Organization-level Youth Engagement Approach for Substance Misuse Prevention
Phase: NA
Conditions: Drug Use, Substance Use, Opioid Use, Substance Misuse
Sponsor: Wake Forest University Health Sciences

Official Title:  Youth Engagement as a Strategy in Substance Misuse Prevention: Open Trial & Randomized 
Controlled Trial
NCT05736211
IRB Approval Date:  09/19/24

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Study Title: Organization-level Youth Engagement Approach for Substance Misuse Prevention 
Principal Investigator, Co-investigator(s): Parissa Ballard, PhD, PI; Stephanie Daniel, PhD, 
Co-I 
Sponsor or funding source: NIH (National Institute of Drug Abuse) 
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 (Erikson, 1968). 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 
(Eccles et al., 1991, 1993; Farrow, 1991). Further, community systems and settings that serve 
YAs 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 YAs. This project tests an organization-level Youth 
Engagement (YE) approach to improve prevention.  
Objectives 
Phase 1: 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: 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.   
Methods and Measures 
Design 
Phase 1 will consist of a small open trial.  We will implement an organization-level YE 
prevention strategy by systematically incorporating YE into prevention efforts in a 
community setting. We will assess feasibility, acceptability, and usability to the community 
organization and to the young people with whom it works.  The results of Phase 1 will inform 
Phase 2. 
Phase 2 will consist of a small pilot RCT. Four prevention organizations will be randomized 
either to include YE in prevention efforts (treatment) or not (control). We will attempt to 

 
 
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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 YE involvement. 
 
Setting 
This study will be conducted with community-based prevention organizations. 
 
Subjects selection criteria 
Participants will consist of leaders or staff from community-based prevention organizations, 
as well as youth/YAs who are engaged as volunteers with the organization’s opioid misuse 
prevention efforts.  These youth/YAs will consist of a community sample, not clients at risk 
or in recovery for substance misuse.  The below criteria apply to both Phase 1 and 2. 
 
Inclusion Criteria:   
Organizational leaders/staff 
• 
Leaders or staff of community-based prevention organizations  
• 
Organizations are youth/YA-serving and focused on opioid misuse prevention 
• 
Organizations demonstrate readiness, interest, need, and resources to invest in YE 
as part of prevention 
• 
Leaders or staff are or would be involved in implementing YE strategy at the 
organization 
• 
Leaders or staff are able to speak and read English fluently 
 
Youth/YA participants involved with organizations 
• 
Adolescents and YAs age 11 – 29 
• 
Interested in participating in YE with the community organization 
• 
Able to speak and read English fluently 
 
Exclusion criteria:   
• 
Organizations already incorporating a high level of YE in their prevention work 
  
Sample size 
Phase 1 
We plan to enroll up to 3 leaders/staff and up to 15 youth/YA participants working 
with one organization.   
 
Phase 2 
We plan to enroll up to 3 leaders/staff from each of four organizations (two of the 
organizations will receive the intervention, two will be control groups). For each 
organization randomized to receive the intervention, we will also enroll up to 60 
youth/YA participants. 
 
Total 
Across both phases, we plan to enroll up to 15 organizational leaders/staff and up to 
120 youth/YA participants, for a total possible N of up to 135 people.   
 

 
 
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Interventions and Interactions 
All interviews will be conducted by study staff and may occur in-person, by telephone, or 
by video call, based on logistical considerations and participant preference.  Interviews 
will be audio-recorded for transcription purposes.  Interviews may be conducted 
individually or in groups and should last 30 minutes, and no more than 60 minutes. All 
surveys will be completed electronically via REDCap and should last around 20 minutes.  
Study staff will also periodically conduct and audio-record problem-solving check-ins 
with organizational leaders/staff. 
 
Phase 1 
For organizations, feasibility data will be collected of organization leaders/staff who are 
involved in implementing the YE strategy, via one survey and one interview per 
leader/staff.  The organization will be paid $250 for their participation in the open trial. 
This token of appreciation is for the leaders/staff’s time spent engaging with study staff 
and providing feasibility data through interviews and written feedback.    
 
Study staff will administer (or we will train organization staff to administer) surveys via 
REDCap to assess their impressions of their YE work as well as constructs such as self-
efficacy, connection, and knowledge about substances.  Each survey should require no 
more than 30 minutes each and youth/YA participants will be paid a $15 gift card (e.g., 
Amazon) upon completion. The YE strategy manual will be revised based on information 
learned from the feasibility data. 
 
The timeframe for this phase will be 6-12 months. 
 
Phase 2 
We will follow similar interview and survey data collection procedures as in Phase 1, 
with adaptations as needed based on participant feedback.  However, 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 we 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.  Youth/YAs will be paid $10 for the pre-YE survey, $15 for the post-
YE survey, and $25 for an interview (for a subset of youth/YA), for a maximum total of 
$50 in gift cards. 
 
The timeframe for this phase will be 12-18 months. 
 
 
 
 
Outcome Measure(s) 
Phase 1 
For organizations, information collected from staff via surveys and interviews will 
include: the facilitators and barriers of incorporating YE into prevention, the acceptability 

 
 
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of the strategy, evaluation of the support and resources available and what else would be 
needed to successfully implement YE, and perceived usefulness for YAs and the 
organization.  
 
For the youth/YAs, information collected via surveys will include: skills (e.g., leadership, 
communication) and attitudes (e.g., self-efficacy, social connectedness, self-confidence, 
meaningful social role) as well as knowledge and views of substance misuse. In 
interviews, we will ask youth/YAs about the facilitators and barriers of participating in 
the prevention effort, the acceptability of the YE strategy, evaluation of the experience 
working with the community organization, and likelihood of continued participation. For 
both organizations and individuals, feasibility data will be collected regarding retention 
of youth/YAs in the prevention work. 
 
Phase 2 
For organizations, information collected from staff via surveys and interviews will 
include:  perceived value added to prevention programming; retention of YAs in 
prevention programming; reach of prevention efforts in the community; perceived 
usefulness of YE to the organization, the YAs, and to the community; and perceived 
effectiveness of incorporating YE into prevention efforts.  
 
For the youth/YAs, information collected will include: skills (e.g., leadership, 
communication) and attitudes (e.g., self-efficacy, social connectedness, self-confidence, 
meaningful social role) as well as knowledge and views of substance misuse. The 
outcomes will be measured through self-reported surveys. These will serve as 
benchmarks that the YE intervention has the intended effect at the individual 
(psychosocial) level.  
 
Analytical Plan 
 
Phase 1 will examine descriptive statistics collected via surveys (from organizational staff 
and youth/YAs) and exploratory themes collected from interviews.  
 
Phase 2 analyses will examine the effects of the YE prevention strategy on organization 
level outcomes such as perceived value of YE added to prevention programming, and 
secondarily, on individual level skills and attitudes of the youth/YAs involved in the YE.  We 
hypothesize that YE-involved youth/YAs will show gains in skills (leadership, 
communication) and attitudes (self-efficacy, social connectedness, self-confidence, 
meaningful social role) as well as more knowledge and less favorable views of opioid misuse 
(compared to “pre” measures). These data will be used to estimate the effect sizes needed to 
power a larger study. These data will serve as additional information about the recruitment, 
feasibility, retention, fidelity and acceptability of the intervention. Comparison between 
groups will be done using chi square tests for proportions, and t-tests or ANOVA procedures 
for continuous variables.  Regression analysis will be performed to identify independent 
outcome predictors.  Other inferential statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 

 
 
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Subject Recruitment Methods 
Community-based prevention organizations will be invited to submit an application to 
participate.  Study staff will select viable candidates based on the eligibility criteria listed 
above.  Participating organizations will be asked to select their leaders or staff who will 
participate in the study, which includes completing interviews.  Organization staff will also 
invite their youth/YA volunteers to participate in the study and will forward the contact 
information of those interested to study staff via a secure transmission method (e.g., 
REDCap, fax, HIPAA-compliant cloud platform, direct phone call, postal mail, encrypted 
email).  Study staff will receive contact information only for youth/YAs who have provided 
verbal approval to participate.  We will attempt to recruit a minimum proportion of women 
and minorities corresponding to the populations from which we are drawing. Minors will be 
given a form to take home to their parent/legal guardian that explains the study and allows 
them to opt out of the study on behalf of their child. All forms will have contact information 
for the Project Manager of the study so that potential participants and/or parents/guardians 
can contact study staff with any questions.  
 
Informed Consent 
We are requesting a waiver of signed consent/assent, given that this study presents no more 
than minimal risk of harm to participants and involves no procedures for which written 
consent is normally required outside of the research context.  Participants will be provided 
with an information sheet (e.g., via REDCap, email, or paper) containing the relevant 
information necessary for them to make an informed decision about study participation. 
 
Study staff will distribute information sheets to each organizational leader/staff participant 
and instruct organizational staff to distribute the information sheet to the youth/YAs with 
whom they decide to work.  This may occur in-person or remotely via REDCap.  
 
We are requesting a waiver of parental consent for minor youth to participate, given that the 
study population will consist of a community sample of adolescents, the survey and interview 
questions will consist of routine psychological questions and therefore present no more than 
minimal risk, we are recruiting adolescents through an organization with established 
relationships with their youth volunteers, we are providing notification to parents and an 
avenue for parents to opt out (see Subject Recruitment Methods above), and we anticipate 
that it would be difficult logistically to access parents for consenting. While we anticipate 
that most youth will be involved in community organizations rather than schools, some may 
be connected to school-based programming. We recognize that some school districts may 
require active parental permission. Therefore, we will obtain active parental permission in 
cases where it is required by a particular school district or organization.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that 
could directly identify subjects, and maintaining all study information in a secure manner.  
We will collect some identifiable information on the self-administered online survey so we 
can link youths’ pre and post surveys. Upon receiving identifiable surveys, we will assign 
them a Participant Identification Number.   Any collected patient identifying information 

 
 
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corresponding to the unique study identifier will be maintained on a linkage file, store 
separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Participant identifying information will be kept for at least three 
years following study closure, then deleted or destroyed, consistent with data validation and 
study design, producing an anonymous analytical data set.  Data access will be limited to 
study staff.  Data and records will be kept locked and secured, with any computer data 
password protected.  No reference to any individual participant will appear in reports, 
presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator (PI) will be responsible for the overall monitoring of the data and 
safety of study participants.  The PI will be assisted by other members of the study staff and 
her project mentorship team consisting of a clinician and substance misuse specialist.  
 
The PI will develop a protocol for reporting adverse events. If any of the youth/YA 
participants report clinical concerns or issues in the course of interviewing them, the PI will 
consult with co-investigator Dr. Daniel (licensed clinical psychologist) and will offer a 
referral to services as needed.  We will develop an adverse event reporting form specific to 
this project and the nature of the intervention. The PI will monitor the progress of the trial 
and safety of participants on an ongoing basis and all study staff and investigators will be 
responsible for the reporting of possible adverse events. Using institutional guidelines 
(adapted from other sources), an adverse event is defined as “an undesirable and unintended 
result of therapy, intervention or interaction experienced by a subject participating in a 
research study.” An unexpected adverse event is defined as “any adverse event, the 
specificity, severity, frequency or nature of which is not consistent with the general 
investigational protocol or protocol amendments.” A serious adverse event is defined as 
“any adverse event that results in any of the following outcomes: death, a life-threatening 
adverse event, hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect.” Medical events that do not result in death, are not life-threatening, and 
do not require hospitalization may still be classified as serious adverse life events when they 
“jeopardize the patient or subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition.” The PI and her mentorship team will determine 
whether the relationship of the adverse event to the treatment study is “not related,” “possibly 
related,” or “definitely related” using standard institutional criteria for clinical trials.  
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government organization if appropriate. 
 
References 
Eccles, J. S. et al. Control versus autonomy during early adolescence. Journal of Social Issues 
47, 53-68 (1991). 
 

 
 
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Eccles, J. S. et al. Development during adolescence: The impact of stage-environment fit on 
young adolescents' experiences in schools and in families. American Psychologist 48, 90-101, 
doi:doi.org/10.1037/0003-066X.48.2.90 (1993). 
 
Erikson, E. H. Identity: Youth and crisis.  (WW Norton & Company, 1968). 
 
Farrow J. A. Youth alienation as an emerging pediatric health care issue. American Journal of 
Diseases of Children 145, 491-492 (1991). 
 
Lord, S., Brevard, J. & Budman, S. Connecting to young adults: an online social network survey 
of beliefs and attitudes associated with prescription opioid misuse among college students. 
Substance Use & Misuse 46, 66-76 (2011). 
 
McCabe, S. E., Cranford, J. A., Boyd, C. J. & Teter, C. J. Motives, diversion and routes of 
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562-575 (2007).