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N/A N=43 Randomized Prevention

Organization-level Youth Engagement Approach for Substance Misuse Prevention

Drug Use · Substance Use · Opioid Use · Substance Misuse

Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Staff Surveys--Youth Engagement (YE) Prevention Programming Value — 4 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Organization-level Youth Engagement prevention strategy (Behavioral)
Age
Pediatric, Adult, Older Adult · 11+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Jul 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Staff Surveys--Youth Engagement (YE) Prevention Programming Value
4
PRIMARY
Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming
4.5
PRIMARY
Perceived Usefulness of Youth Engagement (YE) Prevention
4; 4; 3.75
PRIMARY
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches
3.50; 3.71; 3.75; 3.86; 3.75; 3.71
SECONDARY
Youth/Young Adults: Leadership and Communication Skills
3.8; 4.0
SECONDARY
Youth/Young Adults: Self-efficacy
3.77; 4.10
SECONDARY
Youth/Young Adults: Self Esteem
3.30; 3.54
SECONDARY
Youth/Young Adults: Social Connectedness
4.25; 4.26
SECONDARY
Youth/Young Adults: Meaningful Social Role
4.03; 4.20
SECONDARY
Youth/Young Adults: Beliefs and Intentions Related to Substance Use
2.74; 2.75

Summary

This study 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 this study is to evaluate the preliminary effectiveness of 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 Carolina
  • Organizations are youth/young adult-serving and focused on opioid misuse prevention
  • Organizations demonstrate readiness, interest, need, and resources to invest in Youth Engagement as part of prevention
  • Leaders or staff are or would be involved in implementing Youth Engagement strategy at the organization
  • Leaders or staff are able to speak and read English fluently

Youth/young adult participants involved with organizations:

  • Adolescents and young adults age 11 - 29
  • Interested in participating in Youth Engagement with the community organization
  • Able to speak and read English fluently

EXCLUSION CRITERIA

  • Organizations already incorporating a high level of Youth Engagement in its prevention work
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05736211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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