Organization-level Youth Engagement Approach for Substance Misuse Prevention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05736211

Enrollment

Registered

2023-02-21

Start date

2024-03-14

Completion date

2025-07-01

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Opioid Use, Substance Misuse, Substance Use

Keywords

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

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.

Detailed description

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.

Interventions

BEHAVIORALOrganization-level Youth Engagement prevention strategy

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Staff Surveys--Youth Engagement (YE) Prevention Programming Value	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.
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	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.
Perceived Usefulness of Youth Engagement (YE) Prevention	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.
Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming	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.

Secondary

Measure	Time frame	Description
Youth/Young Adults: Self Esteem	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.
Youth/Young Adults: Leadership and Communication Skills	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 .
Youth/Young Adults: Self-efficacy	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.
Youth/Young Adults: Social Connectedness	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.
Youth/Young Adults: Meaningful Social Role	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.
Youth/Young Adults: Beliefs and Intentions Related to Substance Use	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

Measure	Time frame	Description
Exploratory--Retention of Youth/Young Adults in Youth Engagement Prevention Programming, Qualitative	Month 6	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Exploratory--Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches, Qualitative	Month 6	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Exploratory--Youth Engagement Prevention Programming Value, Qualitative	Month 6	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Exploratory--Perceived Usefulness of Youth Engagement Prevention, Qualitative	Month 6	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Exploratory--Reach of Youth Engagement Prevention Efforts in the Community, Qualitative	Month 6	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

Countries

United States

Participant flow

Participants by arm

Arm	Count
Intervention 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. Organization-level Youth Engagement prevention strategy: Systematically incorporating Youth Engagement into prevention efforts in a community setting	36
Control This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component	7
Total	43

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	6	0

Baseline characteristics

Characteristic	Total	Control	Intervention
Age, Customized Age categories 11 to 17 years	30 Participants	0 Participants	30 Participants
Age, Customized Age categories 18 to 29 years	4 Participants	2 Participants	2 Participants
Age, Customized Age categories 30 to 39 years	4 Participants	1 Participants	3 Participants
Age, Customized Age categories 40 to 49 years	2 Participants	1 Participants	1 Participants
Age, Customized Age categories 50 to 59 years	1 Participants	1 Participants	0 Participants
Age, Customized Age categories 60 years or older	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	12 Participants	0 Participants	12 Participants
Race (NIH/OMB) Black or African American	7 Participants	0 Participants	7 Participants
Race (NIH/OMB) More than one race	7 Participants	2 Participants	5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	0 Participants	3 Participants
Race (NIH/OMB) White	14 Participants	5 Participants	9 Participants
Sex/Gender, Customized Sex: Female, Male Female	33 Participants	5 Participants	28 Participants
Sex/Gender, Customized Sex: Female, Male Male	9 Participants	2 Participants	7 Participants
Sex/Gender, Customized Sex: Female, Male Missing data	1 Participants	0 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 36	0 / 7
other Total, other adverse events	0 / 36	0 / 7
serious Total, serious adverse events	0 / 36	0 / 7

Outcome results

Primary

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.

Time frame: Month 6

Population: The population for this outcome is organization leaders and staff in both YE intervention and control organizations (intervention and control arms only).

Arm	Measure	Group	Value (MEAN)	Dispersion
Intervention	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Effectiveness of general prevention approaches	3.50 score on a scale	Standard Deviation 0.577
Intervention	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Quality of general prevention approaches	3.75 score on a scale	Standard Deviation 0.5
Intervention	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Reach of general prevention approaches	3.75 score on a scale	Standard Deviation 0.957
Intervention	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Usefulness of general prevention approaches	3.75 score on a scale	Standard Deviation 0.5
Control	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Usefulness of general prevention approaches	3.86 score on a scale	Standard Deviation 1.22
Control	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Effectiveness of general prevention approaches	3.71 score on a scale	Standard Deviation 0.951
Control	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Reach of general prevention approaches	3.71 score on a scale	Standard Deviation 1.1
Control	Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches	Quality of general prevention approaches	3.86 score on a scale	Standard Deviation 1.07

Primary

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.

Time frame: Month 6

Population: The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only).

Arm	Measure	Value (MEAN)	Dispersion
Intervention	Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming	4.5 score on a scale	Standard Deviation 0.577

Primary

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.

Time frame: Month 6

Population: The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only).

Arm	Measure	Group	Value (MEAN)	Dispersion
Intervention	Perceived Usefulness of Youth Engagement (YE) Prevention	Usefulness of YE intervention to youth/young adults	4 score on a scale	Standard Deviation 0.816
Intervention	Perceived Usefulness of Youth Engagement (YE) Prevention	Usefulness of YE intervention to organization	4 score on a scale	Standard Deviation 0.816
Intervention	Perceived Usefulness of Youth Engagement (YE) Prevention	Usefulness of YE intervention to community	3.75 score on a scale	Standard Deviation 0.957

Primary

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.

Time frame: Month 6

Population: The population for this outcome is the YE intervention organizations only (intervention arm only).

Arm	Measure	Value (MEAN)	Dispersion
Intervention	Staff Surveys--Youth Engagement (YE) Prevention Programming Value	4 score on a scale	Standard Deviation 0.816

Secondary

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

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.