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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Month 6

Results posted on

2025-10-31

Participant Flow

Unit of analysis: Organization

Participant milestones

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

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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

This 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 6

This 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 6

This 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 6

This 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 6

This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 704-355-2000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place