Organization-level Youth Engagement Approach for Substance Misuse Prevention

NCT ID: NCT05736211

Last Updated: 2025-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Drug Use Substance Use Opioid Use Substance Misuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Organization-level Youth Engagement prevention strategy

Intervention Type BEHAVIORAL

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Organization-level Youth Engagement prevention strategy

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Parissa J Ballard, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 8442578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2042607 (View on PubMed)

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

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K01DA048201-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00091590

Identifier Type: -

Identifier Source: org_study_id

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