropout prevention enhancement to usual treatment services, delivered by PRS in community-based substance use treatment clinics (Aim 1). The investigators will employ a stepped-wedge cluster randomized design, resulting in each clinic having a longitudinal usual services phase and a longitudinal dropout prevention phase. The two phases will be compared on rates of EA dropout and service utilization using objective data from clinical charts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-25\n* initiating outpatient treatment for a substance use problem'}, 'identificationModule': {'nctId': 'NCT05374395', 'acronym': 'P2P', 'briefTitle': 'Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults', 'orgStudyIdInfo': {'id': '21-097-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Services', 'description': 'clinics will continue to deliver their normal outpatient services'}, {'type': 'EXPERIMENTAL', 'label': 'Peer Recovery Support - Delivered Dropout Prevention + Usual Services', 'description': 'clinics will continue to deliver their normal outpatient services plus the peer recovery support-delivered dropout prevention enhancement', 'interventionNames': ['Behavioral: Peer Recovery Support-Delivered Dropout Prevention enhancement']}], 'interventions': [{'name': 'Peer Recovery Support-Delivered Dropout Prevention enhancement', 'type': 'BEHAVIORAL', 'description': 'Peer recovery supports will meet with emerging adults for four weekly sessions plus monthly check-ins during the next two months. Peer recovery supports will engage the emerging adults in motivational and skills-based strategies aimed at increasing adherence to services and attendance to treatment sessions.', 'armGroupLabels': ['Peer Recovery Support - Delivered Dropout Prevention + Usual Services']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Kristyn Zajac, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Social Learning Center', 'class': 'OTHER'}, {'name': 'University of Texas at Austin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kristyn Zajac', 'investigatorAffiliation': 'UConn Health'}}}}