Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families
Phase: NA
Conditions: Parenting, Development, Child, Behavior
Sponsor: University of Wisconsin, Madison

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pathways for Parents After Incarceration Feasibility Study 
 
 
 
 
Principal Investigator: Pajarita Charles, PhD 
 
NCT04525703 
 
4R00HD081273-03 
 
Eunice Kennedy Shriver National Institute of  
Child Health and Human Development (NICHD) 
 
 
March 31, 2023 
 
 
 
 
 
 
 
 
 
 
 
 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
 
1.0 
STUDY SUMMARY 
 Synopsis 
 
Full Title 
Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families 
Short Title 
Pathways for Parents After Incarceration Feasibility Study 
Protocol Number 
MRR IRB 2020-0144 
ClinicalTrials.gov 
Identifier & 
Summary 
NCT04525703 
The purpose of this study is to learn how to better support fathers and their families after 
incarceration. It will test an intervention that promotes healthy development for children of 
previously incarcerated fathers and the caregivers of their children for empirical promise 
through a pilot feasibility trial. About 15 families (15 fathers, 15 caregivers, and 15-20 
children, totaling 45-50 participants) will be in the study. 
Number of 
Site(s) 
UW Madison 
Phase 
NA 
Main Inclusion 
Criteria 
Fathers: 
• 
being able to speak and read English 
• 
having at least one child between the ages of 3 and 17-years-old 
• 
having been released from incarceration within the last 5 years (from county jail or 
state/federal prison) 
• 
play a parenting role in at least some way (e.g., residence, contact, phone, etc.) 
 
Caregivers: 
• 
able to speak and read English 
• 
at least 18-years-old 
Main Exclusion 
Criteria 
• 
have been convicted of a crime against any of his children 
• 
are prevented from having contact with their child 
Objective(s) 
The aims of the pilot are to demonstrate:  
• 
a) client acceptance of the treatment (e.g., retention) 
• 
b) ability to recruit sufficient numbers of participants 
• 
c) feasibility of delivery with the clients and therapists in the designated treatment settings 
Endpoints 
Key outcome measures will assess father involvement, extended family relations, and child 
outcomes in addition to self-report criminal behavior, substance use, and recidivism for the 
fathers. 
Study Design 
Feasibility of a behavioral intervention  
FDA Regulatory 
Overview 
NA 
Study 
Intervention 
The Pathways for Parents after Incarceration program uses eight key lessons, including 
topics on effective listening, speaking, and problem-solving skills, lessons on emotion 
regulation, and issues surrounding family engagement. The program (both classroom and 
therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks. 
Total Number of 
Subjects 
47 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
Study Population Children of previously incarcerated fathers and the caregivers of their children. 
Statistical 
Methodology 
Descriptive statistics (univariate analyses) and inferential statistics to assess differences 
between pre and post-test variables (bivariate analyses) 
Estimated 
Subject Duration 
The duration of the study for each subject is approximately 21 weeks including follow-up 
survey. 
Estimated 
Enrollment 
Period & Study 
Duration 
Study enrollment and follow-up will occur over 19 months with the total expected duration of 
the trial to be 19 months. 
 
 
 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 Schematic of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete 3-month Follow-up Interview: study survey and standardized measures. 
Complete post-intervention interview: study survey and standardized measures.  
Complete baseline interview: study survey and standardized measures. 
Communicate start date of group intervention. 
Total N: 50   
Screen potential participants by inclusion and exclusion criteria. 
Administer study intervention Sessions 1 – 8 (one per week). 
Conduct informed consent process.   
Administer study intervention makeup sessions if needed. 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
2.0 
INTRODUCTION 
 Purpose 
The purpose of the overall study, Promoting Healthy Development among Children of Fathers with 
Antisocial Behavior, is to build and test a preventive family-focused intervention in a feasibility study that 
promotes healthy development for children of previously incarcerated fathers and their children. The study 
has three specific aims, two of which have already been completed. The first was to conduct secondary 
data analyses to explore a series of questions that explored topics including fathers' history of antisocial 
behavior and criminality, children's psycho-social and behavioral health outcomes, father engagement and 
parenting behavior, maternal parenting practices, quality of parental relationship, and extended family 
involvement. The second aim included conducting semi-structured interviews with fathers, mothers, and 
relatives to improve understanding of the barriers to father engagement and challenges that families face 
as fathers return to the community following incarceration. 
 
To that end, this protocol situates itself within the third and final aim, that of specifying treatment 
procedures (e.g., develop manuals, select measures, specify therapist training and adherence procedures) 
and establishing feasibility of the intervention (e.g., recruitment, enrollment, fidelity, adherence, retention, 
and safety). Specifically, this protocol is in regard to the feasibility of the intervention. The purpose is to test 
the intervention for empirical promise through a pilot feasibility trial. The aims of the pilot are to 
demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of 
participants, and c) feasibility of delivery with the clients and therapists in the designated treatment 
settings. 
 
The family intervention is based in a family systems model that includes all members of the family. Multiple 
family groups are used because previous research has found they are efficient forms of service delivery, 
build social support among participants, and improve parent-child interactions. Feasibility of the pilot must 
include all participants anticipated in the program model to test strategies, logistics, and measures. 
Drawing from the framework of dissemination and implementation science, another central purpose of the 
pilot is to refine the operational methods that will facilitate translation and implementation in the future 
should the intervention be found efficacious and effective. This pilot will answer questions that are pertinent 
to intervention development, as well as the success of dissemination and implementation in the future. 
 Name and Description of the Study Intervention 
 
Pathways for Parents after Incarceration is a community-based program that seeks to equip fathers with 
the skills both for positive father engagement and reentry success. It uses a manualized curriculum that is 
adapted from a prison-based program, Parenting Inside Out (PIO). PIO is an evidence-based, cognitive-
behavioral parent management skills training program created for incarcerated parents through a six-year 
collaboration of scientists, policy makers, practitioners, and instructional designers. Both the information in 
the program and the way that information is presented were informed by knowledge derived from research 
and practice. Extracted from the full 90-hour version, the Pathways for Parents after Incarceration program 
uses eight key lessons from one of the original versions (PIO-48) that have been identified by the research 
team and those with lived experience as being most beneficial to them. These include topics on effective 
listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding 
family engagement. The course is led by 2 parent coaches who will be hired and formally trained to deliver 
PIO by the PIO parent organization, The Pathfinder Network. The classroom-based PIO sessions will be 
delivered over 8 weeks in two- to two-and-a-half hour sessions. These classes will be held entirely virtually 
using a web-based video software. All participants will utilize computers with cameras and audio in order to 
join the class remotely. At no time will audio or video be recorded. All classroom components, including 
small group break outs and activities, will be done remotely. 
 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
In addition to the classroom component that PIO provides, the program will offer a therapeutic component. 
These sessions will also be done virtually. Weekly, those receiving services from Pathways for Parents 
after Incarceration will be invited to take part in a remote peer support group-style group session led by a 
provider within the community, Anesis Family Therapy. This component of the program is rooted in 
systems therapy and uses narrative therapy, trauma focused cognitive therapy, and motivational 
interviewing techniques. This aspect promotes fathers’ and caregivers' ability to identify their values and 
skills so they can effectively confront the challenges (both instrumental and relational) that they face during 
their reentry period and as family members working to support the fathers. These sessions will run for 45-
60 minutes following the classroom portion (PIO). 
 
The program (both classroom and therapeutic peer support) will be offered weekly in virtual, remote format 
on for 8 continuous weeks (the 9th week will be a class graduation/celebration). Any participant that does 
not have access to a computer will be loaned laptops or tablets and internet hotspots. The structure of the 
sessions are as follows: 
 
5:00pm - virtual classroom opens and PIO course activities begin 
7:00pm - PIO class concludes and 30 minute break begins 
7:30pm - therapeutic peer support 
8:30pm - wrap up 
 
These sessions will provide gift card or cash incentives for attending and completing class material. Food 
will be delivered to their home in lieu of providing food in person during group meetings as was originally 
planned before COVID-19. 
 
The third and final piece of the program includes the opportunity for fathers and their families to partake in 
family engagement activities. Prior research pointed program development to the need to support fathers in 
their ability to spend time with their children engaged in prosocial activities. Pathways for Parents after 
Incarceration will offer monthly activities to program participants and their families which will provide 
families the opportunity to enhance their interactions with each other and other families in a safe way. This 
may include kits that the research team drops off for families centered around art, literacy, or games. It may 
also include virtual gatherings or outings in socially distanced venues. All decisions related to activities will 
be guided entirely by recommendations of Madison and Dane County Public Health Department in 
Wisconsin. The plan is to develop all virtual activities and then only if other formats are allowed, would we 
do something else. 
 
3.0 
STUDY OBJECTIVES AND ENDPOINTS 
The aims of the pilot feasibility trial are to demonstrate:  
a) client acceptance of the treatment (e.g., retention) 
b) ability to recruit sufficient numbers of participants 
c) feasibility of delivery with the clients and therapists in the designated treatment settings 
 
Specified measures will be collected at various times (e.g., client experience and satisfaction at post-
intervention time points; outcome measures at pre- and post-intervention time points). Key outcome 
measures will assess father involvement, extended family relations, and child outcomes in addition to self-
report criminal behavior, substance use, and recidivism for the fathers. Waves of data collection will occur: 
1) prior to beginning the program, 2) immediately following the program, and 3) 3-months after completing 
the program. Data collection will be done with the father, caregiver, and child. This will be done virtually 
either by phone with research team members reading prompts to participants or by video conferencing 
where team members can virtually share screens and walk through documents together, or virtually with 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
research team members reading prompts and writing down answers. If not possible, it would take place in 
a private setting (ideally outdoors) where researchers and participants can be safely socially distanced. 
 
4.0 
STUDY DESIGN 
 General Design  
The purpose of this pilot feasibility trial is to specify treatment procedures and establish feasibility of an 
intervention with the goal of identifying elements required for a randomized control efficacy and 
effectiveness trial in the future. The focus is on intervention procedures and assessment of feasibility as 
outlined in the Stage 1a and Stage 1b steps of new treatment procedures. No randomization of participants 
occurs.  The focus is on demonstrating 1) client acceptance, 2) ability to recruit, and 3) feasibility of 
delivery. Data are collected from participating fathers, caregivers, and children. 
 
 
 End of Study Definition 
The end of the study is defined as the date of the final visit completed by the last remaining subject in the 
study. This may be either the date of the last visit or the date of the final visit completed before that 
subject’s participation ends (e.g., withdrawal, lost to follow-up, expiration). 
5.0 
SUBJECT SELECTION 
 Inclusion & Exclusion Criteria  
 
Inclusion Criteria - Fathers 
1. being able to speak and read English 
2. having at least one child between the ages of 3 and 17-years-old 
3. having been released from incarceration within the last 5 years (from county jail or state/federal 
prison) 
4. play a parenting role in at least some way (e.g., residence, contact, phone, etc.) 
5. being able to speak and read English 
6. having at least one child between the ages of 3 and 17-years-old 
 
Inclusion Criteria – Caregivers 
1. able to speak and read English 
2. at least 18-years-old 
 
Exclusion Criteria 
1. have been convicted of a crime against any of his children 
2. are prevented from having contact with their child 
 Vulnerable Populations 
It is important to document and mitigate the effects of incarceration on individuals and families, and thus we 
are focusing our intervention on previously incarcerated parents and their children. We are also interested 
in decreasing recidivism, which is a significant problem in the United States. Children with incarcerated 
parents are at risk for a host of problems and one of the hypothesized mechanisms is related to positive 
father involvement, improved parenting practices, and broader familial support. 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
The study seeks to enroll fathers previously incarcerated in jail or state/federal prison. This is a group of 
individuals who face significant barriers to being successful and engaged with their family after prison or 
jail, largely because of racially discriminatory practices used in society that results in disproportionate 
numbers of minorities incarcerated in prison and jail. Research to promote positive father involvement is 
needed to help improve fathers' own outcomes (e.g., reduced substance abuse and criminal activity), as 
well as the outcomes of their children (e.g., reduced stress, internalizing and externalizing behavioral 
problems). 
 
We make sure that the reading level of all materials is at or below the 8th grade reading level. We read 
items out loud to all participants and pause to make sure that they understand the material. We have an 
NIH Certificate of Confidentiality to protect participant responses to sensitive questions and to questions 
that might elicit information about illegal behavior that should remain confidential. We remind participants 
that they can skip any items that they do not wish to answer. We conduct extra training with research staff 
so that they understand the importance of confidentiality and sensitivity to vulnerable populations. 
 
While compensation will be provided, the amount of compensation we believe is not high enough to be 
considered overly attractive by participants as to take unwarranted risks or to affect the voluntariness of 
consent. We will also inform all study participants during the consent process that their participation will not 
in any way affect their parole or probation status, their sentence, or anything else related to their status as 
a formerly incarcerated individual. 
 
For any participants that are on probation or parole, we will not notify their probation or parole agent of their 
participation - unless if the participant requests/requires that we do so - and would not share any 
information obtained in the study should we be asked. We have a Certificate of Confidentiality to ensure 
this safety mechanism can be fully implemented. In the event that a participant were to ask if we can inform 
their probation or parole agent of their participation in the study or if the probation or parole agent were to 
inquire as to their participation, we would simply provide that the individual is participating. We will abstain 
from providing any specific details of the participant or their time in the study beyond enrollment. 
 Subject Recruitment 
 
The first tier of recruitment will be with fathers. Our first avenue for recruitment will be reaching out to 
participants from previous focus groups conducted with a congruent sample, as previously approved by the 
University of Wisconsin-Madison ED/SBS IRB (Study #: 2019-0409, PI: P. Charles). Participants in these 
focus groups filled out future contact forms which the study team will use to invite them to the community 
intervention. This recruitment will take place through phone calls, text messages, or email communications. 
 
Second, we will advertise with a flyer that is posted in places that individuals in the study might frequent 
(e.g., social service settings, clinics, community centers, libraries). Similarly, the study team will be creating 
a Facebook page to post flyers on. As per the IRB guidance 
(https://kb.wisc.edu/sbsedirbs/page.php?id=42376) simply posting recruitment materials through online 
platforms is generally not considered "Use of New Media" and since it will not be a means of data collection 
no privacy statement, terms of use, or consent is required. Again, these mechanisms of recruitment will not 
require any face-to-face communications and thus will fit any socially distanced guidelines that public 
health officials may have in place. In addition, we will host a Facebook Live Event using an already 
approved group recruitment script. Prospective participants will have the option of providing their name and 
contact information in a UW-M Qualtrics survey that will be available only to the research team. This will 
ensure confidentiality instead of the person providing the information publicly. 
 
A third avenue of recruitment will come from recruitment with partner agencies, such as JustDane referrals 
through their Journey Home, Phoenix groups, Renewal After Prison group, or service fair that is offered to 
individuals recently released from prison; The Beacon (day shelter for homeless populations) with their 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
array of services provided to vulnerable groups; Nehemiah's Man Up group for currently and previously 
incarcerated men; and the Urban League with their fatherhood and child support initiatives. We will post 
flyers at these agencies if allowed or send flyers via email, but also work with program staff there to identify 
and recruit potential participants if allowed. Through these processes, we will invite people to call or to 
meet virtually with the research team to get information about the community program and screen them for 
study participation upon initial contact. We will follow the lead of each individual community organization as 
to how they have been delivering services during the pandemic. For those holding groups virtually, we will 
inquire as to joining a session virtually, as well, to advertise and to tell interested/eligible individuals about 
our study and ask that they reach out to us via phone or email. 
 
Anyone who contacts the study team via email will be provided with the study flyer and basic email text 
with study details. 
 
Stated explicitly, through each of these approaches, interested participants will be invited to contact the 
study team (most likely via phone call, but also through email or text message via Google phone) for 
screening at a later time if not available to be screened on the spot at the time of original recruitment 
contact. During these contacts, research team members will provide more details and information 
regarding the community intervention and check inclusion criteria. As alluded to, group recruitment 
methods may also be used. For example, if a Phoenix group meeting is occurring at JustDane (previously 
Madison-area Urban Ministry) remotely, participants will be asked by staff ahead of time for their voluntary 
participation in a 10-minute group presentation in which one of the research team members will also join 
the group virtually to inform individuals of the study and possibly to participate if they are interested and 
meet the eligibility criteria. A project phone number will be given to participants to call to get more 
information. Flyers, group recruitment scripts, and phone scripts are all attached herein. 
 
Once a study team member verifies that a father is eligible for participation and he agrees, he will provide 
the name and contact information of the primary or secondary caregiver (depending on the status they 
currently hold, themselves). The caregiver will be contacted if the child is cared for primarily by the 
caregiver and not the father. Individuals who are caring for the focal children of participating fathers are 
identified as caregivers. Based on previous research, we expect most of these caregivers to be either the 
other biological parent or a relative of the child. 
 
The study team will then reach out to the caregiver to confirm interest in enrolling the child in the study 
through phone, text message, or email. If the caregiver does not respond or does not wish to have their 
child enrolled, we will notify the father that he may still enroll but that we will not be able to collect data from 
their child. We will place initial calls or send initial emails no more than 3 times to caregivers before ceasing 
communication. At that time, we will assume they are not interested in having their child participate, or 
themselves, and notify the father. 
 
If a father has more than one qualifying child, one child will be randomly chosen for participation. We will 
not require that a child be the biological child of the participating father. 
 
While staff at JustDane, the Beacon, Nehemiah, or the Urban League may help refer potential participants 
to the study, as would other service providers who have recruitment flyers at their locations, they will not 
actively recruit. If a potential participant were to inquire about the study or express interest, the staff at the 
respective agency would be instructed to refer the prospective participant to the study team for information. 
 
All participation will be voluntary for the study respondents.  
 
In addition to posting flyers at social service institutions, businesses, community centers, clinics, libraries, 
and churches with their permission, the research team will work directly with staff at community 
organizations (e.g., Just Dane) to share flyers and information about the study with individuals served at 
their agencies who might be eligible and interested. At no time, however, will staff at community agencies 
be asked to answer questions about the study or to explain study procedures. Instead, prospective 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
participants will be guided to contact the study team directly at the email address or phone number on the 
flyer. 
6.0 
BEHAVIORAL/SOCIAL INTERVENTION 
 Study Behavioral or Social Intervention Description 
The Pathways for Parents after Incarceration Program (P4P) is an 8-week intervention that focuses on strengthening 
parenting skills, building constructive co-parenting strategies, providing therapeutic social support, and connecting families 
to needed specialized services. P4P is based on an adapted version of Parenting Inside Out (PIO), a cognitive behavioral 
parent management skills training program originally designed for parents in prison. 
 
P4P is delivered remotely over Zoom (owing to the COVID-19 pandemic) but in real time. Participants first pick up 
materials needed for the intervention (e.g., intervention manual, laptop/tablet, office supplies, other materials), and then 
participate from home or other location of their choice. Eight didactic sessions (once per week for eight weeks) are 
completed along with eight therapeutic sessions (these run back-to-back). Trained PIO coaches deliver the didactic 
classroom portion and trained therapeutic clinicians deliver the therapeutic sessions. The PIO or classroom portion lasts 
2-2.5 hours each, and the therapeutic session is 1 hour each week (total time = 3-3.5 hrs/week).  
 
Staff who will administer the intervention must first complete a PIO training offered by the organization who 
owns the curriculum rights to the intervention, The Pathfinder Network (https://www.thepathfindernetwork.org/). 
Clinical staff who facilitate the therapeutic sessions must be trained and licensed clinicians in social work, 
counseling, psychology or related fields. Intervention fidelity will be monitored using the Parenting Inside Out 
Group Observation Feedback Form Score. Domains scoring in the low category (1=remediation is needed or 
2=a growth area) will signal inadequate fidelity requiring re-training and further monitoring. This will be done 
through individual meetings with the interventionist and with written feedback. 
 
 Study Intervention Compliance 
Adherence to the protocol will be assessed by documenting the number of participants recruited, 
consented and enrolled, and attendance of participants in weekly PIO and therapeutic sessions. 
Completion of study interviews (measures and qualitative interviews) will also be tracked. To remain an 
active participant in the study, participants must attend all PIO sessions and if any are missed, attend a 
makeup session with a coach. Attendance records are carefully monitored and tracked. Participants who 
drop out of the study once the sessions begin will not be replaced.  
7.0 
STUDY VISITS AND PROCEDURES 
 Screening and Enrollment 
[The Screening and Enrollment visits and procedures are described in detail below.] 
Informed Consent 
 
Father respondents will participate in an oral consent process to take part in the screening process. 
Using an oral consent script, the researcher will describe the purpose of the study, the screening 
process and its purpose, what questions will be asked on the screening instrument, and that the 
information collected during the screening process will be retained for research purposes 
regardless of whether they enroll in the study. Participants will then be asked whether or not they 
wish to participate in the screener to see if they will be eligible to participate in the full study. 
 
The potential participants who respond to community postings or to information materials that are 
provided by community partners will be instructed to email or call the study team. Contact details will be 
provided on information sheets and flyers. Potential participants who respond to the posted flyer or the 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
provided information will be asked to set up an over-the-phone time to complete the brief screening 
form and obtain contact information for the formal invitation and subsequent reminders for the 
intervention. If eligibility and exclusion criteria are met, they will be invited to participate in the full 
consenting process after the screening. 
 
Researchers will determine if they are legally eligible to provide parental consent for their child. If so, 
participating fathers will take part in the consenting process for the eligible child. Children will 
participate in the consenting process after the father consents. 
 
If the father is unable to legally provide parental consent for the child, researchers will determine if the 
caregiver is legally able to provide parental/legal guardian consent. If so, the caregivers will participate 
in the consenting process for the eligible child, children under the age of 5 will not provide assent, 
children 5-10 years old will participate in an oral assent process, and children aged 11-17 years old will 
participate in a written assent process. If neither the jailed parent nor the caregiver is legally able to 
give parental consent for the eligible child, based on the exclusion criteria the family will not be able to 
participate. 
 
The consent process will take place virtually or in person (assuming COVID safe) prior to baseline data 
collection. If the father is legally able to provide consent for the child, the study team member will meet 
with the father and child virtually (by video call or phone) or in person, prior to the first session. The 
research team member will read each consent form out loud to the participant to which it pertains. 
Following that, the team will ask for written consent on the forms. 
 
If the father is not the legal guardian and cannot consent for the child, the study team member will meet 
with the caregiver and child virtually or in person (similar to the procedure for fathers). The research 
team member will read each consent form out loud to the participant to which it pertains. Following that, 
the team will ask for written consent on the forms. 
 
Participants will receive the forms either through mail, email, or delivery through a safe procedure in 
which there will be no contact during the consent drop off. Once signed, participants will be allowed to 
either scan, take a picture and send, or coordinate for a safe and secure pick up in which a research 
team member obtains the form with no contact (e.g., taking it from a mailbox). If consent is done in 
person, the signed consent form will be obtained at that time. 
 
Fathers will sign a consent form that includes signed parental permission for the child. Children younger 
than 5 years old will not provide assent as we believe children ages 3-4 years old will not be able to 
understand the study. When developmentally appropriate, the researcher will describe the activity 
(asking interview questions) using language that is accessible to young children before engaging in the 
activity with the child. Children ages 5 to 10 years will be asked to provide verbal assent. Children ages 
11-17 will be asked to provide written assent. When the father is not able to give consent for the child to 
participate, the caregiver will be asked to provide consent instead. 
 
Screening Visit 
Once a prospective participant indicates interest in learning more about the study, the researcher sets 
up an appointment over the phone or over video chat (e.g., Zoom) and screens the participant for 
eligibility using an established screener form. Once determined eligible, the participant is asked if they 
would like to continue and complete the consent process. This session lasts approximately 20-30 
minutes. 
Baseline 
A baseline or pre-test survey is completed after the participant is deemed eligible and they complete 
the consent process. This is either done in the same session as the screener and consent or at another 
time. The baseline survey is estimated at 1.5 hours.  

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
Enrollment 
 
A research participant will be defined as “enrolled” in the study when they meet the following criteria: 
 
• 
The subject and study staff have completed all screening documentation and the person is deemed 
eligible. 
• 
The PI has verified that the subject meets all of the inclusion criteria. 
• 
The PI has verified that subject meets none of the exclusion criteria. 
• 
The subject has been consented by study staff.  
 On-Study/Follow-up Visits 
 
Each intervention visit consists of (1) participation in a parenting skills class followed by (2) participation in 
a peer support therapeutic group. The 8 sessions of parenting class include: 
1. Getting Acquainted and Destination Adulthood 
2. Effective Speaking Skills 
3. Effective Listening Skills 
4. Effective Problem Solving Skills 
5. Connecting with Your Child: (a) Bonding Through Play and Reading, (b) Parenting Adolescents 
6. Bonding through Emotion Coaching 
7. Directions and Encouragements 
8. Advocating for Your Children 
 
Parenting skills classes last 2-2.5 hours. They are delivered by two trained facilitators. They are delivered 
remotely over Zoom. Participants are at home or other location of their choice. Attendance is tracked. 
A 30-minute break is provided after the end of the parenting skills class. Then participants return to the remote 
Zoom session and participate in a therapeutic peer support group. These groups last one hour. They are 
facilitated by trained and licensed clinicians (e.g., social workers, counselors, psychologists).    
All procedures and activities are provided solely for research purposes. 
The final study visit for the intervention itself occurs after the final parenting skills class, usually one week later, 
where a graduation ceremony and celebration takes place. The final study interaction occurs three months 
after the post-test interview is completed when the 3-month follow-up interview takes place. 
 
 Early Termination/Withdrawal Visit 
Subjects who terminate or are withdrawn early from the study will have one final visit to follow up regarding 
adverse events, collect study materials that are on loan (e.g., computer or tablet), and if applicable, to refer 
person or family to appropriate support services in the community. 
 Long-Term Follow-up | Re-contacting Subjects 
Follow-up occurs three months post-intervention for final data collection. Otherwise, there is no further 
follow up that takes place. 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
8.0 
DATA HANDLING AND RECORD KEEPING 
 Data Collection  
We will retain de-identified screening data (which includes the initial 11 eligibility questions as well as the 
remaining demographic questions) so that we can determine who among those screened were ineligible for 
participation and why. To help protect a person’s identification, we will omit the day of someone’s birthday 
(MM/DD/YYYY) from the record for anyone who is screened but does not participate in the study. This will 
be informative to future studies about general interest in studies of this kind and screening criteria that 
might need to be changed. 
 
Potential participants will also be asked whether or not they would like to be contacted for future studies. 
Individuals who agree to this will provide their contact information to be recontacted over the phone or in 
person. The study team will store their contact information for future study eligibility. Contact for future 
studies would include other future studies not yet planned or funded. Retaining these data will be helpful for 
future study recruitment. 
 
Preliminary screen data regarding eligibility criteria will be stored in a locked file cabinet in a locked room at 
the School of Social Work. Only approved study personnel have access to the files. 
 
Individuals who agree to be contacted in the future will have their contact information stored in a secure, 
password ­protected file with only their name and contact information. 
 
Participants who do not enroll in the study and do not wish to be recontacted for future studies will have 
their contact information destroyed. 
 Confidentiality and Privacy 
Data collection conducted with fathers, caregivers, and children will generally be done on an individual 
basis (either alone or the father (or caregiver) and child together as appropriate). In most cases, survey 
completion will be done virtually. This will ideally be conducted through a virtual video-call in which 
research team members can share their computer screen with data collection instruments pulled up to walk 
the participant through the documents together. In other cases, this may be done through a phone call 
where the researcher reads prompts to the participants to answer. In as few cases as possible and as a 
last case scenario, survey completion may be completed in participant's homes, in private rooms located at 
local libraries, or in office space provided by partner community agencies through safe and socially 
distanced protocols. In all cases, the utmost precaution will be taken to ensure that other individuals are not 
in the vicinity and cannot overhear the researcher asking, or the participant answering questions. 
 
If someone else is in the location, we will continue with the interview only if other individuals are at a 
sufficient distance so as to be unable to hear the questions and responses. In no situation would an 
interview be continued or conducted if the privacy of the respondent would be compromised by the specific 
circumstances of the interview. 
 
 Records Retention 
The few questions audio recorded in the interviews will be digitally recorded and transcribed by the study 
team. Once the transcription has been verified by the PI, the audio file will be deleted. The use of audio 
recordings is important to allow for the interviewer to focus on the questions with the participants without 
having to take detailed notes that could yield less accurate data. 
 
Transcripts will be stored on campus resources for at least 7 years after the project ends per the research 
records retention policy. 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
Subjects will be notified in the consent form about the use of photos. The PI also has a photo release form 
that could be used in addition to obtaining permission to use photos of participants when disseminating 
findings. Photos, like the audio data, will be retained for at least 7 years after the project ends. 
 
 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol or investigational plan 
requirements. The noncompliance may be either on the part of the subject, the investigator, or the study 
site staff. As a result of deviations, corrective actions are to be developed by the site and implemented 
promptly. 
 
It is the responsibility of the Principal Investigator/site investigator/study staff to use continuous vigilance to 
identify and report deviations. The Principal Investigator is responsible for assessing whether the deviation 
constitutes noncompliance as defined by the reviewing IRB and if so, reporting it within the required time 
frame(s). The site investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
 Publication and Data Sharing Policies 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central 
(https://www.ncbi.nlm.nih.gov/pmc/) upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted 
to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. 
Data from this study may be requested from other researchers 5 years after the completion of the primary 
endpoint by contacting the PI, Pajarita Charles, paja.charles@wisc.edu.  
 
 
9.0 
STUDY ANALYSIS 
 Statistical Hypotheses 
• 
Primary Efficacy Endpoint(s):  
For feasibility and acceptability measures, we are not testing hypotheses. We are examining elements of 
the intervention to assess client acceptance of the treatment, ability to recruit sufficient numbers of 
participants, and feasibility of delivery with the clients and therapists in the treatment settings. 
 
• 
Secondary Efficacy Endpoint(s): 
We hypothesize that participants who are in the intervention will have improved relationship, parenting, 
parent-child, and mental health outcomes after completing the intervention.  Alternatively, our null 
hypothesis is that there will be no difference in the effects of the intervention for relationship, parent-child, 
parenting, and mental health outcomes.  

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 Sample Size Justification 
The sample size for this feasibility pilot study is based on previous research and not to formally test 
hypotheses. Its purpose is largely to develop an intervention, identify measures, and assess logistical 
nature of the proposed intervention. The secondary outcomes, while they can be tested in pre- and post-
test analyses, are included to determine trends or patterns of responses. 
 Subject Population(s) for Analysis 
Participants who completed the full intervention and the pre- and post-test interview (including both father 
and caregiver participants) will be included in the analyses. 
 Statistical Methods 
Primary outcomes will be assessed using descriptive statistics. Specifically, count data (e.g., number of 
enrolled participants who complete the intervention) are presented using percentages. Continuous 
measures presented as a score on a scale (e.g., provider adherence scores) are presented with means 
and standard deviations, and minimum and maximum scores. 
 
Secondary outcomes will be assessed using paired sample t-tests to estimate changes between the scales 
at baseline and post-test. Two-tailed tests with .05 p-values will be used. 
 Handling of Missing Data 
Complete-case analysis will be used and participants with missing data (i.e., missing post-test interview) 
will be excluded from the analysis.  
10.0 
RISK/BENEFIT ASSESSMENT 
 
Known Potential Benefits 
There are no direct benefits to subjects. However, there are potential benefits to participants which include 
the parenting strategies that the fathers will learn in the community-based program. 
 
The potential benefits for society derive from the scientific advances that may occur as a result of this study 
through intervention development and future efficacy and effectiveness trials. There is the possibility of 
public benefit because of the potential to positively influence previously incarcerated parents and their 
children. Additionally, information learned in the study may be used to inform the research and social 
welfare policy community to improve services provided to incarcerated parents that could prevent or reduce 
further criminal justice involvement and criminal behavior post-prison. 
 
 
Known Potential Risks 
 
There is a risk of a confidentiality breach. 
 
Participants may be upset by aspects of the research or content of the intervention program. 
 
Participants may reveal personal, sensitive, or identifiable information when responding to open-ended 
questions. 
 
Participants may reveal illegal behaviors due to the nature of the questions. 
 
Participants may become fatigued or frustrated due to the length of the study. 

Pathways for Parents after Incarceration 
 
Pajarita Charles 
 
 
 
 
 
 
Risk/Benefit Analysis 
Data will be stored securely according to campus policy; when necessary, identifiable or sensitive 
information will be stored separately from other study data and participant identities will be masked in 
publication and any other dissemination of study results. 
 
Participants will be informed about all aspects of the study during consent and have the option to skip or 
withdraw from any activities that make them upset or uncomfortable, including skipping any questions in 
surveys or measures. 
 
Personal, sensitive, or identifiable information is necessary to answer the research question(s) but it will be 
stored separately from other study data. 
 
If a participant reveals illegal behavior, it will either be removed from the research record. If the information 
is shared as part of an answer to the research question and is needed for the purposes of the study, the 
data will be protected by way of secure storage according to campus policy, as well as by a Certificate of 
Confidentiality that will be obtained after the PI receives IRB approval. 
 
Participants will be informed of the approximate length of study activities during the consent process and 
will be offered the opportunity to take breaks during the study activities if needed. 
 
Participants will be informed that although groups will be held virtually, sessions will never be video or 
audio recorded.