Organization-level Youth Engagement Approach for Substance Misuse Prevention
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ClinicalTrials.gov Identifier: NCT05736211 |
Recruitment Status :
Recruiting
First Posted : February 21, 2023
Last Update Posted : March 25, 2024
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Condition or disease | Intervention/treatment | Phase |
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Drug Use Substance Use Opioid Use Substance Misuse | Behavioral: Organization-level Youth Engagement prevention strategy | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Organization-level Youth Engagement Approach for Substance Misuse Prevention |
Actual Study Start Date : | March 14, 2024 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | October 2025 |
Arm | Intervention/treatment |
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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.
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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
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- 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.
- 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.
- 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
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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05736211
Contact: Parissa J Ballard, PhD | 336-716-0793 | pballard@wakehealth.edu | |
Contact: Taylor Arnold | 336-713-5019 | tjarnold@wakehealth.edu |
United States, North Carolina | |
Wake Forest School of Medicine | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Parissa J Ballard, PhD 336-716-0793 pballard@wakehealth.edu | |
Contact: Taylor Arnold 336-713-5019 tjarnold@wakehealth.edu | |
Principal Investigator: Parissa Ballard, PhD |
Principal Investigator: | Parissa J Ballard, PhD | Wake Forest University Health Sciences |
Other Publications:
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT05736211 |
Other Study ID Numbers: |
IRB00091590 5K01DA048201-03 ( U.S. NIH Grant/Contract ) |
First Posted: | February 21, 2023 Key Record Dates |
Last Update Posted: | March 25, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adolescents Young adults Prevention Youth Engagement Randomized control trial |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |