Organization-level Youth Engagement Approach for Substance Misuse Prevention

Opioid Use Clinical Trial

Official title: Organization-level Youth Engagement Approach for Substance Misuse Prevention

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Background, Rationale and Context Substance misuse is a major public health problem and opioid misuse is an acute problem in rural and high poverty communities. Adolescence and young adulthood is a formative time for positive social development, as young people increase their needs for maturity and autonomy, define their identities, and carve out their roles in society. But many young adults (YAs) are isolated within communities, feel that they do not matter, and lack meaningful opportunities to engage with society and form positive connections with prosocial institutions. Further, community systems and settings that serve YAs often do not effectively involve them. Engaging YAs in their communities and in the prevention systems targeting substance misuse may prevent the use of substances by targeting two pathways. The first is an individual pathway via bolstering psychosocial development and reducing risks for opioids by providing YAs with meaningful prosocial opportunities to fulfill developmental needs. The second is an environmental pathway via affecting health system and community-based settings through improving prevention efforts targeting YAs. This project tests an organization-level Youth Engagement (YE) approach to improve prevention.

Only organizations randomized to treatment will include youth/YA participants. Youth/YA survey data will be collected at the start of their participation in the YE strategy (pre-YE) and 6 months later (post-YE). At the post-YE the study team will interview a subset of interested YE group participants to qualitatively assess their experiences and to identify, in their own voices, what aspects of YE emerge as important to youth development and their health-related decision-making.

The timeframe for this phase will be 12-18 months. ;

Related Conditions & MeSH terms

• Drug Use
• Opioid Use
• Substance Misuse
• Substance Use
• Substance-Related Disorders

• NCT number: NCT05736211
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Parissa J Ballard, PhD
• Phone: 336-716-0793
• Email: pballard@wakehealth.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Completion date: March 31, 2025