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Completed

NCT Number: NCT05736211

Organization-level Youth Engagement Approach for Substance Misuse Prevention

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.

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Key information

Conditions

Drug Use Chemically-Induced Disorders Mental Disorders Opioid Use Substance Misuse Substance Use Substance-Related Disorders

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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 youth and young adults 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 youth and young adults often do not effectively involve them. Engaging youth and young adults 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 youth and young adults 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 young adults. This project tests an organization-level Youth Engagement (YE) approach to improve prevention.

Only organizations randomized to treatment will include youth/Young Adult (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organization-level Youth Engagement prevention strategy

Behavioral

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Primary outcomes

  1. Staff Surveys--Youth Engagement (YE) Prevention Programming Value

    Time frame: Month 6

    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.

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

    Time frame: Month 6

    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.

  3. Perceived Usefulness of Youth Engagement (YE) Prevention

    Time frame: Month 6

    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.

  4. Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches

    Time frame: Month 6

    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.

Secondary outcomes

  1. Youth/Young Adults: Leadership and Communication Skills

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (YE) intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating greater leadership and communication skills .

  2. Youth/Young Adults: Self-efficacy

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (YE) intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating higher self-efficacy.

  3. Youth/Young Adults: Self Esteem

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (YE) intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating greater self esteem.

  4. Youth/Young Adults: Social Connectedness

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey administered to young adults involved in the youth engagement YE intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating greater social connectedness.

  5. Youth/Young Adults: Meaningful Social Role

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (YE) intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating higher perceived meaningful social role.

  6. Youth/Young Adults: Beliefs and Intentions Related to Substance Use

    Time frame: Baseline and Month 6

    This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (YE) intervention at baseline (pre-YE) and 6 months later (post-YE). The survey measures will be on a 1-5 scale with higher scores indicating safer beliefs about perceived risks.

Other outcomes

  1. Exploratory--Youth Engagement Prevention Programming Value, Qualitative

    Time frame: Month 6

    This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

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

    Time frame: Month 6

    This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

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

    Time frame: Month 6

    This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

  4. Exploratory--Perceived Usefulness of Youth Engagement Prevention, Qualitative

    Time frame: Month 6

    This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

  5. Exploratory--Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches, Qualitative

    Time frame: Month 6

    This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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