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Organization-level Youth Engagement Approach for Substance Misuse Prevention

Primary Purpose

Drug Use, Substance Use, Opioid Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organization-level Youth Engagement prevention strategy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Use focused on measuring Adolescents, Young adults, Prevention, Youth Engagement, Randomized control trial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phase 2 intervention

Phase 2 control

Arm Description

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.

This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component

Outcomes

Primary Outcome Measures

Staff Surveys--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. Results will be reported as mean/SD.
Retention Percentage of Youth/Young Adults in YE Prevention Programming
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
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
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.

Secondary Outcome Measures

Youth/young adults: leadership and communication skills
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
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
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
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
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
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.

Full Information

First Posted
February 9, 2023
Last Updated
October 19, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05736211
Brief Title
Organization-level Youth Engagement Approach for Substance Misuse Prevention
Official Title
Organization-level Youth Engagement Approach for Substance Misuse Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Substance Use, Opioid Use, Substance Misuse
Keywords
Adolescents, Young adults, Prevention, Youth Engagement, Randomized control trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 control
Arm Type
No Intervention
Arm Description
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
Intervention Type
Behavioral
Intervention Name(s)
Organization-level Youth Engagement prevention strategy
Intervention Description
Systematically incorporating Youth Engagement into prevention efforts in a community setting
Primary Outcome Measure Information:
Title
Staff Surveys--YE Prevention Programming Value
Description
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.
Time Frame
Month 6
Title
Retention Percentage of Youth/Young Adults in YE Prevention Programming
Description
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.
Time Frame
Month 6
Title
Perceived Usefulness of YE prevention
Description
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.
Time Frame
Month 6
Title
Perceived effectiveness, quality, reach, and usefulness of general prevention approaches
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Youth/young adults: leadership and communication skills
Description
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.
Time Frame
Baseline and Month 6
Title
Youth/young adults: self-efficacy
Description
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.
Time Frame
Baseline and Month 6
Title
Youth/young adults: self esteem
Description
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.
Time Frame
Baseline and Month 6
Title
Youth/young adults: social connectedness
Description
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.
Time Frame
Baseline and Month 6
Title
Youth/young adults: meaningful social role
Description
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.
Time Frame
Baseline and Month 6
Title
Youth/young adults: beliefs and intentions related to substance use
Description
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.
Time Frame
Baseline and Month 6
Other Pre-specified Outcome Measures:
Title
Exploratory--YE Prevention Programming Value, Qualitative
Description
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Time Frame
Month 6
Title
Exploratory--Retention of Youth/Young Adults in YE Prevention Programming, Qualitative
Description
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Time Frame
Month 6
Title
Exploratory--Reach of YE Prevention Efforts in the Community, Qualitative
Description
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Time Frame
Month 6
Title
Exploratory--Perceived Usefulness of YE prevention, Qualitative
Description
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Time Frame
Month 6
Title
Exploratory--Perceived effectiveness, quality, reach, and usefulness of general prevention approaches, Qualitative
Description
This exploratory outcome will be assessed qualitatively through interviews with organizational leaders and staff
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parissa J Ballard, PhD
Phone
336-716-0793
Email
pballard@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor Arnold
Phone
336-713-5019
Email
tjarnold@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parissa J Ballard, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parissa J Ballard, PhD
Phone
336-716-0793
Email
pballard@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Taylor Arnold
Phone
336-713-5019
Email
tjarnold@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Parissa Ballard, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
Citation
Erikson, E. H. Identity: Youth and crisis. (WW Norton & Company, 1968).
Results Reference
background
PubMed Identifier
8442578
Citation
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.
Results Reference
background
PubMed Identifier
2042607
Citation
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.
Results Reference
background
Citation
Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 47, 53-68 (1991).
Results Reference
result

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Organization-level Youth Engagement Approach for Substance Misuse Prevention

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