Organization-level Youth Engagement Approach for Substance Misuse Prevention

NCT05736211 | Completed Results DMC

• 2 other identifiers: IRB000915905K01DA048201-03
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Use; Substance Use; Opioid Use; Substance Misuse

Keywords

Adolescents; Young adults; Prevention; Youth Engagement; Randomized control trial

Outcome Measures

Primary Outcomes (4)

• Staff Surveys--Youth Engagement (YE) Prevention Programming Value

  This outcome will be assessed through a survey measure administered to the organization leaders and staff in the YE intervention organizations only. The survey measures will be on a 1-5 scale with a higher score meaning a higher perceived programming value.

  Month 6

• Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming

  This outcome will be assessed through a survey measure on a 1-5 scale administered to the organization leaders and staff in the YE intervention organizations only, with higher scores indicated better retention.

  Month 6

• Perceived Usefulness of Youth Engagement (YE) Prevention

  This outcome will be assessed through a survey measure administered to the organization leaders and staff in the YE intervention organizations only. The survey items will ask about perceived usefulness of the YE intervention for youth/young adults, the organization, and the community. Items will be on a 1-5 scale with higher scores indicating higher perceived usefulness.

  Month 6

• Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches

  This outcome will be assessed through a survey measure administered to the organization leaders and staff in the Youth Engagement (YE) intervention organizations and comparison organizations. The survey measures will be on a 1-5 scale with higher scores indicating higher perceived quality, reach, and usefulness.

  Month 6

Secondary Outcomes (6)

• Youth/Young Adults: Leadership and Communication Skills

  Baseline and Month 6

• Youth/Young Adults: Self-efficacy

  Baseline and Month 6

• Youth/Young Adults: Self Esteem

  Baseline and Month 6

• Youth/Young Adults: Social Connectedness

  Baseline and Month 6

• Youth/Young Adults: Meaningful Social Role

  Baseline and Month 6

Other Outcomes (5)

• Exploratory--Youth Engagement Prevention Programming Value, Qualitative

  Month 6

• Exploratory--Retention of Youth/Young Adults in Youth Engagement Prevention Programming, Qualitative

  Month 6

• Exploratory--Reach of Youth Engagement Prevention Efforts in the Community, Qualitative

  Month 6

Study Arms (2)

Intervention group

EXPERIMENTAL

In this arm the study will implement an organization-level Youth Engagement prevention strategy by systematically incorporating Youth Engagement into prevention efforts in a community setting. Youth (individuals) participating in the intervention organizations' programming following the organization's completion of the YE intervention will complete surveys.

Behavioral: Organization-level Youth Engagement prevention strategy

Control group

NO INTERVENTION

This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component

Interventions

Organization-level Youth Engagement prevention strategy BEHAVIORAL

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Intervention group

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Organizations already incorporating a high level of Youth Engagement in its prevention work

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• Erikson, E. H. Identity: Youth and crisis. (WW Norton & Company, 1968).

  BACKGROUND

• Eccles JS, Midgley C, Wigfield A, Buchanan CM, Reuman D, Flanagan C, Iver DM. Development during adolescence. The impact of stage-environment fit on young adolescents' experiences in schools and in families. Am Psychol. 1993 Feb;48(2):90-101. doi: 10.1037//0003-066x.48.2.90.

  PMID: 8442578 BACKGROUND

• Farrow JA. Youth alienation as an emerging pediatric health care issue. Am J Dis Child. 1991 May;145(5):491-2. doi: 10.1001/archpedi.1991.02160050015002. No abstract available.

  PMID: 2042607 BACKGROUND

• Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 47, 53-68 (1991).

  RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Parissa Ballard
• Organization: Wake Forest University School of Medicine

parissa.ballard@advocatehealth.org

704-355-2000

Study Officials

• Parissa J Ballard, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: March 14, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)