Clinical trial NCT05736211: Organization-level Youth Engagement Approach for Substance Misuse Prevention
Official title: Organization-level Youth Engagement Approach for Substance Misuse Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Use
Substance Use
Opioid Use
Substance Misuse
Keywords: Adolescents
Young adults
Prevention
Youth Engagement
Randomized control trial
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase 1 will consist of a small pilot Open Trial (OT). The objective of Phase 1 is to develop an organization-level Youth Engagement (YE) prevention strategy and implement it in a community-based organization to test feasibility and acceptability in an open trial with one organization. This will include developing a manual for systematically incorporating YE into prevention efforts in community settings. Phase 2 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 the second phase 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: Background, Rationale and Context 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 YAs. This project tests an organization-level Youth Engagement (YE) approach to improve prevention.

Only organizations randomized to treatment will include youth/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.

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 YE 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

Primary outcomes:
measure: Staff Surveys--YE Prevention Programming Value
timeFrame: Month 6
measure: Retention Percentage of Youth/Young Adults in YE Prevention Programming
timeFrame: Month 6
measure: Perceived Usefulness of YE prevention
timeFrame: Month 6
measure: Perceived effectiveness, quality, reach, and usefulness of general prevention approaches
timeFrame: Month 6
Secondary outcomes:
measure: Youth/young adults: leadership and communication skills
timeFrame: Baseline and Month 6
measure: Youth/young adults: self-efficacy
timeFrame: Baseline and Month 6
measure: Youth/young adults: self esteem
timeFrame: Baseline and Month 6
measure: Youth/young adults: social connectedness
timeFrame: Baseline and Month 6
measure: Youth/young adults: meaningful social role
timeFrame: Baseline and Month 6
measure: Youth/young adults: beliefs and intentions related to substance use
timeFrame: Baseline and Month 6
Other outcomes:
measure: Exploratory--YE Prevention Programming Value, Qualitative
timeFrame: Month 6
measure: Exploratory--Retention of Youth/Young Adults in YE Prevention Programming, Qualitative
timeFrame: Month 6
measure: Exploratory--Reach of YE Prevention Efforts in the Community, Qualitative
timeFrame: Month 6
measure: Exploratory--Perceived Usefulness of YE prevention, Qualitative
timeFrame: Month 6
measure: Exploratory--Perceived effectiveness, quality, reach, and usefulness of general prevention approaches, Qualitative
timeFrame: Month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Parissa J Ballard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erikson, E. H. Identity: Youth and crisis. (WW Norton & Company, 1968).
citation: 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.
citation: 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.
citation: Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 47, 53-68 (1991).