Organization-level Youth Engagement Approach for Substance Misuse Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use; Opioid Use; Drug Use; Substance Misuse
• Intervention / Treatment: Behavioral: Organization-level Youth Engagement prevention strategy

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Parissa J Ballard, PhD; Phone Number: 336-716-0793; Email: pballard@wakehealth.edu
• Study Contact Backup: Name: Taylor Arnold; Phone Number: 336-713-5019; Email: tjarnold@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest School of Medicine
      • Contact: Parissa J Ballard, PhD; Phone Number: 336-716-0793; Email: pballard@wakehealth.edu
      • Contact: Taylor Arnold; Phone Number: 336-713-5019; Email: tjarnold@wakehealth.edu
      • Principal Investigator: Parissa Ballard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2 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.	Behavioral: Organization-level Youth Engagement prevention strategy; Systematically incorporating Youth Engagement into prevention efforts in a community setting
No Intervention: Phase 2 control; This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory--YE Prevention Programming Value, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
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
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
Exploratory--Perceived Usefulness of YE prevention, Qualitative	This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff	Month 6
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Parissa J Ballard, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Erikson, E. H. Identity: Youth and crisis. (WW Norton & Company, 1968).
• 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.
• 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.
• Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 47, 53-68 (1991).

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Prevention; Young adults; Randomized control trial; Youth Engagement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB00091590; 5K01DA048201-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available. The information collected about organizations and from individual participants will be kept confidential; only aggregate results will be reported in manuscripts and reports.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No