A Pilot Trial of a Network Intervention for Youth After Incarceration
Phase: NA
Conditions: Youth Incarceration, Health Care Utilization
Sponsor: University of California, Los Angeles

Cover Page for ClinicalTrials.gov  
 
Official Study Title: 
A Pilot Trial of a Network Intervention for Youth After Incarceration 
NCT Number: 
NCT03556618 
Document: 
Study Protocol     
Document Date:  
October 28, 2020 
  

Study Protocol 
(Amended 10.28.2020) 
 
TABLE OF CONTENTS 
I. 
Funding…………………………………………………………………………….2 
II. 
Lay Summary…………………………………………………………..…………..2 
III. 
Background and Significance……………………………………………………...3 
IV. 
Hypothesis and Specific Aims……………………………………………………..5 
V. 
Research Design and Methods……………………………………………………..6 
VI. 
Characteristics of the Study Population………………………………………........11 
VII. 
Study Data and Security…………………………………………………………....12 
VIII. 
Privacy and Confidentiality………………………………………………………...13 
IX. 
Benefits & Risks…………………………………………………………………...15 
X. 
Data & Safety Monitoring Plan……………………………………………………16 
XI. 
Payments & Cost…………………………………………………………………...16 
XII. 
HIPAA Authorization……………………………………………………………...17 
XIII. 
Recruitment Methods………………………………………………………………17 
XIV. 
Permission & Assent Process for Minors and Informed Consent………………….18 
XV. 
Cultural Considerations…………………………………………………………….20 
XVI. 
Additional Information……………………………………………………………..20 
 
 
 
 
 
 
 

 
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I. 
Funding 
The research study is funded by the National Institutes of Health (NIH)—National Institute 
on Drug Abuse (NIDA) through a K23 Career Development Award and a grant from the 
California Community Foundation (CCF) to Dr. Barnert.  
II. 
Lay Summary 
The proposed study intervention, UCLA WPC-LA Transition Age Youth (TAY) Reentry 
Study, adapts the successful evidence-based adult Transitions Clinic model to youth. We 
hypothesize that re-wiring adolescent social networks during community reentry can 
potentially break the vicious cycle of adolescent substance use and youth incarceration. 
To test our hypothesis, we are collaborating closely with the LA County Health Agency and 
the Probation Department to develop and measure the impact of a network coach intervention 
(termed “Whole Person Care (WPC)” by DHS) to reduce adolescent substance use and other 
markers of healthy reintegration among recently incarcerated adolescents. We will also test 
the potential mechanism of enhanced social networks during reentry as mediating youths’ 
success in reducing substance use.   
We will invite 200 youth to participate: 160 transition age youth (TAY) exiting LA County 
jails (ages 18-24, 80 receiving and 80 not receiving the WPC intervention), and 40 TAY 
exiting the juvenile justice system (ages 16-19).  
This study will use an observational survey research design to understand the 
interrelationships between social networks, substance use, and care utilization for TAY who 
transition home following incarceration. A mixture of closed-ended surveys along with open-
ended focus group discussions will be used. Participants will be asked to complete three 
surveys (baseline, as well as 3 and 9 months post-release). For TAY exiting jail, baseline 
surveys will be conducted while detained. For TAY exiting the juvenile justice system, 
baseline surveys will be conducted in the community, up to one month after their release 
from incarceration. From the surveys, the research team will identify participants with high 
and low health service utilization, and invite them to participate in one focus group interview. 
Participation in the study will take up to 3 hours, which includes survey completion and 
focus group participation.  
Medical records, with limited information, will also be requested from LA Department of 
Health Services for adults eligible for the Whole Person Care intervention.  
Study Title: 
UCLA WPC-LA Transition Age Youth (TAY) Reentry 
Study 
 
Study Site: 
UCLA 
Other Sites and/or Collaborators: Los Angeles (LA) County Health Agency and Los 
Angeles (LA) County Probation Department  
Key Words:  
juvenile reentry, substance abuse disorders, 
intervention, adolescent health, social networks 

 
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Furthermore, we intend to assess the intervention’s fidelity by observing youth-WPC coach 
interactions and inviting at least 5 WPC coaches to participate in surveys and interviews. 
This will also help assess the coaches’ perceptions of successes and challenges with 
adherence to the WPC protocol. Coaches will be invited to participate in the study through a 
separate consent process.  
Amendment 05/27/20: 
In response to COVID-19, we will conduct monthly qualitative interviews with the 19 
participants that are currently enrolled in the study. Interviews will be done over the phone 
until we are permitted to resume in-person procedures. We will also add an additional time 
point for when we administer the follow-up survey, 1-month post release. 
Amendment 10/28/2020: 
Due to the ongoing COVID-19 pandemic, we are now going to be using remote recruitment 
and consent produces for young people exiting jail and will resume an in-person option as 
soon as it is safe to do so. The WPC team will provide potential participants with a study 
authorization form that includes information about the study. If potential participants are 
interested, they will be required to provide a signature in order have the WPC team share 
their contact information with the UCLA study team. The UCLA study team will then 
remotely recruit interested participants and will obtain verbal consent to participate in the 
study. Because of this, we are changing the times at which the baseline and follow-up 
surveys are administered. Participants will now complete surveys 2 weeks after release and 
then two, four, and six months after release. 
Background and Significance 
Untreated adolescent substance use disorders (SUD) lead to youth incarceration. US law 
enforcement makes 1.3 million juvenile arrests annually. Of the nearly 51,000 youth in 
juvenile detention on a given day, 50-88% have SUD. Adolescent SUD are often comorbid 
with mental health problems, which substantially elevates risk of youth incarceration, and 
70% of detained youth report prior trauma exposure, heightening behavioral health risks. 
Untreated adolescent SUD directly lead to incarceration for drug-related charges and is 
strongly associated with non-drug offending. Adolescent substance use, mental health 
disorders, and youth incarceration are highly intertwined. 
Incarceration exacerbates existing behavioral health problems, feeding a vicious cycle. The 
experience of incarceration itself can worsen youths’ existing mental health problems, such 
as depression, and increase future risk of substance use, likely due to the psychological 
trauma of incarceration and the potential negative social influences within detention settings. 
Our analyses of the Add Health dataset support a potential causal linkage between 
incarceration and worse behavioral health outcomes. We found that, compared to no 
incarceration, youths’ lifetime incarceration duration greater than 1 year significantly 
predicted subsequent adult depression (OR= 2.8) and adult suicidal thoughts (OR= 2.3), 
controlling for baseline mental health, substance use, and other key covariates. We also 
found that odds of heavy alcohol use were 9-11 percentage-points higher among incarcerated 
cases than among non-incarcerated matched controls at an individual’s first post-
incarceration wave (p<0.001); odds of other drug use were 18-26 percentage-points higher 
(p<0.001); and depressive symptoms (CESD-R20) scores were 0.39 – 1.17 points higher 
(p<0.001). 

 
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Re-entry, the period when youth transition from detention facilities back to the community, 
represents a critical juncture and a high-risk period for re-engaging in substance use. In total, 
88,000 detained youth are released annually in the US, most of whom are poor and of color. 
Within 3 years of release, 75% of adolescents are re-arrested, with highest risk among youth 
with SUD. Adolescent SUD presence and severity strongly predict re-arrest and less time 
attending school or being employed. Thus, adolescent SUD not only lead directly to 
incarceration, but also contribute to low educational attainment and future unemployment, 
which further increase lifetime incarceration risk and perpetuate individual and 
intergenerational social disadvantage. Furthermore, the risk of mortality in the first 2 weeks 
after release for adult former prisoners is 3.5 times that of the general adult population, with 
the leading cause of death being drug overdose, most commonly cocaine, psychostimulants, 
and opioids. Formerly incarcerated youth similarly demonstrate high premature mortality. 
Although many youth express plans to reform and to stay “clean” from drugs upon release 
from detention, the challenges of returning to chaotic and even dangerous home 
environments while simultaneously transitioning out of probation schools and correctional 
health systems—all while confronting the normal developmental tasks of adolescence—
make healthy reentry extremely difficult without adequate supports and clinical treatments. 
Breaking the vicious cycle of adolescent substance use and youth incarceration requires 
effective linkages to substance use treatment programs during community reentry. Studies 
have repeatedly demonstrated that behavioral health treatment is effective in treating 
adolescent SUD and reducing recidivism, and is associated with improved educational and 
vocational outcomes, yet many recently incarcerated youth fail to access these services. 
Among recently incarcerated youth with a behavioral health disorder, only 34% access 
behavioral health services during the 6-month reentry period and receive services an average 
of only 2 out of every 100 days. Family functional therapy and multisystemic therapy are 
cost-effective interventions that reduce substance use and recidivism and increase school 
success and employment. The effectiveness of these services is encouraging, but many youth 
do not receive these services. All youth, by law, have access to healthcare while incarcerated, 
but no consistent care is required following release. However, access to regular care often 
stops when incarceration ends, making reentry a missed opportunity for connecting youth to 
needed behavioral healthcare. Enhancing youths’ connections to effective substance use 
treatment programs is crucial. Interventions that link reentry youth to substance use treatment 
need to take into account the unique context of reentry—a time when youth navigate shifts in 
personal relationships and support networks. 
Social networks powerfully influence adolescent substance use and delinquent behavior—
and reentry is a natural time to re-set social networks. Strong evidence indicates that 
adolescents’ substance use is closely tied to the behaviors and attitudes of individuals in their 
social network. As described by Social Influence Theory, social network structure and 
composition are shaped by cultural and environmental factors. In the reentry context, these 
factors include, for example, policies that dictate probation monitoring regarding who 
adolescents can associate with. Social networks then determine sources of support, 
transmission of social norms, and access and opportunity to engage in substance use. 
Although peers are powerful points of influence during adolescence, relationships with 
supportive adults can protect against substance use. 
Despite great interest in social networks as potential determinants of risky behaviors, we 
have yet to fully characterize the causal pathways linking social networks with adolescent 
health. Studies suggest that changes in social networks can impact substance use, but little is 
known about how to harness this relationship effectively. Answering this question may have 

 
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applications across many social environments and health domains. Interventions that re-wire 
social networks might offer a relatively low-cost, self-sustaining, and effective means to 
prevent some of the most challenging behaviors that lead to poor health outcomes.   
III. 
Hypothesis and Specific Aims 
This community-partnered study seeks to explore, describe, and measure the implementation 
and impact of an innovative pilot intervention, the Whole Person Care (WPC) Program, a 
network coach intervention that addresses two key challenges for recently incarcerated 
youth: poor care coordination in the “behavioral health cascade” and need for more positive 
support from the social network. Los Angeles (LA) County has the largest justice system in 
the US and has begun implementing the WPC network coach intervention to enhance 
linkages to community behavioral health services. WPC is based on the successful 
Transitions Clinic model, an intervention with demonstrated efficacy in linking recently 
incarcerated adults to needed healthcare and improving health outcomes. The model has yet 
to be implemented for reentry youth, but has the potential to be transformative at the critical 
developmental stage of adolescence, when peer social networks are highly dynamic and 
youth behaviors can affect lifelong trajectories. WPC network coaches will receive 
formalized training modeled after the adult Transitions Clinic approach and will serve as a 
formerly incarcerated adult role model who provides care coordination and social support to 
facilitate access to needed behavioral health services. Tailored for reentry youth, WPC will 
also include a social network component whereby coaches are trained to actively guide youth 
toward pro-social peers and adults. The Principal Investigator, Elizabeth Barnert, has been 
working closely with LA County and this study capitalizes on a unique opportunity to study 
the WPC program. We propose an exploratory and observational study of WPC, using a 
community-partnered, participatory research (CPPR) approach. While we anticipate that this 
data collection and analysis will have sufficient power to detect differences between groups, 
the relative paucity of information known about this topic and this study population ensure 
that the data collected will be novel and provide an opportunity to inform intervention design 
and refinement. 
Specific aims are to: 
1) Describe the social networks of transition-age youth (TAY) exiting jail or juvenile 
detention. 
Hypothesis 1: Participants will describe their social networks. We expect that social networks 
will include individuals who have a history of substance use, as well as individuals who do 
not have a history of substance use and/or discourage the use of substances. 
2) Measure the impact of the Whole Person Care (WPC) intervention for TAY exiting jail in 
decreasing rates of 30-day use and risky use of marijuana and alcohol.  
Hypothesis 2: Incarcerated youth enrolled in the WPC intervention will have less substance 
use 3 and 9 months post-release compared to their peers who are not receiving the WPC 
intervention. 
3) Test whether the WPC intervention decreases recidivism and increases receipt of 
behavioral health services (secondary outcomes). 
Hypothesis 3: Youth participating in WPC will have less recidivism and higher rates of 
receipt of behavioral health services.  

 
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4): Examine whether recently incarcerated youth receiving the WPC intervention report 
healthier social networks (lower proportion of peers engaging in risky behaviors and a higher 
number of supportive adults) than control youth.  
Hypothesis 4: Youth receiving the WPC intervention will have a lower proportion of peers 
engaging in substance use and a higher number of supportive adults in their social networks 
compared to their peers in the control group. 
5) Identify effective approaches for achieving linkages to care during reentry for TAY who 
have high community health service utilization versus low community health service 
utilization. 
Hypothesis 5: TAY will describe the interrelationship between social networks, substance 
use, and care utilization, providing insight that can guide the development and 
implementation of a social network intervention to reduce TAY substance use during reentry. 
IV. 
Research Design and Methods 
We will use a community-partnered participatory research (CPPR) approach, collaborating 
closely with the LA County Health Agency and the Probation Department to develop and 
measure the impact of a network coach intervention to reduce adolescent substance use and 
other markers of healthy reintegration among recently incarcerated adolescents. We will 
conduct an observational study to help us gain insight of the intervention, including the 
implementation and study population. Note: There are two populations in this study: (1) 
Transition age youth (TAY), ages 18-24, exiting the adult criminal system and (2) TAY, ages 
16-19, exiting the juvenile justice system. Study methods for each population are described 
below, starting with the adult population.  
**TAY Exiting the Adult Criminal System (ADULT POPULATION)** 
Study population: 
Participants who are eligible for the Whole Person Care—Los Angeles (WPC-LA) Reentry 
post-release program will be eligible for the adult population of this study. The WPC Reentry 
program, implemented by the Los Angeles County Health Services Department, links jail 
inmates with community-based health, behavioral health, and social service providers as they 
return to the community. The intervention connects participants to Community Health 
Workers (CHWs) with a prior personal history of incarceration. CHWs assist participants in 
engaging with community-based health, behavioral health, and social service providers 
during reentry to the community. Services provided include mentorship and social support; 
health and social service navigation; linkage to housing, employment, education, legal 
assistance and social supports; accompaniment to key health and behavioral health 
appointments; assistance with adherence to appointments, treatments and medications; and 
connection to transportation. The mentorship and social support aspects of the intervention 
will indirectly target the social networks of participants. The WPC intervention is an existing 
intervention. The WPC intervention enrolls 750 individuals per month across LA County; 
approximately 12% are transition age youth ages 18-24. Participants are invited to this 
program while detained by the WPC case manager. Thus, WPC is a voluntary program. The 
WPC case manager is responsible for determining eligibility for the WPC reentry program 
and enrollment in the WPC program, not the research staff.  
Recruitment and Consent: 

 
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We will recruit 160 adults exiting the LA county justice system – 80 who have enrolled in 
the WPC program and 80 have not. We anticipate enrolling participants over an approximate 
9 month window, aiming to recruit about 9 individuals per arm (WPC and non-WPC) each 
month. This represents approximately 10% of the eligible population each month for each 
arm. 
Potential subjects will be identified as follows: (1) The research associate (RA) will shadow 
the WPC case manager as she invites participants to enroll in WPC. (2) The RA will then 
approach and ask potential WPC participants if they are interested in participating in the 
study, regardless of whether they accept to enroll in the WPC program or not. If the 
participant opts in to the WPC intervention, he/she will be placed in the “intervention” group 
of the study; if the participant opts out of the WPC intervention, he/she will be placed in the 
“non-intervention” group of the study. (3) If the participant is interested in participating in 
the study, the RA will confirm the age of the participant (must be between the ages of 18-24) 
and assess whether there are no severe cognitive delays based on communication with the 
participant.  
If eligible, the RA will review the study with the interested participant and obtain written 
consent. Furthermore, the RA will obtain a signed HIPAA authorization form for research for 
medical record access to allow for later record review and abstraction. The RA will remind 
the participant of the voluntary nature of the study and that participation in no way affects 
their standing with the Court, the Sheriff’s department, or their receipt of WPC.  
Data Collection: 
The RA will administer the baseline survey in a private area where respondents’ answers 
cannot be overheard. Surveys have been piloted with TAY not in jail and take an average of 
20 minutes to complete. Upon completion of the survey, the RA will ask for a telephone 
number and address to contact the participant after their release from incarceration. This 
information will be kept separate from the survey. To encourage follow-up, a $50 cash or gift 
card incentive (based on participant’s preference) will be given to participants if they contact 
the research team after their release. At this time, participants will also be provided with a 
copy of the consent and HIPAA authorization forms.  
Follow-up surveys will be conducted at 3 and 9 months post-release. These surveys will be 
conducted in-person or over the phone, based on participant’s preference, and are expected to 
last up to 30-minutes each. A $50 gift card or cash incentive will be given after the 
completion of each follow-up survey.  
Following study subject involvement (completion of surveys), medical record abstraction 
will be completed in partnership with LA County. We anticipate that this will be completed 
via a systematic data pull that includes information for all study participants that have signed 
a HIPAA authorization form. Thus, no abstraction form is included. Chart data will include: 
arrests, time spent incarcerated, recidivism, health services utilization – such as 
hospitalization and treatment, health diagnoses, as well as uptake / utilization of the WPC 
program. This information, in conjunction with data collected via survey administration, will 
be used both as covariates to help control for any difference between the intervention and 
control groups as well as for outcomes data related to behavioral health uptake and 
recidivism. 
Amendment 5/27/20: 

 
8 
 
Qualitative Interviews and Follow-up Survey 
Due to COVID-19 pandemic, we are suspending all in-person procedures until allowed to 
resume. During this time, we will be conducting up to 9 monthly qualitative interviews over 
the phone with the 19 participants who are currently enrolled in the study; we have also 
added another time point for when the follow-up survey will be administered: 1 month after 
release. We have created an addendum consent and those participants that are currently 
enrolled will be asked, over the phone or in-person when permissible, whether or not they are 
interested in participating in the new study procedures. If they are interested, the RA will 
obtain verbal consent. Participants will receive $25 for each of the qualitative interviews 
completed. They will also receive $50 for completing the additional follow-up survey. 
Amendment 10/28/20: 
Recruitment and Consent: 
In order to minimize in-person contact due to the COVID-19 pandemic, we are not going to 
recruit and consent participants remotely. We will resume an in-person option when it is safe 
to do so. The WPC team will identify potential participants who are about to exit jail and will 
provide them with the study authorization form that includes information about the study. If 
potential participants are interested in participating in the study, they must sign the study 
authorization form that would allow the WPC team to share their name and contact 
information with the UCLA study team. Once the UCLA study team receives this 
information, a research assistant will then contact potential participants and continue with 
remote recruitment procedures. If eligible, the RA will review the study with the interested 
participant and obtain verbal consent. The RA will remind the participant of the voluntary 
nature of the study and that participation in no way affects their standing with the Court, the 
Sheriff’s department, or their receipt of WPC.  
Data Collection: 
The RA will administer the baseline survey, over the phone, 2 weeks after release in a private 
area where respondents’ answers cannot be overheard. The survey will take approximately 
30 minutes to complete. The RA will also conduct follow-up surveys two, four, and six 
months after release. Participants will receive $50 for each survey that is completed, for a 
total of up to $200. During the COVID-19 pandemic, to minimize in-person contact, 
participants will have the option of receiving these incentives through the mail or through 
payment apps (Venmo, Zelle, CashApp, etc.), depending on their preference. Once it is safe 
to do so, we will also allow for in-person delivery options. 
Previously, our study team was going to be performing chart abstractions from LA 
Department of Health Services records for those enrolled in the Whole Person Care initiative, 
but we have chosen to not move ahead with this. We will no longer be asking study 
participants to sign HIPAA authorization forms. 
 
**TAY Exiting the Juvenile Justice System (JUVENILE POPULATION)** 
Recruitment and Consent: 
We will recruit 40 youth exiting the juvenile justice system.  

 
9 
 
Potential subjects will be identified as follows: (1) the Los Angeles County Department of 
Probation will provide the research team the names and contact information of youth ages 16 
to 19 exiting incarceration and returning home to the Centinela Valley of Los Angeles, 
California. A weekly list of names and telephone numbers will be emailed via a protected 
excel file. Probation will also give youth returning home a flyer informing them of the study. 
(2) The study team will review the list provided by Probation to identify those that may be 
eligible based on age and zip code. (3) The Office of the Head Public Defender will contact 
youths to notify them of the study, utilizing the scripted Study Information Sheet, and ask if 
the youth would provide permission for being contacted by the UCLA study team. (4) If the 
youth provides permission for contact for the study, the Public Defender will notify the 
UCLA study team. The RA will then call the numbers provided and determine eligibility (i.e. 
between the ages of 16 and 19, fluent in English or Spanish, living in the Centinela Valley, 
no severe cognitive delay). (5) If the youth is interested and eligible, verbal assent and 
parental permission will be obtained (note: youth ages 18 years of age and older can provide 
consent). The PI has experience with this method of data collection (UCLA IRB application: 
15-001698). Wards of the state will not be invited to participate.  
Data Collection: 
The RA will administer the baseline survey over the phone or in-person, depending on 
participant’s preference. Surveys have been piloted with TAY not in jail and take an average 
of 20 minutes to complete. Upon completion of the survey, the RA will mail a $50 gift card 
or cash incentive, based on participant’s preference, to compensate them for their time. 
Copies of the parental permission and assent or consent will be provided to the participants’ 
along with the study incentive. Follow-up surveys will be conducted at 3 and 9 months post-
release. These surveys will be conducted in-person or by phone, based on participant’s 
preference, and are expected to last up to 30-minutes each. A $50 gift card or cash incentive 
will be given after the completion of each follow-up survey.  
FOCUS GROUPS 
The research team will also invite a sub-set of survey participants from the Centinela Valley 
(eligible zip codes included as an attachment) to participate in focus groups outside of 
detention. Participants will be asked to participate in one focus group, lasting up to one-hour. 
Based on survey results, focus groups will be purposefully designed to include groups with 
individuals who are high versus low care utilizers. Utilization rates will be determined based 
on both youth survey responses and medical record abstraction. These rates will then be 
reviewed by the study data analyst and investigators to determine the appropriate cut point 
for the dichotomization of health services utilization. Two focus groups will be conducted 
with TAY who exited the county jail and two other focus groups will be conducted with 
youth who were released from the juvenile justice system.  
Time required of subjects: 
Total time: up to 3 hours 
Recruitment and consent: 10 minutes 
Baseline survey: 30 minutes 
3-month follow-up survey: 30 minutes 

 
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6-month follow-up survey: 30 minutes 
Focus group interview: 60 minutes (optional) 
Fidelity of the Intervention: 
We will utilize 2 methods for assessing fidelity of the intervention: 1) Youth surveys: the 
follow-up youth surveys for those in the intervention group will include a WPC fidelity form 
to assess whether core components of the intervention occurred, including measuring the 
frequency and duration of interactions with coaches, youths’ perceptions of coaches and the 
usefulness of the WPC program. 2) Coach surveys and interviews: Network coaches will 
complete a WPC fidelity form (survey) and we will conduct qualitative interviews with 
network coaches to assess their perceptions of successes and challenges with adherence to 
the WPC protocol. Only interviews with coaches will be audio recorded. Coaches will have 
the opportunity to listen, edit, and delete the recordings. These assessments will provide 
information for refinement of the intervention and pilot data to inform the R01 submission. 
Statistics and Data Analysis 
For the main outcome, percentage of days used marijuana in the last 30 days (Aim 2), we 
will conduct a linear mixed effects regression model to account for repeated measurements 
within individual youth. We will perform unadjusted and adjusted comparisons, controlling 
for baseline demographic (race/ethnicity, age, parental SES) and substance use 
characteristics, as well as any variables found to be differential between the intervention and 
control groups. Similar analyses will be carried out to examine the impact of Whole Person 
Care (WPC) on percentage days used alcohol, and risky use of marijuana and alcohol. Risky 
alcohol use will be defined using the Edelen (2009) measure of Adolescent Alcohol Misuse, 
which has also been adapted for use with marijuana (Dudovitz, 2019). The index assesses 
behaviors in the prior 12 months and ranges from 0–8, with higher scores representing more 
risky substance use. For each of the secondary outcomes, recidivism and receipt of SUD and 
mental health services (Aim 3), we will conduct generalized linear mixed effects regression 
models to account for repeated measurements within individual youth, while controlling for 
baseline demographic and SUD characteristics. We will also evaluate whether there is effect 
modification by baseline mental health symptoms, using interaction terms with the exposure 
variable in the regression analysis. Additionally, if analyses for Aims 2 and Aim 3 do not 
indicate improvement overall in the intervention group, we will conduct exploratory analyses 
to identify subgroups of youth whose Aim 2 and Aim 3 outcomes improve and examine their 
social networks. 
Using the quantitative surveys, we will also conduct a social network analysis, which will 
help determine why the intervention did or did not demonstrate the expected effect. We will 
measure how social networks function for youth and whether the insertion of a caring adult 
can create linkages to substance use services and promote healthier social networks. We will 
use the approach described in Baron and Kenny (1986) to evaluate whether our data are 
consistent with a model in which social networks mediate the relationship between WPC 
receipt and substance use. Primary social network measures will include the change in 
proportion of peers using substances (alcohol, marijuana, other drugs), limited to those whom 
the subject interacts with at least weekly. We will compare baseline social network 
characteristics of the intervention and control groups and control for these measures if 
significant differences are noted. To test whether youth receiving WPC report a lower 
proportion of peers in their network engaging in substance use, we will conduct a mixed 

 
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effects binomial logistic regression model accounting for repeated measurements within 
students. We will control for baseline demographic characteristics, as well as any variables 
found to be differential between the intervention and control groups. Furthermore, we will 
examine the number of non-using supportive adults in their network using a mixed effects 
binomial logistic regression model. We will also use mixed effects models to investigate 
whether network structure differs between study arms and whether intervention youth report 
stronger connections to healthy peers and adults.  
After completion of focus groups, we perform inductive thematic analysis to identify 
emergent themes. Results will be triangulated with the surveys.  
Sample size was determined based on power calculations and the feasibility of the budget in 
the pending grant. We plan to recruit and consent 160 TAY ages 18-24 exiting the adult 
criminal justice system and 40 TAY ages 16-19 exiting the juvenile justice system. 
V. 
Characteristics of the Study Population 
Maximum number of study participants we hope to enroll: 160 adults exiting the LA county 
justice system and 40 youth exited the juvenile justice system and 10 coaches/CHWs 
Inclusion criteria for TAY exiting the adult criminal system: 
1. Age 18-24 
2. Fluent in English or Spanish 
3. No severe cognitive delay 
4. WPC-eligible (eligibility for the WPC program is determined by the WPC team and is 
outlined under the “Determining Eligibility” paragraph.) 
Inclusion criteria for TAY exiting the juvenile justice criminal system: 
1. Ages 16-19 
2. Fluent in English or Spanish 
3. Not a ward of the state through the dependency system. (Note: some participants will be 
wards of the state through the delinquency system once home due to temporary formal 
probation monitoring). 
4. Reside in the Centinela Valley (eligible zip codes are provided as an attachment) 
 
Inclusion criteria for Focus Group Interviews 
1. Survey participants 
2. Reside in the Centinela Valley (eligible zip codes are provided as an attachment) 
3. High care or low care utilizer as determined by survey responses 
Exclusion Criteria: 
Exclusion criteria is inverse of inclusion criteria. 

 
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Determining Eligibility: 
For youth exiting the juvenile justice system, eligibility will be determined by the research 
associate (RA). After receipt of the list of potential study participants from Probation, the RA 
will review the list to assess eligibility for age and zip code and will then provide the list of 
the office of the Head Public Defender, who will contact youth to obtain their permission for 
UCLA study team contact. Following this, the UCLA RA will contact them and confirm 
whether the youth is between the ages of 16-19, speaks Spanish or English, and is not a ward 
of the state (i.e. returned home to a parent). Assessment of cognitive delay will also be 
conducted by RA.  
WPC staff will determine eligibility for the WPC intervention while the participant is 
detained. After WPC eligibility is confirmed, the research team will determine study 
eligibility.  
Eligibility criteria for the WPC intervention are:  
• Involvement with the justice system (pre-booking, probation, or incarceration) within 
the last 3 months; and 
• 1 Emergency Department visit in the past 6 months; or 1 hospital visit in the past 12 
months; and 
• At least one of the following: 
• Chronic medical condition; 
• Serious mental illness; 
• Substance Use Disorder; or 
• Homelessness 
Coach/CHW Inclusion Criteria: 
• Current network coach/CHW working for WPC 
• Coach/CHW consent to participate in study  
As long as coaches/CHWs are employed by WPC at the time of the study, are working with a 
youth, and consent to participate, they will be eligible to participate. Eligibility will be 
determined by the PI or RA staff. 
VI. 
Study Data and Security  
We will be asking subjects detailed information about substance use, mental health, and 
behavioral health services access. Some behaviors that we will assess are illegal, but we will 
take several steps to minimize the chances of learning something that would require 
mandatory reporting.  
To minimize the chances of learning something we would need to report, the consent 
discussions will clearly state things that would trigger reporting and we will make sure youth 
and parents understand this before moving on. We have also structured our study instruments 
to avoid collecting information that would ethically require action. We have modified the 
ACEs (adverse childhood experiences) screen to avoid questions that may reveal a concern 
for child abuse. We will also remind participants that their participation is completely 
voluntary and that they may choose to skip any or all questions that they do not feel 
comfortable answering.  

 
13 
 
The PI, a licensed clinician (Dr. Elizabeth Barnert, MD, MPH, MS) will be on call in cases 
where abuse is reported to RAs (i.e., non-clinicians). They can reach me immediately via my 
email address and/or work phone and cell phone. If I am away, I will notify the RAs in 
advance and they can direct immediate issues to my primary mentor, Mitch Wong, also a 
physician. He would similarly be available by email and/or work phone and cell phone.  
We do not anticipate that the study will lead to a report of a previously unaddressed 
reportable disease that requires action by our study team. 
WPC and Probation staff will provide the UCLA research team the following information for 
study recruitment purposes: Names, dates of release, telephone numbers, zip codes and e-
mail addresses. 
All study data will be coded and personal identifying information will be removed and 
destroyed. The PI and research assistants will use a unique ID number to identify the 
subjects’ survey and interview data. The link to the subjects’ personal identifying 
information and their ID number will be kept separate in a password protected file. 
We will not distribute data to any researchers outside of the study team. We will not 
distribute data to any individuals outside of the study team. 
Contact information received by the Los Angeles Probation Department will be transmitted 
electronically via an encrypted, password-protected file using the UCLA DGIT secure file 
transfer system. Data received from the Los Angeles Department of Health Services also be 
transmitted using the same mechanism or will be transferred via in-person hand-off between 
WPC contact and study team.  
Data will be stored on encrypted, password protected UCLA computers on a secure network 
server. Only the research team will have access to the data. 
Audio files will be securely transmitted via the internet to our HIPAA compliant 
transcription service. This will be done by uploading the files to a secure, firewall protected 
web address that can only be accessed by the study team and transcription service. Upon 
completion of transcription, the transcription service will be asked to promptly destroy all 
audio files. 
After the study is completed, personal identifiers and/or codes linking the data and/or 
specimens to personal identifiers will be maintained for future research for those participants 
who have provided prior permission for this. The information will be securely stored by the 
P.I. on the Divisions secure network server. Only the PI will have access to the link file and 
file that contains personal identifiers. These will be stored in two separate, password 
protected documents on the secure server used for the study. The link file will only be used to 
identify participants for future studies and will be stored separately from any data files so that 
identifiers will not be linked with survey responses. 
Participants may be contacted for future studies (e.g. including collect administrative data 
from Probation DMH in the future) 
Amendment 10/28/20: 
Contact information received from the Whole Person Care Program will be transmitted 
electronically via an encrypted, password-protected file using the UCLA DGIT secure file 

 
14 
 
transfer system. To protect participant confidentiality, these signed forms will be kept by 
WPC in a locked cabinet that only the WPC team can access. 
VII. 
Privacy and Confidentiality  
Privacy 
Surveys will be administered in areas where responses cannot be overheard and will be made 
available for participants to self-complete in the presence of the UCLA RA. If the survey is 
conducted over the phone, the research associate will ask the participants if this is an 
acceptable time to talk about their participation in the research study. Follow-up survey data 
may also be collected using a computer-assisted-self-interview (CASI) directly in a private 
setting. This provides greater privacy and has been demonstrated to elicit more accurate 
responses. Participants will be able to share as little or as much as they would like in the 
focus group interviews, allowing them control over their privacy.  
Coach participants will be interviewed in a private setting. Participants will be clearly 
informed of this procedure during the consent process.   
Amendment 05/27/20: 
Qualitative interviews will be administered over the phone during COVID-19 pandemic. 
There will be an in-person option once we are allowed to resume in-person interviews. The 
research associate will make sure to be in an area where responses cannot be overheard. The 
research associate will ask the participants if this is an acceptable time to talk about their 
participation in the research study. The 19 participants currently enrolled will be able to share 
as little or as much as they would like in the qualitative interviews, allowing them control 
over their privacy. 
Amendment 10/28/20: 
Surveys will be administered over the phone during COVID-19 pandemic. There will be an 
in-person option once we are allowed to resume in-person interviews. The research assistant 
will make sure to be in an area where responses cannot be overheard. The RA will ask the 
participants if this is an acceptable time to talk about their participation in the research study. 
Participants will be able to share as little or as much as they would like, allowing them 
control over their privacy. 
Confidentiality 
The UCLA research team will collect data via interview, access medical record data, and 
maintain full study data provided by participants who have consented to participate in the 
research study. 
Documentation of consent and HIPAA authorization will be stored in a locked file cabinet in 
the research office or in a secure network server with access limited to study personnel.  
Data collection instruments will be labeled with a unique study identifier. For focus groups, 
all participants will be asked to keep what is said during the discussion between participants 
only. However, complete confidentiality cannot be guaranteed, and participants will be 
informed of this in the consent form. Furthermore, focus group interviews will be recorded. 
Thus, we will temporarily have voiceprints. Audio recordings will be securely stored and 

 
15 
 
transmitted. Transcription will be done promptly after each interview. Audio-recordings will 
be destroyed upon completion of transcription. 
The file that links the study ID# with other identifying information will only be accessible to 
the study PI, study coordinator, and research associate and will be stored on an encrypted 
network drive in a password-protected file. The study database will be password-protected 
and only accessible to named study personnel who have completed appropriate HIPAA and 
human subjects research training. 
With the permission of the coach study participants, we will also audio record the coach 
interviews. Thus, we will temporarily have voiceprints. Audio recordings will be securely 
stored and transmitted. Transcription will be done promptly after each interview. Audio-
recordings will be destroyed upon completion of transcription. 
We will be collecting sensitive information including some information that if involuntarily 
released could pose a risk to subjects. Therefore, we will institute an Adverse Event Protocol 
(found under “Other” documents of this application).  
Amendment 05/27/20: 
With permission from the 19 study participants, the monthly qualitative interviews will be 
recorded. Participants will have the opportunity to listen to, edit, and delete recording of their 
monthly qualitative interviews. 
Amendment 10/28/20: 
The WPC team will ask potential participants if they are interested in the study and if they 
are, they will ask potential participants for a signature in order to share their contact 
information (name and phone number) with the UCLA study team. The signature obtained by 
WPC is not meant to enroll participants in the study, but rather it is meant to allow the WPC 
team to share contact information with the UCLA study team. To protect participant 
confidentiality, these signed forms will be kept by WPC in a locked cabinet that only the 
WPC team can access. 
The WPC team will send the research team contact information (name and phone number) 
for potential participants that are interested in the study. To further protect participant 
confidentiality, the WPC team will send a password protected spreadsheet that will be sent 
through our secure mednet email. We will then store the spreadsheet on our secure server. 
WPC will not be informed as to who decides to participate in the study. 
VIII. 
Benefits & Risks  
Benefits: 
There are no potential direct benefits (physical, psychological, social or other) to study 
participants.  
The benefits of the study are gained insight into how the Whole Person Care (WPC) Reentry 
Program influences health and linkages to health care. Additionally, we learn how social 
networks impact health behaviors for transition age youth (TAY). The insight gained form 
this study has the potential to guide the development of other cost-effective interventions to 
help youth stay out of the juvenile system. 

 
16 
 
Risks: 
A breach of confidentiality is one risk of this study. We will minimize this risk by collecting 
information confidentially and adhering to strict protocols to ensure the safety of the data. All 
survey responses will be associated with a study ID number only. In order to mitigate the risk 
of feeling uncomfortable, we will take great care to be respectful of participants. 
Participation is voluntary and participants will be informed of this at study enrollment. 
Participants will also be told that they may drop out of the study at any time and may choose 
not to answer any question that makes them feel uncomfortable. Information about whether 
they choose to participate or not will not be shared with the detention facility, Department of 
Probation, the Health Agency, or anyone else. They will also be told that their decision 
whether or not to participate does not affect their standing with the Court or with Probation. 
All information provided will be kept confidential, including from parents, with the 
exceptions of the information that meets the standard limits to confidentiality (e.g., imminent 
risk of harm to self). Participants will be clearly informed of the limits to confidentiality 
during the consent procedure and immediately before each primary data collection activity. 
Risk/Benefit Analysis: 
Subjects will be told that participation is voluntary. Information about whether they choose to 
participate or not will not be shared with Probation or anyone else. They will be told that they 
may drop out of the study at any time and may choose not to answer any question that makes 
them feel uncomfortable. All information provided will be kept confidential, thus there is 
minimal risk.   
The benefits of the study are gained insight into how the WPC intervention affects health and 
health behaviors. Furthermore, conducting this study will help us examine whether social 
networks are a potential mechanism by measuring whether youth receiving the intervention 
report healthier social networks (lower proportion of peers engaging in risky behaviors and a 
higher number of supportive adults) than control youth. 
IX. 
Data & Safety Monitoring Plan 
To further ensure the safety of all subjects, we (Dr. Barnert and her mentorship team) have 
developed a Data Safety Monitoring Board. We will convene a group of individuals outside 
of our research group to serve as a Safety Board that will provide study oversight. Given the 
nature of our survey and study design, we do not believe we need a full, rigorous and 
independent Data Safety and Monitoring Board. We will plan to include two consultants 
outside of our research group to serve as the Safety Board.  
In addition, this project is part of a career development award for the PI, Dr. Barnert, and she 
will receive the advice of multiple mentors, such as Dr. Mitchell Wong. Dr. Wong will assist 
with identifying the Safety Board members, who we expect will be university faculty. 
X. 
Payments & Cost 
Each participant will receive $50 cash or gift card, based on participant preference, for each 
survey completed ($50 x 3 surveys= $150). If invited to participate in the focus group, 
participants will receive an additional $50.  

 
17 
 
For TAY who complete the baseline survey while detained, a $50 incentive will be provided 
for contacting the research team after their release. Payment for follow-up surveys at 3 and 9 
months post-release will be provided after each survey.  
For TAY exiting the juvenile justice system, participants will receive $50 after each survey 
completed.  
No payment will be provided for the coaches who complete the study. 
Subjects will not incur any financial obligations from participation in the study. 
Amendment 05/27/20: 
For the 19 participants currently enrolled, should they decide to participants in the new study 
procedures, they will receive $25 for each of the 9 monthly qualitative interviews. They will 
also receive an additional $50 for completing the additional follow-up survey.  
Amendment 10/28/20: 
Potential participants, should they decide to participate in the study, will receive $50 for each 
of the four surveys completed: 2 weeks post-release and then two, four, and six months after 
release. During the COVID-19 pandemic, to minimize in-person contact, participants will 
have the option of receiving these incentives through the mail or through payment apps 
(Venmo, Zelle, CashApp, etc.), depending on their preference. Once it is safe to do so, we 
will also allow for in-person delivery options. 
XI. 
HIPAA Authorization 
Amendment 10/28/20: 
Previously, our study team was going to be performing chart abstractions from LA 
Department of Health Services records for those enrolled in the Whole Person Care initiative, 
but we have chosen to not move ahead with this. We will no longer be asking participants to 
sign a HIPAA authorization form. 
XII. 
Recruitment Methods 
For TAY exiting the adult justice system (ages 18-24), the research assistant (RA) will be 
approaching WPC-eligible participants while they are detained. The WPC staff will escort 
the RA to WPC-eligible participants as they make rounds. At this point, the RA will explain 
study and ask eligible participants if they are interested. If interested, consent and surveys 
will be done in a separate room or a location with sufficient privacy.  
For TAY exiting the juvenile justice system (ages 16-19): the RA will receive a list of youth 
exiting the juvenile justice system who have agreed to be contacted about the study. The RA 
will then call youth and their families to explain the study. If interested, verbal assent and 
parental permission (or consent for youth 18 and older) will be obtained over the phone. 
For youth exiting the juvenile justice system, youth will also receive a flyer about the study 
from their field probation officer during their scheduled first visit with the probation office. 
These visits occur within 48 hours of a youths' release. The flyer will inform youth that they 
may contact the research team if they are potentially interested in participation. The research 
team will also contact them. The flyer will also make clear that the youths' and parents' 
decision whether or not to participate in the study will in no way affect their standing with 

 
18 
 
probation and with the court. Probation's role with respect to the study recruitment will only 
be to provide names and phone numbers as well as zip code and age of potential participants 
to the study team. During the consent discussion, we will also request permission to ask 
Probation for updated phone numbers of consented study participants if, during the course of 
the study, we can no longer reach families with the phone numbers provided to us. 
All potential participants will be reminded that their participation is voluntary, and that their 
participation in no way affects their standing with the Los Angeles County Jail, Probation, 
Sheriff's, or Health Departments. 
For potential coach participants, initial contact will be made through the face-to-face meeting 
with the WPC staff. The research team will also receive the names and contact information of 
interested coaches through the WPC staff. We have made prior arrangements and have 
received confirmation with the WPC personnel to share the information of coaches who 
would be interested in participating. A research assistant or PI will call the coaches to 
provide more information on the study. If the coach decides not to participate, any 
information collected from that person will be immediately deleted. 
All potential participants will be reminded that their participation is voluntary.     
Amendment 05/27/20: 
For the addition of monthly qualitative interviews, the research associate will contact 
participants that are currently enrolled and the research associate will explain new procedures 
and ask participants if they are interested. If they are interested, verbal consent, for the 
additional procedures, will be obtained. 
Amendment 10/28/20: 
We will be using remote recruitment and consent procedures during the COVID-19 
pandemic. There will be an in-person option once we are allowed to resume in-person 
procedures. The Whole Person Care team will identify potential participants and will provide 
them with the study authorization form that will give potential participants information about 
the study. If they are interested, they will be required to sign the form allowing the WPC 
team to share their name and contact information with the team. The signature obtained by 
WPC is not meant to enroll participants in the study, but rather it is meant to allow the WPC 
team to share contact information with the UCLA study team. Once the WPC team shares 
this information with the UCLA study team via a password protected spreadsheet that will be 
sent through our secure mednet email, a research assistant will contact interested potential 
participants. If eligible, the RA will review the study with the interested participant and 
obtain verbal consent. The RA will remind the participant of the voluntary nature of the study 
and that participation in no way affects their standing with the Court, the Sheriff’s 
department, or their receipt of WPC. 
XIII. 
Permission & Assent Process for Minors and Informed Consent  
Signed consent and HIPAA authorization will be obtained from participants detained in jail 
and exiting the adult justice system (TAY ages 18-24). For youth exiting the adult justice 
system, consent will be obtained in a quiet room away from others. We will ensure that 
participants do not feel pressure or think that their decision to participate will impact their 
standing with the court, the Sheriff's department or jail staff. 

 
19 
 
A request for youth verbal informed consent/assent and verbal informed parent/legal 
guardian permission is being requested for youth exiting the juvenile justice system. The 
research is minimal risk and does not involve any procedures for which written consent is 
normally required outside the research setting. Permission from one parent/legal guardian is 
sufficient. Given the nature of the study, it is not likely to provoke disagreement between the 
parents/legal guardians about their child’s participation.  
For youth who are 18 years of age or older and exiting the juvenile justice system, verbal 
consent will be conducted. For youth who are under the legal age of 18 years, youth verbal 
assent and parental permission will be obtained. The research team associate receiving verbal 
assent/consent and parent permission will ask youth and parents if the setting is private and 
will ensure participants do not feel pressure or think that their decision to participate will 
impact their standing with the court or with probation. We have provided a summary of the 
permission and assent process below: 
• If youth is 18 years of age or older and exiting the juvenile justice system, only youth 
verbal consent is necessary for youth to participate in the surveys 
• If youth is under 18 years of age and exiting the juvenile justice system, both parent 
permission AND youth assent are necessary for youth to participate in the survey. 
A signed consent from coach participants will be obtained. Only if coaches consent, will 
coaches complete the interview and survey. Consent will be obtained in a private setting.  
Coach consent and youth assent are independent from each other. Whether or not a youth 
participates is independent of whether or not a coach participates. In other words, even if a 
coach does not consent, a youth receiving services from that coach can participate.  
Member(s) of the study staff will provide an oral explanation of the study. Individuals will be 
given a chance to ask questions before making a considered decision about whether or not to 
participate in the study.  
Prospective participants/families will have the opportunity to review the script and may 
discuss the script with others prior to deciding whether or not to participate in the study. For 
verbal consents/permissions/assents conducted over the phone, the research assistant will ask 
the participant if they would like a copy of the consent/permission/assent prior to agreeing to 
participate in a form that is convenient for them (e.g. email, mail, or text message). If the 
participant says “yes,” the research assistant will then make the consent/permission/assent 
available for the participant to review prior to obtaining verbal consent. A follow-up call will 
be scheduled to confirm receipt of consent/permission/assent script and to proceed with 
obtaining verbal consent/permission/assent if the participant wishes to participate in the 
study. For verbal consents/permissions/assents conducted in-person, the participant will have 
a hard-copy of the consent/permission/assent form in their native language (Spanish or 
English) that will be given to the potential participant. All participants will receive a copy of 
their respective consent document with their initial study incentive.  
Amendment 05/27/20: 
For those participants that are currently enrolled in the study, we are requesting verbal 
consent for the addendum consent that includes qualitative interviews and the additional time 
point for the follow-up survey. We will obtain the consent over the phone. Given the 
circumstances surrounding COVID-19, verbal consent will help to minimize physical 

 
20 
 
contact. All participants currently enrolled have recently exited the adult justice system 
(TAY ages 18-24). 
Amendment 10/28/20: 
Going forward, we will be using verbal consent for all adult participants exiting the justice 
system (TAY ages 18-24). We will obtain the consent over the phone. Aside from the study 
authorization form that will be provided to interested participants in jail, member(s) of the 
study staff will provide an oral explanation of the study. Individuals will be given a chance to 
ask questions before making a considered decision about whether or not to participate in the 
study. Given the circumstances surrounding COVID-19, verbal consent will help to minimize 
physical contact. Also, we have chosen to not move ahead with performing chart abstractions 
from LA Department of Health Services records for those enrolled in the Whole Person Care 
initiative, and so we will no longer require participants to sign a HIPAA Authorization form. 
XIV. 
Cultural Considerations  
The consent form and other study documents will be available in the participants' primary 
language. Study personnel (or qualified translators) able to discuss the participation in the 
patients' language will be present for the consent process. Study staff or qualified translators 
will discuss the study in the participants' language. An oral consent process will be used. 
Study personnel (or qualified translators) able to discuss the participation in the participants' 
language will be present for the consent process. 
XV. 
Additional Information 
I would like to address the rigorous permissions process I intend to go through with the 
partnering agency, the LA County Juvenile Court and Probation, before beginning any data 
collection. My plan is as follows: in addition to this institutional review board’s approval for 
the study plan, I will be submitting an "order and petition for research" to the LA juvenile 
court. Per the protocol at the juvenile court, I will send the order for research to the presiding 
judge, as well as to approximately 30 other professionals at Probation and connected to the 
Court. I will also submit Probation's CORI (confidentiality) from for each member of the 
research team. Research team members in contact with the youth will obtain a live scan from 
Probation prior to interacting with youth. I have been in conversation with the appropriate 
contacts of these organizations and have obtained preliminary verbal approval. The Juvenile 
Court will give its final official approval through an approved petition for research and this 
will also serve as the approval of record for Probation. The Juvenile Court has advised me 
that they would only like to see the finalized study plan so I will plan to submit the Petition 
to the Court as soon as this institutional review board has granted approval for the proposed 
activities. An NIH Certificate of Confidentiality has been granted.  
We will not begin study activities (i.e. recruitment/consent) until we obtain full approval 
from the DHS/DPH IRB and until a signed court petition for research is approved. 
I would be glad to make myself available during the IRB's Board meeting to discuss the 
study and answer any questions. I am committed to conducting high quality, ethical research 
that protects the best interest of the youth and their families and that is useful for DHS. My 
goal is to help these highly vulnerable youth and I greatly appreciate your assistance and 
time.  
Thank you for reviewing this application.