- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05374395
Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults (P2P)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
At 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
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Farmington, Connecticut, United States, 06030
- UConn Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-25
- initiating outpatient treatment for a substance use problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Services
clinics will continue to deliver their normal outpatient services
|
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Experimental: Peer Recovery Support - Delivered Dropout Prevention + Usual Services
clinics will continue to deliver their normal outpatient services plus the peer recovery support-delivered dropout prevention enhancement
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who dropout from substance use services
Time Frame: 90 days from initiation of treatment
|
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.
|
90 days from initiation of treatment
|
Number of missed sessions and no show sessions
Time Frame: 90 days from initiation of treatment
|
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.
|
90 days from initiation of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristyn Zajac, PhD, UConn Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-097-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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