Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
Phase: NA
Conditions: Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms, Anxiety, Substance Use, Aggression, Coping Skills, Impulsive Behavior, Housing Problems, Recidivism, Stress, Occupational Stress, Psychological Distress
Sponsor: Florida State University

Title: Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration 
NCT #: NCT04785677 
Date: 4/14/2020 

 
 
Study Summary 
Study Title 
Multisite Randomized Controlled Trial of Comprehensive Trauma 
Informed Reentry Services for Moderate to High Risk Youth 
Releasing From State Prisons 
Study Design 
1:1 Randomized Control Trial 
Primary Objective 
Determine whether the TARGET program helps young men 
released from prison improve their mechanisms of change.  
Secondary 
Objective(s) 
Determine whether the TARGET program helps young men 
released from prison improve their community stability and 
decrease their odds or recidivating.   
Research 
Intervention(s)  
Trauma Affect Regulation: Guide for Education and Therapy 
(TARGET) 
Study Population 
Incarcerated men aged 18-35 who have experienced at least 
one traumatic event in their lifetime. .  
Sample Size 
400 
Study Duration for 
individual 
participants 
Up to 18 Months 
Study Specific 
Abbreviations/ 
Definitions  
Lifetime Traumatic Events (LTE), Trauma Affect 
Regulation: Guide for Education and Therapy (TARGET), 
Department of Corrections (DOC).  
 
 

 
 
1.0 
Objectives* 
1.1 
The purpose of this study is to evaluate the impact of a comprehensive 
trauma-based reentry program for moderate- to high-risk young incarcerated 
males between the ages of 18-35 on post-release outcomes. We will assess 
changes in key mechanisms of change (i.e. mediators) as well as post-release 
outcomes. The key mechanisms of change include: trauma symptoms (PTSD, 
depression, anxiety, and substance abuse), coping, impulsivity, and aggression. 
Post-release outcomes include community stability (i.e., housing and 
employment), and recidivism (i.e., re-arrest and re-incarceration for technical 
violation or new crime; time to re-incarceration).  
1.2 
Research Questions 
• RQ1: Does a comprehensive trauma-based reentry program 
improve key mechanisms of change for moderate- to high-risk 
young incarcerated males?  
• RQ2: Does a comprehensive trauma-based reentry program 
improve community stability for moderate- to high-risk young 
incarcerated males?  
• RQ3: Does a comprehensive trauma-based reentry program 
decrease rates of recidivism for moderate- to high-risk young 
incarcerated males? 
2.0 
Background* 
2.1 
More than 2.2 million young males have some contact with the criminal 
justice system each year; nearly 50% of Black males and 40% of White males 
are arrested for non-traffic related crimes by age 23.1 Close to 200,000 young 
males are currently incarcerated in state and federal prisons across the nation; 
just under 20% of the total state prisoner population are young males at time of 
release.2,3 Younger age at prison intake and release are potent predictors of 
increased risk level; thus, young males are disproportionately identified as 
moderate- or high-risk for recidivism on standardized assessments. After release 
from incarceration, young males have the highest recidivism rate of any age 
group - 76% are rearrested for a new crime within 3 years.4 In a recent 
recidivism analysis, 90% of young men at time of release were re-arrested within 
nine years, with 52% of arrests occurring within the first year.5 
The existence of an inverse, curvilinear relationship between age and 
both arrest and incarceration is treated as an “iconic fact” in the field of 
criminology,6 a fact which suggests that young males essentially “grow up” and 
grow out of committing crime.7,8 However, current recidivism rates among this 
group in particular indicate that some critical facet of young males’ experience is 
missing from existing correctional interventions.9 One potential driver of young 
males’ recidivism may be the unaddressed mental health symptoms and 
substance abuse which result from extremely high prevalence rates of lifetime 
traumatic experiences (LTEs).10-13 According to the American Psychiatric 
Association (2013), LTEs include direct personal experiences of victimization, 
threat or experience of serious injury, threat of death, learning of a serious injury 

 
 
or death occurring to a loved one, or witnessing an event that involves death or 
serious injury/threat to another person in childhood, adolescence, or adulthood.  
Across samples and study design, 62-98% of incarcerated males report at 
least one LTE (prior to incarceration)14-16 compared to 22-47% of men who have 
never experienced incarceration.17,18 Specifically, 58% of incarcerated males 
report physical abuse and 17% report sexual abuse in childhood - 2-3 times the 
estimated prevalence among males in community-based samples.19-21 Further, 
while discussions about LTEs typically center on the experiences of women and 
girls, incarcerated and formerly incarcerated males and females report equally 
high numbers of LTEs, although the nature of LTEs differ between the genders. 
Although incarcerated females report 2.5-4 times the rate of sexual abuse/assault 
as incarcerated males, incarcerated males report witnessing extreme harm to 
others at nearly double the rate as incarcerated females (60% vs. 34.8%).22 
Incarcerated males also report interpersonal nonsexual trauma in adolescence at 
nearly twice the rate as incarcerated females (63.2% vs. 34.8%).22 
Addressing LTEs among incarcerated males is important because more 
than 95% of those who are incarcerated are eventually released23 and trauma 
symptoms and risks for recidivism are correlated. Trauma symptoms include 
increased sensitivity to stress, high levels of negative emotionality, sensation 
seeking (i.e., pursuing risky, stimulating experiences),24,25 aggression, 
impulsivity, dissociation, impaired ability to adequately assess risk, and 
unrealistic expectations of interpersonal relationships.26-28 Rates of posttraumatic 
stress disorder (PTSD) are higher among males with incarceration histories 
(21%) when compared to both males in the general population (4%–5%) and 
male veterans (7%)16,21,29,30; incarcerated males with substance use disorders are 
80% more likely to have experienced two or more LTEs31 including previous 
physical or sexual assault.12 These individuals struggle to remain abstinent from 
drugs and alcohol after release from incarceration12,32,33 and are more likely to be 
re-arrested when compared to their non-victimized peers.10,34,35 
Moreover, trauma symptoms predict violent and nonviolent criminal 
behavior13,36 and formerly incarcerated males who have experienced LTEs are 
significantly more likely to have used violence prior to their incarceration and 
have a higher risk of engaging in violence after release when compared to their 
non-victimized peers.16,37-39 For young incarcerated males, frequent victimization 
is associated with onset of aggression early in life.10 Indeed, incarceration itself 
may exacerbate symptoms associated with untreated LTEs.11,40,41 For 
incarcerated individuals, the number of LTEs is highly correlated with the 
number of incarcerations.13,31,34 Experiences of trauma increase the odds of 
arrest, incarceration, and recidivism, which, in turn, contributes to a higher 
likelihood of additional trauma.42,43 
A substantial body of neuroscientific and psychological research 
identifies why intervening with young offenders is particularly important. The 
adolescent and young adult (ages 10-25) brain is actively developing, growing at 
a rate comparable to that of infancy.44 The young brain is engaged in a highly 
sensitive dual process of pruning and myelination to maximize efficiency and 
integration. This process of neural pathway development is responsive to and 

 
 
dependent on the environment, making young people particularly sensitive to 
LTEs.44,45 The frontal lobe develops through age 25 and controls all executive 
functions including memory, judgment, impulse control, and planning, often 
resulting in impulsivity and risk-taking among young adults. Further, the 
hypothalamic-pituitary-adrenal (HPA) axis, a central part of the stress-response 
system, undergoes significant development during this time; young adults release 
greater amounts of the stress hormone, cortisol, when faced with highly stressful 
challenges and demonstrate higher levels of activity in the amygdala, part of the 
brain responsible for responding to threat.46 Due to the vulnerability of the 
developing brain and stress response systems, witnessing or experiencing 
violence during this time decreases impulse control and retards growth toward 
future orientation which underscores the urgent need to intervene at this 
particularly malleable developmental stage.47 
Gaps in Current Knowledge. Despite incarcerated males’ extremely 
high rates of trauma exposure, research to date has focused nearly exclusively on 
providing trauma treatment to incarcerated females. Only 28 states provide any 
correctional-based trauma treatment81. Of those states, 13 offer trauma treatment 
to men, meaning that 75% of incarcerated males have no access to any 
interventions designed to reduce the impact of LTEs, despite males and females 
reporting nearly equivalent rates of trauma exposure, albeit different types of 
LTEs. Further, the existing evidence supporting trauma-based correctional 
interventions is limited by a lack of randomized controlled trials (RCTs) 
conducted with incarcerated or formerly incarcerated males. Findings from a 
recent meta-analysis48 suggest that there are gender differences in response to 
psychological interventions, with women reporting greater reductions in mental 
health symptom burden when compared to men post-intervention and at follow-
up. This strongly suggests that intervention adaptations and tailored content need 
to be developed to more effectively respond to the trauma treatment needs of 
men. Finally, nearly all trauma-based correctional interventions are delivered 
during custody; only one published study provides any treatment post-release.49 
Therefore, the unique complexities of the reentry period, and the changing needs 
of individuals as they leave incarceration and return to their communities are not 
integrated into existing trauma-based interventions. This gap means that little is 
known about how to implement trauma treatment for young males during 
reentry, when stress is heightened, and they must manage housing instability 
while searching for employment. Interventions that span prison-to-community 
are essential to improving well-being and reducing recidivism among this 
population.  
Although trauma-based interventions are rarely delivered to this 
population, cognitive-behavioral group-based interventions have been 
successfully implemented among samples of racially diverse criminal justice-
involved or at-risk young males.50-52 In a recent systematic review of individual 
and group-based psychological interventions designed to address both 
criminological (crime specific) and psychosocial risks 53, these approaches were 
identified as especially potent for reducing risk and improving well-being among 
the highest-risk, highest-need, hardest-to-engage offenders. Further, robust 

 
 
associations between LTEs and both homelessness and unemployment have been 
noted for a range of high-risk populations. For example, LTEs have been 
significantly associated with increased days of homelessness (β =.18), poorer 
physical health (β =-.23), and drug use (β=.22) among homeless veterans.54 
Additionally, homeless patients with co-occurring mental health and substance 
use disorders were significantly more likely to attend substance abuse treatment 
when compared to those diagnosed only with a substance use disorder.55 
Individuals in a nationally representative sample who experienced childhood 
LTEs were twice as likely to be unemployed (OR=2.0) compared to those with 
no history of LTEs. Unemployment rates were amplified for those who 
experienced childhood physical abuse (OR=2.4) and multiple forms of trauma 
(OR=2.9).56  
Interventions which begin during custody and extend in the community 
after individuals have released from incarceration have shown the strongest 
short- and long-term effects.57-61 Adding a community aftercare component to 
prison-based substance abuse treatment positively impacts recidivism, with 
RCTs demonstrating a 48% reduction in 3-year recidivism for individuals who 
received both in-prison treatment and aftercare (27%) compared to individuals 
who only received in-prison treatment (75%).62 Including post-release services 
extends the protective benefits of in-prison treatment, increasing sobriety and 
decreasing re-arrest. 
We propose a comprehensive trauma-based reentry program for 
moderate- to high-risk young incarcerated males between the ages of 18-35 on 
post-release outcomes. Combining evidence-informed trauma treatment for LTEs 
with a holistic reentry approach focused on community stabilization factors will 
catalyze the reduction of trauma symptoms, impulsivity, and aggression, while 
increasing coping, housing stability, and employment – all factors critical to 
reducing recidivism. Beginning the intervention during custody allows for the 
development of a therapeutic and trusting relationship between group members 
and clinicians, increasing post-release treatment retention. Building on the 
reentry planning work pre-release, post-release groups will focus on the tangible 
needs of housing and employment, while simultaneously addressing the after-
effects of LTEs as they arise in real time during this critical phase of brain 
development and reentry phase transition. Thus, we propose that participation in 
comprehensive trauma-based reentry program will increase housing stability and 
employment, based on the established relationship between trauma symptoms, 
coping, impulsivity, aggression, housing, and employment.53-62 Decreased 
trauma symptoms, impulsivity, and aggression paired with increased coping and 
community stability will reduce recidivism among this sample of moderate- to 
high-risk young males as they leave incarceration and return to their 
communities. 
 
3.0 
Study Endpoints* 
3.1 
Comprehensive trauma-based reentry program group members will 
show improvements in key mechanisms of change compared to TAU 
control group members. 

 
 
3.2 
Comprehensive trauma-based reentry program group members will 
have increased community stability compared to TAU control group 
members. 
3.3 
Hypothesis 3: Comprehensive trauma-based reentry program group 
members will have lower rates of recidivism and those who do recidivate 
will spend more days in the community prior to recidivism compared to 
TAU control group. 
4.0 
Study Intervention 
4.1 
The comprehensive trauma-based reentry program has two primary 
components: a trauma-based intervention paired with community stabilization 
reentry efforts. Consistent with evidence-based reentry approaches,66 the 
proposed intervention will use trauma-trained reentry practitioners to deliver he 
intervention and provide reentry supports including coordinating substance abuse 
treatment, assisting with housing, and providing employment services.  
Trauma-Based Intervention Component. Trauma Affect Regulation: 
Guide for Education and Therapy (TARGET) is a manualized, cognitive-
behavioral, trauma-based group program designed for both young men and 
young women with a history of LTEs who are experiencing trauma symptoms. 
TARGET has an established evidence base.67-71 Up to fourteen TARGET 
sessions will be paired with the specialized reentry supports. Up to four sessions 
will occur prior to release and up to ten sessions will be delivered in the 
community post-release.   
TARGET helps participants understand and manage trauma memories and 
affective dysregulation and provides psychoeducation and skills-based learning 
on how to process and manage trauma-related reactions to stressful life 
situations, including PTSD symptoms, traumatic grief, and shame. The goal of 
TARGET is to increase emotional regulation and coping, helping participants 
gain control of intense emotions and posttraumatic stress reactions while 
simultaneously solving daily stressors and maintaining sobriety. Like other 
present-focused, cognitive-behavioral interventions, TARGET provides a 
systematic approach to processing trauma that does not require memory 
processing or risk re-traumatization. The comprehensive trauma-based reentry 
program pairs trauma-based components with community stabilization reentry 
efforts.  Consistent with evidence-based reentry approaches, the proposed 
intervention will use trauma trained reentry specialists to deliver the intervention 
and provide reentry supports to help improve community stabilization.   
The comprehensive trauma-based intervention component will be 
delivered across up to 19 sessions and each session will simultaneously include a 
focus reentry planning, community stabilization, and trauma treatment. Up to 
four sessions will take place in prison before release and up to 15 sessions will 
take place in the community upon release from prison. Sessions delivered during 
custody will provide psychoeducational information on trauma and reentry, and 
facilitate reentry planning with a focus on community stabilization and service 
identification and access. Sessions in the community will be delivered post-
release and will focus on emotion awareness and regulation, recognizing and 

 
 
positively responding to their triggers, evaluating their thoughts, and identifying 
positive emotions. Post-release sessions will also enable the participants to 
develop healthier coping skills, manage their mental health symptoms, 
impulsivity, and aggression, and decrease substance abuse.  
 
5.0 
Procedures Involved* 
6.1 The proposed 5-year study is a two-armed 1:1 Randomized Controlled Trial 
(RCT) implementing and evaluating the effectiveness of a comprehensive 
trauma-based reentry program for young men releasing from prison to the 
community evaluated as moderate- to high- risk for recidivism. A total of 400 
18-35 year old males releasing to one of the four participating urban and rural 
counties in Florida (Columbia, Duval, Leon, and Suwanee) will be randomly 
assigned to participate in the comprehensive trauma-based reentry program or 
a treatment-as-usual (TAU) control group. Participants in the comprehensive 
trauma-based reentry program will participate in up to four group sessions 
while incarcerated and up to15 group sessions in the community after release.  
The effectiveness of the comprehensive trauma-based reentry program for 18-
35 year old males will be evaluated on the following constructs: key 
mechanisms of change, community stability, and recidivism. Participants 
assigned to the treatment-as-usual control group will remain eligible to 
participate in all reentry services they normally would have received.  
 
The purpose of this study is to evaluate the impact of a comprehensive 
trauma-based reentry program for moderate- to high-risk young incarcerated 
males between the ages of 18-35 on post-release outcomes. We will assess 
changes in key mechanisms of change (i.e. mediators) as well as post-release 
outcomes. The key mechanisms of change include: trauma symptoms (PTSD, 
depression, anxiety, and substance abuse), coping, impulsivity, and 
aggression. Post-release outcomes include community stability (i.e., housing 
and employment), and recidivism (i.e., re-arrest and re-incarceration for 
technical violation or new crime; time to re-incarceration). 
5.2 Research team members are trained interventionists in order to assess if there 
are adverse behaviors or thoughts during service delivery (treatment group) 
and during data collection interviews (all participants). All interviews are 
conducting one-on-one so the research team member can assess for adverse 
reaction to the data collection or treatment delivery 
5.3 Research team members have experience working with people with trauma 
histories.  This is important so they can successfully assess if there are 
adverse behaviors or thoughts during service delivery (treatment group) and 
during data collection interviews (all participants). All interviews are 
conducting one-on-one so the research team member can assess for adverse 
reaction to the data collection or treatment delivery. 
6.4 Data will be collected from participants during one-on-one 
interviews. Interviews will occur in a private space, where the 
conversation between the team member and individual cannot be 

 
 
heard. Data will be recorded in RedCap computer software. Potential 
participants will complete 12 -count trauma checklist as a screener for 
assessing for presence of at least one LTE. Eligible participants will 
plan to release to one of our four Florida counties. Participants will be 
consented using a Florida State University IRB consent form. If the 
individual meets screening criteria and consents into the study, the 
research team member will complete the baseline interview. 
All consented participants (treatment and control) will complete a 
series of interviews. Baseline interviews will occur immediately after 
consent and occur in prisons. Follow-up interviews will be conducted 
in the community and timepoints include (1) after the conclusion of 
the program period, (2) three months after the conclusion of the 
program period, and (3) nine months after the conclusion of the 
program period.  
6.5 Measures were selected based on the quality of established 
psychometric evidence and use with criminal justice-involved or other 
at-risk populations.  
• Risk Assessment. Spectrum is the assessment tool used by FDC that 
identifies risk factors for criminal behavior. Scores on Spectrum range 1-
5. The assessment is given to individuals at intake, periodically 
throughout incarceration and then again under a year before they release 
and measures an individual’s risk to recidivate. 
• Trauma screener. A dichotomous Yes/No measure of 12 LTEs s from 
the Trauma Assessment for Adults serves as the trauma screening tool. 
Participants are identified as eligible if they have experienced at least 
one LTE.  
• Demographics. Age, race/ethnicity, marital status, level of education at 
release, age at first offense, number of prior incarcerations, most serious 
offense, and current sentence length will be collected from FDC 
administrative databases. 
• Trauma. The 24-item Trauma History Questionnaire (THQ)72 was 
designed to assess LTEs among general, community, and clinical 
populations. Each item examines a specific traumatic experience under 
the categories of interpersonal violence, accidents and disasters, serious 
illness, traumatic loss, and criminal victimization. Participants indicate 
whether they experienced the event, and if so, they provide age at time 
of exposure and a brief description. The THQ operationalizes Diagnostic 
and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria 
for LTEs. The THQ is a reliable measure of trauma exposure (3-month 
test-retest coefficients=.51-.91) and has strong convergent validity to 
other measures (k=.61-1.00).   
• PTSD. The 20-item PTSD Checklist for DSM-5 (PCL-5)73 will be used 
to assess PTSD symptoms at all interview timepoints. All items are 
scored on a 5-point Likert scale with 0= “not at all” and 4= “extremely”. 
Scores above 33 indicate current incidence of PTSD. The PCL-5 has 

 
 
strong reliability (α=.94), test-retest correlations (r=.82), and has strong 
convergent validity and discriminant validity. 
• Depression. The 11-item major depressive disorder subscale of the MINI 
International Neuropsychiatric Interview (MINI)74 assesses current 
incidence of depression at all interview timepoints. Items are rated on a 
dichotomous Yes/No scale and follow DSM-5 psychiatric guidelines. 
The MINI has strong interrater reliability and the kappa value for the 
major depressive disorder construct was adequate (k=.72). 
• Anxiety. The 7-item anxiety subscale of the MINI assesses current 
anxiety disorders at all interview timepoints. Items are rated on a 
dichotomous Yes/No scale and follow psychiatric guidelines of the 
DSM-5. The MINI has strong interrater reliability and kappa values for 
anxiety disorder constructs were adequate (k=.69-.84). 
• Substance Use Disorder. The 9-item substance use disorder subscale of 
the MINI assesses current incidence of substance use disorders at all 
interview timepoints. Items are rated on a dichotomous Yes/No scale 
and follow psychiatric guidelines of the DSM-5. The MINI has strong 
interrater reliability and the kappa value for the substance use disorder 
construct was adequate (k=.74). 
• Coping. The 26-item Coping Self-Efficacy Scale75 assesses self-efficacy 
and confidence in coping with stress at all interview timepoints. The C-
SES is reliable and valid (α=.80-.91). 
• Impulsivity. The 30-item Barratt Impulsivity Scale (BIS)76 assesses 
general impulsiveness at all interview timepoints on six first-order 
factors (attention, motor, self-control, cognitive complexity, 
perseverance, and cognitive instability impulsiveness) and three second-
order factors (attentional, motor, and non-planning impulsiveness). The 
BIS was validated among community, clinical, and correctional samples 
(α=.79-.83).  
• Aggression. The 12-item Brief Aggression Questionnaire (BAQ)77 
evaluates physical aggression, verbal aggression, anger, and hostility at 
all interview timepoints. The BAQ has stable test-retest reliability and 
convergent validity with behavioral aggression measures.  
• Housing. A 7-item housing measure will assess housing stability at all 
post-release timepoints. Sample items include, “Have you had to 
“double up” with friends or relatives?”, “Do you consider yourself 
homeless?”, and “Where are you living or staying now?” 
• Employment. A 10-item employment measure assesses employment at 
all interview timepoints. During the initial in-prison interview, the 
participant will be asked to think about their employment six months 
prior to their current incarceration. In all post-release interviews, the 
participant will be asked to reflect on their employment in the previous 
three months. Sample items include, “What was your work situation 
right before your current incarceration/over the past 3 months]?” and 
“How long have you been at your current employment?” 

 
 
• Recidivism. Recidivism data on arrests in Florida, incarceration in a 
Florida state prison, the number of days to arrest or incarceration, and 
the reason for incarceration (i.e., commission of new crime or violation 
of the terms of release) will be collected from FDC and Florida 
Department of Law Enforcement databases annually for three years. 
 
6.0 
Data and Specimen Banking* 
6.1 Collected data is stored in REDCap, and research team members and 
data analysts have access to the system. Data is protected and HIPPA 
compliant.  Data collected is the interview assessment data using the 
tools listed in 6.4 for the initial interview and the 3 follow-up 
interviews.  
7.0 
Sharing of Results with Subjects* 
N/A 
 
8.0 
Study Timelines* 
 
8.1 Describe: Individuals will be recruited approximately four to six 
months prior to release and then we will remain in contact with them 
to collect primary data from them for 9 months after the conclusion 
of the intervention. Thus, participants can end up being engaged with 
the study for a maximum amount of 18 months. 
Research Activities 
Related Timelines 
Recruitment of Study Participants: 
May 2020-October 2021 
Programming inside facilities: 
June 2020-December 2021 
Community Programming: 
September 2020 -March 2022 
TI (Completion of programming period): 
November 2020-March 2022 
T2 (3 Months post completion of program period) 
February 2021-June 2022 
T3 (9months post completion of program) 
August 2021-Ducember 2022 
 
8.2 Based on a recruitment goal of 400 and the number of staff and 
students that will be used to recruit study participants, it is 
anticipated that it will take eighteen months to enroll all study 
subjects into the study. 
9.0 
Subject Population* 
Commented [A1]: Eligibility : Age, Risk Factor Identification 
(spectrum?), Screening for Lifetime Traumatic Experiences, 
Conversational English, Cognitive Consent, Release to Leon or 
Duval 
 
Random Number generator (randomization) 

 
 
9.1 Participant inclusion requirements include: (1) male; (2) age 18-35; 
(3) identified as having risk for recidivism; (4) screened as 
experiencing at least one LTE; (4) releasing from incarceration to 
one of our four study counties within six months; (5) conversational 
English; and (6) being able to cognitively consent into study 
participation. 
9.2 Participants may be excluded if: they  (1) identify as women; (2) 
younger than 18 or older than 35; (3) no demonstrated any risk; (4) 
not cognitively able to understand what it entails to be a research 
participant. 
10.0 Vulnerable Populations* 
10.1 The research team has reviewed the checklist relating to studies involving 
incarcerated individuals and have designed the study to be in consideration 
of these guidelines for the population.   
11.0 Local Number of Subjects 
11.1 400 individuals will be recruited into the study to participate. 
Participants will be returning to the following four county area: 
Leon, Columbia, Duval, and Suwanee.  
12.0 Recruitment Methods 
12.1 In order to enroll participants into the study, the research team will 
obtain regular lists of prospective participants from the Florida 
department of corrections (FDC) in each state. The list includes the 
name, age, sentencing county, prison location, scheduled release 
date, risk score, and offense history so that research team members 
can randomly identify prospective study participants. Then, the 
research team member emailed the primary contact person at each 
prison site the list of prospective participants' names and DOC ID 
numbers using a password protected and encrypted Excel database to 
schedule individual information and screening sessions. 
The primary contact person at each prison site nor any other 
correctional official has a role in selecting the prospective 
participants that will be eligible for an information and screening 
session. Researchers schedule days to meet with prospective 
participants at the prisons. On those days, researchers will arrive at 
the prison and will meet with corrections officials to confirm with 
the official the names of those participants that the researchers met 
with to tell them about the study. Every member of the research team 
will be trained in the Prison Rape Elimination Act (PREA).  
The day of the visit for recruitment, the correctional official can say 
that the visitor is from the Florida State University, but otherwise 
will not tell the prisoner that the visitor is there to see him/her about 
a research study. The prisoner can refuse to meet with the visitor. 
We do not want the correctional officer talking to the prisoner about 

 
 
the study for several reasons: a) reduce potential for coercion; b) 
because it is not feasible to train all correctional officers in the prison 
on research protocol; and c) to protect confidentiality of the 
prospective participant. 
Once the prisoner arrives to the visit in a private meeting room, the 
researcher will tell the prisoner about the study. The private room is 
one in which correctional officers may be able to see into the room 
for security purposes, but they cannot hear the content of the 
meeting. First, the researcher will confirm whether the returning 
prisoner intends to live in one of the designated study counties. 
Those individuals who do not intend to live in a study county will be 
thanked for their time and told they are not eligible for study 
participation.  
The researcher will conduct consent procedures. The researcher will 
read aloud the consent form and allow for participants to have time 
to read the consent form on their own. The researcher will assure 
participants that their supervision will not be affected by their choice 
to participate or not participate in the study. The participants will 
also be told they can discontinue the study at any point or refuse to 
answer any questions without consequence. The benefits and risks of 
the study will be reviewed as will the expectations and limitations to 
breaches of confidentiality. Participants will be provided with two 
copies of the consent form – one for the participant to sign, either 
esign or paper signature, and return to the researcher and the other 
for the participant to keep. However, the participant is not obligated 
to keep the consent form. The participant is offered a copy to keep so 
they will have information about how to contact the research team 
with further questions and the IRB contact information. If participant 
chooses not to keep the consent form, they will be told that they can 
always request a consent form after release if they so choose. No 
aspect of the study will proceed until the consent process is 
completed. A researcher will inform participants that if they decide 
not to be in this study, or stop participating at any time, they will not 
be penalized or lose any benefits for which they otherwise qualify. A 
researcher will also inform participants that their sentence, program 
participation, employment opportunities, or any other aspects of their 
supervision by the DOC will not be affected by their choice to 
participate. Participants will be informed that their responses will be 
kept confidential to the fullest extent of the law. If a participant 
discloses they are the perpetrator or victim of sexual assault within 
the prison milieu, the incident will be addressed in accordance with 
PREA guidelines. 
12.2 Participants receive $30.00 for completing each of the three post-
release interviews. The three follow-up interview timepoints are: (1) 
after the conclusion of the program period (post-test), (2) three 
Commented [A2]: Add e-signature  

 
 
months after the conclusion of the program period, and (3) nine 
months after the conclusion of the program period. Research 
participants will not get money for completing the baseline 
measurement packet while incarcerated.  
13.0 Withdrawal of Subjects* 
13.1 The person in charge of the research study or the sponsor can 
remove you from the research study without your approval. Possible 
reasons for removal include: Will release from prison after 
recruitment for study participation ends, lost eligibility to be a 
research participant; or interfered with ability to complete study 
protocol. 
13.2 If a subject is to be withdrawn, an IRB approved withdrawal letter 
with the reason for withdrawal is sent to the participant. Subject 
withdrawals are tracked and reported to the IRB.  
13.3 If a subject is withdrawn from the study by the research team for one 
of the reasons listed here, the research team will use information 
collected during the interviews to help determine whether the 
TARGET model is effective in helping people released from prison. 
Participants are informed of this protocol during the informed 
consent process.  
14.0 Risks to Subjects* 
14.1 Participants may become emotionally distressed when thinking and 
talking about the following: their history of participation in crime; 
history of incarceration; social relationships; services history; 
behavioral health problems; education attainment; employment 
status; or transition back to the community. Probability of these risks 
are low. Our staff is trained to work with participants if they feel 
emotionally distressed during interviews or service delivery.  
All legally available protections will be in place to protect 
confidentiality of data shared. However, if participants disclose an 
intent to harm themselves or someone else, this information will be 
reported to the proper authorities. This procedure will be disclosed in 
the consent form. However, if people do disclose these intents, it 
could result in legal or social risks. The same procedure follows if a 
participant is found to need minor medical or psychological referral, 
the participant will be encouraged to share this information with 
research team members. If the medical or psychological need 
appears to place the participant at risk of harming himself or others, 
the researcher will immediately share the medical or psychological 
risk information with the participant’s practitioners. The consent 
form will describe this procedure. If the medical or psychological 
need appears to place the participant at risk of harming himself or 

 
 
others, the researcher will immediately contact local authorities 
about the concern. The consent form will describe this procedure.  
Participants may feel distressed by the random assignment process 
and about the group to which they are randomly assigned. The 
consent form clearly describes the randomization process and 
chances of being in the control group, thus the probability of 
emotional distress is low. 
A risk of participation in this study is a breach of confidentiality 
through the accidental disclosure of the participants’ private, 
identifiable information. Probability of this is low due to use of 
secure data management systems and constant training with Prison 
and Research staff on the importance of confidentiality. All 
interviews are conducted in confidential settings. To minimize risk 
of accidental disclosure of identifiable private information, a 
meaningless code number will be established for all participants 
immediately following consent. That code number will be attached 
to all interview tools rather than identifying information. A separate 
document linking identifying information and meaningless ID 
numbers will be stored apart from consent forms in a locked cabinet 
in the research team office. 
15.0 Potential Benefits to Subjects* 
15.1 Possible benefits from the study include discussing the relationships 
between previous experiences, mental health issues, and criminal 
offending. The participants may also benefit by thinking about the 
influence of violence and victimization on your patterns of on 
patterns of offending, perhaps providing space for you to make 
difference choices after release. All Participants (Control and 
Treatment groups) 
These participants may benefit from DOC services that include 
educational and vocational preparation, transition preparedness 
programming, 12 step groups, behavioral health services, religious 
programming, and case management.  
16.0 Data Management* and Confidentiality 
16.1 Data analysis will include statistical techniques such as t-tests, 
correlations, chi-square testing, ANOVA, survival analysis, 
structural equation modeling, and multilevel modeling.  
16.2 To minimize risk of accidental disclosure of identifiable private information, 
a meaningless code number will be established for all participants 
immediately following consent. That code number will be attached to all 
interview tools rather than identifying information. A separate document 
linking identifying information and meaningless ID numbers will be stored 
apart from consent forms in a locked cabinet in the research team office. 

 
 
16.3 Research team members are all trained on using REDCap to store, 
encrypt, and protect the data.  REDCap servers are housed in a local 
data center at Florida State University and all web-based information 
transmission is encrypted. REDCap was developed specifically 
around HIPPA-Security guidelines. All identifiable information is 
replaced with a meaningless code number for the sake of 
confidentiality.  
The researchers will obtain the participants department of 
corrections’ identification nm 
16.4 Data collectors all have tablets with REDCap. They collect 
information from the participants on their tablets using REDCap, 
which is housed in a local data center at FSU.  We will maintain all 
study records, including signed and dated consent documents for six 
years after completion of the study.  
16.5  Data will be stored in REDCap for six years after completion of the 
study.  Research team members have access to the data and are 
responsible for receipt or transmission of the data.. 
17.0 Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
N/A There are minimal risks to subjects in this research project 
 
18.0 Provisions to Protect the Privacy Interests of Subjects 
18.1 Research participants are not ever required to meet with somebody 
whom they do not want to interact. If the participant would like a 
different interviewer, or a different person to facilitate the TARGET 
sessions if they are in the treatment group, then the research team 
will grant them that wish if possible.  The participant will be 
informed at consent, and reminded throughout the study, that they 
can choose to stop any interview or intervention session at any time 
without any consequences or repercussions whatsoever. The 
participant has the option to not answer any questions that they find 
too personal and do not want to share with the interviewer. This 
information is all discussed with the participant during the informed 
consent process at the beginning of the study. 
18.2 Research team members are trained in interviewing skills, including 
how to talk with the research participant in an empathic manner that 
helps put them at ease, which is particularly important considering 
the sensitive nature of some of the questions. Regarding the 
TARGET program for those in the treatment groups: all of the 
interventionist are trained counselors who are trained in working 
clinically with participants and have experience talking with our 
research participants in an empathic manner.   

 
 
18.3  The only information the research team will access that does not 
come directly from the participants are the administrative data 
collected from department of corrections databases.  This includes 
the following:  
• 
race/ethnicity 
• 
release dates; 
• 
type and length of supervision being released into; 
• 
if you are on court mandated treatment during incarceration or 
post-release, and what type of treatment is required; 
• 
custody levels at initial assignment and release; 
• 
prison identification number; 
• 
date of birth; 
• 
both community and institutional (at time of entry into facility and 
final) risk scores, and which assessment tool is used; 
• 
treatment and program participation; 
• 
Protected Health Information from the Department of Corrections 
database; 
• 
criminal history, including length of sentence, number of priors, 
age of first arrest, age at present offense, list of convictions, and 
what you are serving your current sentence on; 
• 
recidivism data, including dates and number of: rearrests resulting 
in a 48 hour stay, jail time, incarceration for a new conviction, re-
incarceration from state prison for a new offense or technical 
violation, residential sanction facility; 
• 
technical violations, including what the violation was and the result 
of violation; 
• 
sanctions, including type, number received and reason for sanction; 
• 
education level at admission and at release; 
• 
employment status on admission and for those on parole; 
• 
home plan upon release and housing status for those already 
released; 
• 
program treatment referral or receipt by parole, including your 
need, services received and services completed 
 
19.0 Compensation for Research-Related Injury 
19.1 N/A. 
20.0 Economic Burden to Subjects 
20.1 The only potential economic burdens include travel time and/or 
expense related to transportation to research site.  However, the 
research team is mobile and usually conducts interviews in the 
participants’ home community.   
21.0 Consent Process 
Commented [A3]: Are these all applicable? 

 
 
21.1 The consent process takes place in prison for eligible participants 
released to our participating counties in the study window. Research 
team members facilitate the consent process. Consent is obtained 
electronically with the tablets that store REDCap.  The consents are 
discussed and obtained in person at the prison after the research team 
member introduces the project to the potential participant and 
explains why they have been selected. Potential research participants 
are given as much time as they need to make a decision on whether 
to participate in the research. 
The research team is following the “SOP: Informed Consent Process 
for Research (HRP-090) for the consent process.  
22.0 Process to Document Consent in Writing 
22.1 The consent process takes place in prison for eligible participants released 
to our participating counties in the study window. Research team members 
facilitate the consent process. Consent is obtained electronically with the 
tablets that store REDCap.  The consents are discussed and obtained in 
person at the prison after the research team member introduces the project 
to the potential participant and explains why they have been selected. 
Potential research participants are given as much time as they need to make 
a decision on whether to participate in the research. 
 
The research team is following the “SOP: Informed Consent Process for 
Research (HRP-090) for the consent process.  
 
23.0 Setting 
23.1 Below are the participating prisons in the research study. Please go 
to the Local Research Locations in RAMP to see more details about 
each facility. 
o Apalachee Correctional Institution,  
o Baker Correctional Institution,  
o Bay Correctional Facility,  
o Blackwater Correctional Facility,  
o Columbia Correctional Institution,  
o Florida State Prison,  
o Gadsden Reentry Center, 
o Graceville Correctional Facility,  
o Holmes Correctional Institution,  
o Jackson Correctional Institution,  
o Lake City Correctional Facility,  
o Liberty Correctional Institution,  
o Northwest Florida Reception Center,  
o Reception and Medical Center,  
o Taylor Correctional Institution,  

 
 
o Wakulla Correctional Institution 
o Cross City Correctional Institution 
o Lake Correctional Institution  
 
24.0 Resources Available 
24.1 Research team members will schedule in advance with the primary 
contact person the days to go to the prison for recruitment and baseline 
data collection.  Each interview will last for between 1.5 and 2 hours and 
will take place in rooms where the conversation can be confidential.  
24.2 Participants will be referred to mental health staff in the prisons if 
the research team member assesses they need counseling as a result of 
answering the questions on the interview packet. Specifically, the 
research team member will make a referral through the classification 
officer and/or primary contact person at the prison. Additionally, the 
informed consent contains resources for the participant if they are feeling 
emotional distress or need immediate assistance.