Trial Outcomes & Findings for Organization-level Youth Engagement Approach for Substance Misuse Prevention (NCT NCT05736211)
NCT ID: NCT05736211
Last Updated: 2025-10-31
Results Overview
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.
COMPLETED
NA
43 participants
Month 6
2025-10-31
Participant Flow
Unit of analysis: Organization
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36 2
|
7 2
|
|
Overall Study
COMPLETED
|
30 2
|
7 2
|
|
Overall Study
NOT COMPLETED
|
6 0
|
0 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
Baseline Characteristics
Organization-level Youth Engagement Approach for Substance Misuse Prevention
Baseline characteristics by cohort
| Measure |
Intervention
n=36 Participants
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
|
Control
n=7 Participants
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age categories · 18 to 29 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 30 to 39 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 40 to 49 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 50 to 59 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 60 years or older
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 11 to 17 years
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex: Female, Male · Female
|
28 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex: Female, Male · Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex: Female, Male · Missing data
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: The population for this outcome is the YE intervention organizations only (intervention arm only).
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.
Outcome measures
| Measure |
Intervention
n=4 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Staff Surveys--Youth Engagement (YE) Prevention Programming Value
|
4 score on a scale
Standard Deviation .816
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only).
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.
Outcome measures
| Measure |
Intervention
n=4 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Perceived Retention of Youth/Young Adults in Youth Engagement (YE) Prevention Programming
|
4.5 score on a scale
Standard Deviation .577
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: The population for this outcome is the organization leaders and staff in the YE intervention organizations only (intervention arm only).
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.
Outcome measures
| Measure |
Intervention
n=4 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Perceived Usefulness of Youth Engagement (YE) Prevention
Usefulness of YE intervention to community
|
3.75 score on a scale
Standard Deviation .957
|
—
|
|
Perceived Usefulness of Youth Engagement (YE) Prevention
Usefulness of YE intervention to youth/young adults
|
4 score on a scale
Standard Deviation .816
|
—
|
|
Perceived Usefulness of Youth Engagement (YE) Prevention
Usefulness of YE intervention to organization
|
4 score on a scale
Standard Deviation .816
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: The population for this outcome is organization leaders and staff in both YE intervention and control organizations (intervention and control arms only).
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.
Outcome measures
| Measure |
Intervention
n=4 Participants
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
|
Control
n=7 Participants
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches
Effectiveness of general prevention approaches
|
3.50 score on a scale
Standard Deviation .577
|
3.71 score on a scale
Standard Deviation .951
|
|
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches
Quality of general prevention approaches
|
3.75 score on a scale
Standard Deviation .50
|
3.86 score on a scale
Standard Deviation 1.07
|
|
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches
Reach of general prevention approaches
|
3.75 score on a scale
Standard Deviation .957
|
3.71 score on a scale
Standard Deviation 1.1
|
|
Perceived Effectiveness, Quality, Reach, and Usefulness of General Prevention Approaches
Usefulness of general prevention approaches
|
3.75 score on a scale
Standard Deviation .500
|
3.86 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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 .
Outcome measures
| Measure |
Intervention
n=26 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Leadership and Communication Skills
Youth Pre survey
|
3.8 score on a scale
Standard Deviation .64
|
—
|
|
Youth/Young Adults: Leadership and Communication Skills
Youth Post survey
|
4.0 score on a scale
Standard Deviation .55
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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.
Outcome measures
| Measure |
Intervention
n=26 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Self-efficacy
Youth pre-survey
|
3.77 score on a scale
Standard Deviation .39
|
—
|
|
Youth/Young Adults: Self-efficacy
Youth post-survey
|
4.10 score on a scale
Standard Deviation .45
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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.
Outcome measures
| Measure |
Intervention
n=24 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Self Esteem
Youth pre-survey
|
3.30 score on a scale
Standard Deviation .58
|
—
|
|
Youth/Young Adults: Self Esteem
Youth post-survey
|
3.54 score on a scale
Standard Deviation .76
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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.
Outcome measures
| Measure |
Intervention
n=26 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Social Connectedness
Youth pre-survey
|
4.25 score on a scale
Standard Deviation .70
|
—
|
|
Youth/Young Adults: Social Connectedness
Youth post-survey
|
4.26 score on a scale
Standard Deviation .62
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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.
Outcome measures
| Measure |
Intervention
n=26 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Meaningful Social Role
Youth pre-survey
|
4.03 score on a scale
Standard Deviation .54
|
—
|
|
Youth/Young Adults: Meaningful Social Role
Youth post-survey
|
4.20 score on a scale
Standard Deviation .62
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The population for this outcome is the youth/young adult participants only (youth organizational participants arm).
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.
Outcome measures
| Measure |
Intervention
n=25 Participants
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
|
Control
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
|
|---|---|---|
|
Youth/Young Adults: Beliefs and Intentions Related to Substance Use
Youth pre-survey
|
2.74 score on a scale
Standard Deviation .32
|
—
|
|
Youth/Young Adults: Beliefs and Intentions Related to Substance Use
Youth post-survey
|
2.75 score on a scale
Standard Deviation .37
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Parissa Ballard
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place