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NCT05736211
Organization-level Youth Engagement Approach for Substance Misuse Prevention
Conditions: Drug Use, Substance Use, Opioid Use, Substance Misuse
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Wake Forest University Health Sciences
Location: United States
Summary
Phase 1 will consist of a small pilot Open Trial (OT).
The objective of Phase 1 is to develop an organization-level YE prevention strategy and implement it in a community-based organization to test feasibility and acceptability in an open trial with one organization.
This will include developing a manual for systematically incorporating YE into prevention efforts in community settings.
Phase 2 will consist of a small pilot Randomized Controlled Trial (RCT).
Four prevention organizations will be randomized either to include Youth Engagement in prevention efforts (treatment) or not (control).
The study team will attempt to match the treatment and control groups on relevant characteristics such as geographic location (e.g., urban, rural), population served (e.g., church-based, school-based), and/or prior Youth Engagement involvement.
The objective of the second phase of this study is to evaluate the preliminary effectiveness of Youth Engagement (YE) as a prevention strategy for opioid misuse in a small pilot randomized control trial (RCT).
This pilot study will examine the effects of the YE prevention strategy on (a) organization-level outcomes, such as perceived value added to prevention programming and (b) individual-level outcomes such as personal skills and attitudes as well as knowledge and attitudes about substances including opioids.
Up to 15 leaders/staff and 45 youth/young adults (60 people overall) will be recruited for the study.
Eligibility Criteria
INCLUSION CRITERIA:Organizational leaders/staff:Leaders or staff of community-based prevention organizations based in North CarolinaOrganizations are youth/young adult-serving and focused on opioid misuse preventionOrganizations demonstrate readiness, interest, need, and resources to invest in Youth Engagement as part of preventionLeaders or staff are or would be involved in implementing Youth Engagement strategy at the organizationLeaders or staff are able to speak and read English fluentlyYouth/young adult participants involved with organizations:Adolescents and young adults age 16 - 29Engaged as volunteers with the organization's opioid misuse prevention effortsAble to speak and read English fluentlyEXCLUSION CRITERIA:• Organizations already incorporating a high level of Youth Engagement in its prevention work
Source: ClinicalTrials.gov (NCT05736211). StuddyBuddy aggregates publicly available trial information.