Organization-level Youth Engagement Approach for Substance Misuse Prevention

Opioid Use Clinical Trial

Official title:

Organization-level Youth Engagement Approach for Substance Misuse Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736211
• Other study ID #: IRB00091590
• Secondary ID: 5K01DA048201-03
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Parissa J Ballard, PhD
• Phone: 336-716-0793
• Email: pballard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1 will consist of a small pilot Open Trial (OT). The objective of Phase 1 is to develop an organization-level 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 Youth Engagement (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.

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 young adults (YAs) 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 YAs often do not effectively involve them. Engaging YAs 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 YAs 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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 16 - 29

• Engaged as volunteers with the organization's opioid misuse prevention efforts

• Able to speak and read English fluently

EXCLUSION CRITERIA:

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

Related Conditions & MeSH terms

• Drug Use
• Opioid Use
• Substance Misuse
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Organization-level Youth Engagement prevention strategy
Systematically incorporating Youth Engagement into prevention efforts in a community setting

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory--YE Prevention Programming Value, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
Other	Exploratory--Retention of Youth/Young Adults in YE Prevention Programming, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
Other	Exploratory--Reach of YE Prevention Efforts in the Community, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
Other	Exploratory--Perceived Usefulness of YE prevention, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
Other	Exploratory--Perceived effectiveness, quality, reach, and usefulness of general prevention approaches, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
Primary	Staff Surveys--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. Results will be reported as mean/SD.	Month 6
Primary	Retention Percentage of Youth/Young Adults in YE Prevention Programming	This outcome will be assessed through a survey measure administered to the organization leaders and staff in the YE intervention organizations only. It will be reported as count/percent.	Month 6
Primary	Perceived Usefulness of 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. Results will be reported as mean/SD.	Month 6
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 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. Results will be reported as mean/SD.	Month 6
Secondary	Youth/young adults: leadership and communication skills	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and results reported as change in means from pre to post intervention.	Baseline and Month 6
Secondary	Youth/young adults: self-efficacy	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and results reported as change in means from pre to post intervention.	Baseline and Month 6
Secondary	Youth/young adults: self esteem	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and results reported as change in means from pre to post intervention.	Baseline and Month 6
Secondary	Youth/young adults: social connectedness	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and results reported as change in means from pre to post intervention.	Baseline and Month 6
Secondary	Youth/young adults: meaningful social role	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and results reported as change in means from pre to post intervention.	Baseline and Month 6
Secondary	Youth/young adults: beliefs and intentions related to substance use	This outcome will be assessed through a survey measure administered to YAs involved in the 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 and intentions and results reported as change in means from pre to post intervention.	Baseline and Month 6