Organization-level Youth Engagement Approach for Substance Misuse Prevention

• ClinicalTrials.gov Identifier: NCT05736211
• Recruitment Status: Recruiting
• First Posted: February 21, 2023
• Last Update Posted: March 25, 2024
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: February 9, 2023
• First Posted Date: February 21, 2023
• Last Update Posted Date: March 25, 2024
• Actual Study Start Date: March 14, 2024
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2023)

• Staff Surveys--YE Prevention Programming Value [ Time Frame: 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. Results will be reported as mean/SD.
• Retention Percentage of Youth/Young Adults in YE Prevention Programming [ Time Frame: Month 6 ]
  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.
• Perceived Usefulness of YE prevention [ Time Frame: 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. Results will be reported as mean/SD.
• Perceived effectiveness, quality, reach, and usefulness of general prevention approaches [ Time Frame: Month 6 ]
  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.

Original Primary Outcome Measures (submitted: February 9, 2023)

• Staff Surveys--YE Prevention Programming Value [ Time Frame: 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. Results will be reported as mean/SD.
• Retention Percentage of Youth/Young Adults in YE Prevention Programming [ Time Frame: Month 6 ]
  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.
• Reach of YE Prevention Efforts in the Community [ Time Frame: 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 higher scores indicating a higher perceived reach of the community prevention efforts. Results will be reported as mean/SD.
• Perceived Usefulness of YE prevention [ Time Frame: 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. Results will be reported as mean/SD.
• Perceived effectiveness, quality, reach, and usefulness of general prevention approaches [ Time Frame: 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 higher scores indicating higher perceived quality, reach, and usefulness. Results will be reported as mean/SD.

Current Secondary Outcome Measures (submitted: February 9, 2023)

• Youth/young adults: leadership and communication skills [ Time Frame: Baseline and Month 6 ]
  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.
• Youth/young adults: self-efficacy [ Time Frame: Baseline and Month 6 ]
  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.
• Youth/young adults: self esteem [ Time Frame: Baseline and Month 6 ]
  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.
• Youth/young adults: social connectedness [ Time Frame: Baseline and Month 6 ]
  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.
• Youth/young adults: meaningful social role [ Time Frame: Baseline and Month 6 ]
  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.
• Youth/young adults: beliefs and intentions related to substance use [ Time Frame: Baseline and Month 6 ]
  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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 9, 2023)

• Exploratory--YE Prevention Programming Value, Qualitative [ Time Frame: Month 6 ]
  This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
• Exploratory--Retention of Youth/Young Adults in YE Prevention Programming, Qualitative [ Time Frame: Month 6 ]
  This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
• Exploratory--Reach of YE Prevention Efforts in the Community, Qualitative [ Time Frame: Month 6 ]
  This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
• Exploratory--Perceived Usefulness of YE prevention, Qualitative [ Time Frame: 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 [ Time Frame: Month 6 ]
  This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Organization-level Youth Engagement Approach for Substance Misuse Prevention
• Official Title: Organization-level Youth Engagement Approach for Substance Misuse 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 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Drug Use
• Substance Use
• Opioid Use
• Substance Misuse

Intervention

Behavioral: Organization-level Youth Engagement prevention strategy

Systematically incorporating Youth Engagement into prevention efforts in a community setting

Study Arms

• 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.
  Intervention: Behavioral: Organization-level Youth Engagement prevention strategy
• 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

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).

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 9, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2025
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Parissa J Ballard, PhD; 336-716-0793; pballard@wakehealth.edu

Contact: Taylor Arnold; 336-713-5019; tjarnold@wakehealth.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05736211
• Other Study ID Numbers: IRB00091590; 5K01DA048201-03 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Current Responsible Party: Wake Forest University Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Wake Forest University Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Parissa J Ballard, PhD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: January 2024