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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01DA048201-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study 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 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.
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 young adults. This project tests an organization-level Youth Engagement (YE) approach to improve prevention.
Only organizations randomized to treatment will include youth/Young Adult (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. Youth (individuals) participating in the intervention organizations' programming following the organization's completion of the YE intervention will complete surveys. |
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| Control group | No Intervention | This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organization-level Youth Engagement prevention strategy | Behavioral | Systematically incorporating Youth Engagement into prevention efforts in a community setting |
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| Measure | Description | Time Frame |
|---|---|---|
| Staff Surveys--Youth Engagement (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. | Month 6 |
| Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming | This outcome will be assessed through a survey measure on a 1-5 scale administered to the organization leaders and staff in the YE intervention organizations only, with higher scores indicated better retention. | Month 6 |
| Perceived Usefulness of Youth Engagement (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. | 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 Youth Engagement (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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Youth/Young Adults: Leadership and Communication Skills | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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 . | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory--Youth Engagement 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 Youth Engagement Prevention Programming, Qualitative |
INCLUSION CRITERIA:
Organizational leaders/staff:
Youth/young adult participants involved with organizations:
EXCLUSION CRITERIA:
• Organizations already incorporating a high level of Youth Engagement in its prevention work
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| Name | Affiliation | Role |
|---|---|---|
| Parissa J Ballard, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Erikson, E. H. Identity: Youth and crisis. (WW Norton & Company, 1968). | ||
| 8442578 | Background | 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. | |
| 2042607 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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 with 2 youth prevention organizations randomized to this arm. Participants will include organizational leaders/staff. Upon completion of the organization intervention. Youth (individuals) participating in the intervention organizations' programming will complete surveys. |
| FG001 | Control Group | This arm will receive no intervention. Organizations randomized to the control group will continue their normal prevention strategy without the inclusion of a Youth Engagement component. Participants will include organizational leaders/staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Organization-level Youth Engagement prevention strategy: Systematically incorporating Youth Engagement into prevention efforts in a community setting |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Staff Surveys--Youth Engagement (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. | The population for this outcome is the YE intervention organizations only (intervention arm only). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
Baseline through month 6
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Organization-level Youth Engagement prevention strategy: Systematically incorporating Youth Engagement into prevention efforts in a community setting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Parissa Ballard | Wake Forest University School of Medicine | 704-355-2000 | parissa.ballard@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2024 | Sep 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2025 | Aug 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Youth/Young Adults: Self-efficacy | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | Baseline and Month 6 |
| Youth/Young Adults: Self Esteem | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | Baseline and Month 6 |
| Youth/Young Adults: Social Connectedness | This outcome will be assessed through a survey administered to young adults involved in the youth engagement 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. | Baseline and Month 6 |
| Youth/Young Adults: Meaningful Social Role | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | 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 young adults involved in the youth engagement (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 about perceived risks. | Baseline and Month 6 |
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff |
| Month 6 |
| Exploratory--Reach of Youth Engagement 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 Youth Engagement 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 |
| Background |
| 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. |
| Result | Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 47, 53-68 (1991). |
| BG001 |
| Control |
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming | This outcome will be assessed through a survey measure on a 1-5 scale administered to the organization leaders and staff in the YE intervention organizations only, with higher scores indicated better retention. | The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Primary | Perceived Usefulness of Youth Engagement (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. | The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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 Youth Engagement (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. | The population for this outcome is organization leaders and staff in both YE intervention and control organizations (intervention and control arms only). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Youth/Young Adults: Leadership and Communication Skills | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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 . | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Secondary | Youth/Young Adults: Self-efficacy | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Secondary | Youth/Young Adults: Self Esteem | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Secondary | Youth/Young Adults: Social Connectedness | This outcome will be assessed through a survey administered to young adults involved in the youth engagement 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. | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Secondary | Youth/Young Adults: Meaningful Social Role | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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. | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Secondary | Youth/Young Adults: Beliefs and Intentions Related to Substance Use | This outcome will be assessed through a survey measure administered to young adults involved in the youth engagement (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 about perceived risks. | The population for this outcome is the youth/young adult participants only (youth organizational participants arm). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Month 6 |
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| Other Pre-specified | Exploratory--Youth Engagement Prevention Programming Value, Qualitative | This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff | Not Posted | Month 6 | Participants |
| Other Pre-specified | Exploratory--Retention of Youth/Young Adults in Youth Engagement Prevention Programming, Qualitative | This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff | Not Posted | Month 6 | Participants |
| Other Pre-specified | Exploratory--Reach of Youth Engagement Prevention Efforts in the Community, Qualitative | This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff | Not Posted | Month 6 | Participants |
| Other Pre-specified | Exploratory--Perceived Usefulness of Youth Engagement Prevention, Qualitative | This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff | Not Posted | Month 6 | Participants |
| Other Pre-specified | 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 | Not Posted | Month 6 | Participants |
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Control | This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component | 0 | 7 | 0 | 7 | 0 | 7 |
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| Reach of general prevention approaches |
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| Usefulness of general prevention approaches |
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