A Pilot Study of the Fathering Through Change Intervention for Fathers With Substance Use Disorders
Phase: NA
Conditions: Parenting, Substance Use
Sponsor: University of Oregon

12132019.029
A Substance Use Adaptation of Fathering Through Change 
July 8, 2021

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Research Plan 
IMPORTANT: When completing this outline, please use the Research Plan Guidance for the content necessary to develop a 
comprehensive yet succinct Research Plan. Using the guidance to complete this outline will help facilitate timely IRB review. 
Study Title: 
An Adaptation of Fathering Through Change for Fathers receiving Treatment for Substance 
Use Disorders 
Protocol Number: 12132019.029 
Principal Investigator: Camille Cioffi 
A.
Introduction and Background
It is well documented that children exposed to parental drug use are at greater risk for 
maladjustment, deviant peer affiliation, and substance use initiation. Parents living with Opioid Use 
Disorder (OUD) are at high risk for incarceration, family disruptions, health problems, and financial 
hardship However, research on drug abuse with men has largely neglected the role of fathering, 
parenting roles and parenting status for these men. Moreover, our understanding of the unique impacts 
of opioid misuse on fathering behaviors is even more limited than our knowledge base for mothers. The 
majority of extant research has been conducted on mothers, although there is evidence that more 
fathers than mothers enter into drug abuse treatment.  
Existing opioid research suggests there are marked parenting differences for fathers and mothers 
who misuse opioids. Compared to mothers, fathers are more likely to be misusing opioids when they 
first become a parent, and compared to fathers without a substance use disorder, fathers with OUD 
exhibit more concerning parenting behaviors and report other limitations that may impact their 
children. For parenting specifically, compared to fathers without OUD, OUD fathers report lower 
parental efficacy, engage in fewer positive parenting behaviors such as consistency and positive 
involvement, and report less satisfaction with the parenting role compared to mothers. Fathers who 
misuse opioids also report greater prevalence of violence towards their child’s mother both over the 
course of the relationship and report greater violence perpetrated against them by their child’s mother. 
Within the preventive intervention and treatment research, fathers are vastly underrepresented in 
studies of parent training relative to mothers, with only a handful of studies including father-related 
outcomes. Less is known about fathers who do or do not misuse opioids, or what mechanisms are 
unique to opioid use that interfere with effective parenting. The goal of this pilot is to better understand 
the unique, specific, influence of opioid misuse on compromised fathering behaviors, and further, how 
misuse uniquely affects the process of intervention uptake. We will use Fathering Through Change, an 
evidence-based parenting intervention which has been found to be efficacious for positive changes in 
fathering mediated by changes in pare parenting efficacy and fathering identity.  
B.
Specific Aims/Study Objectives
Aim 1: Document Baseline Differences Among Opioid Misusing and Non-Opioid Using (other substance
using) Fathers and Child Functioning (note, we are recruiting from substance use treatment centers and
substance use related pages on social media so some fathers use opioids while others do not just by
nature of who attends treatment)
Aim 2: Understand how Opioid Misuse is related to treatment outcomes and whether the intervention
shows promise for this population

 
 
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C. Methods, Materials and Analysis 
This study will include two procedures; Procedure 1 is for the intervention study and Procedure 2 is for 
the baseline study.  
Procedure 1 for the intervention study is a randomized-control trial of the Fathering Through Change 
(FTC) intervention. Our goal is to recruit up to 120 participants and randomly assign them to either 
intervention or control. Treatment centers throughout the state of Oregon will help to facilitate 
recruitment. They will do outreach to men currently receiving treatment services and to men who have 
received treatment from the respective treatment centers in the past. Individuals who receive 
communication from a treatment center may also share that information with their peers in recovery. 
Those individuals will also be welcome to participate if they meet the inclusion/exclusion criteria. The 
clinician does not have to be vetted by in order to provide services for men currently receiving 
treatment since they are not an employee of any treatment center and have been vetted by the 
University of Oregon. Additionally, the study will recruit participants by advertising on social media 
websites, specifically Facebook and Reddit. Public account pages will be made on each platform to 
advertise the current study. The recruitment flyer and posted text (see “Fathering Through Change (FTC) 
Intervention Research Study.pdf” and “Facebook or reddit example posting.docx” will be posted on both 
platforms. For Facebook, the flyer and posted text will be posted to groups related to 
heroin/opioid/substance use recovery and parenting. For Reddit, a similar process will occur, such that 
the flyer and posted text will be posted to "communities" that relate to heroin/opioid/substance use 
recovery and parenting in recovery. In addition to the flyer and posted text, contact information will be 
shared that can connect interested individuals with affiliated research personnel. All individuals 
expressing interest in the study will be directed to contact the project coordinator to complete the 
eligibility screener. 
All eligible and consented participants for Procedure 1 will be invited to take three sets of surveys using 
Qualtrics or RedCap. IP address tracking will be enabled for all surveys in effort to increase security 
measures and reduce fraudulent survey submissions. First at baseline (pre); second, at 6-weeks later 
(post); and lastly, at 4 months from baseline (follow-up). Surveys will be conducted online on the 
participants electronic device and will be formatted for administration on a computer, tablet, or 
smartphone. Surveys will assess the parent-child relationship, child behavior, parent mental health, 
parent substance use, intervention knowledge gained and satisfaction, and participant context. The 
baseline questionnaire will take approximately 95 minutes. The post questionnaire will take 
approximately 90 minutes. The follow-up questionnaire will take approximate 90 minutes. 
These are the steps for participation: 
1. Treatment center sends out text messages and emails to current and past male clients. They will not 
send out text messages and emails to current in-patient clients because these clients do not have access 
reliable access to technology (not allowed to use it). The text message will contain information to contact 
the study team. Formal recruitment will occur when the potential participant reaches out to the study 
team via phone or email. For Facebook and Reddit recruitment, the project coordinator will post the 
recruitment flyer to groups and communities on both platforms. All interested individuals will contact 
the project coordinator and complete the formal recruitment process including the eligibility screener.  
See Text Messages document. 
2. For both Procedure 1 and Procedure 2, the study team will respond to interested participants with an 
enrollment text from a google voice number or study specific email. They will first ask screening 
questions to determine eligibility. If a participant is eligible, they will provide a link to the electronic 
survey.  

 
 
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 See Text Messages document. 
3. The first page of the survey will take participants to a screener to ensure they are eligible to 
participate. We will screen for past 18 month (Procedure 1) and 36 month (Procedure 2) abstinence from 
illicit substance use (For Procedure 1, must have less than an 18 months of abstinence from illicit 
substances. For Procedure 2, must have less than a 36 months of abstinence from illicit substances), 
child in appropriate age range and at least two hours per week spent with child. Regarding Procedures 1 
and 2, participants who are ineligible will be taken to the end of the survey and will not receive follow-
up. Participants who are eligible will complete the informed consent process electronically. After 
consenting, they will take the baseline questionnaire survey. In the baseline survey, we will include a 
questionnaire related to the psychological and parenting consequences of COVID-19 (see “Measures 
Overview_8_31_20.docx”) to better understand the impacts of COVID-19 on fathers’ parenting, ability to 
care for their child(ren), distress, and potential substance use cravings and use.  
4. For both Procedures 1 and 2, during the survey, they will provide their contact information so that 
they can receive either an electronic gift card or check in the mail, depending on their preference as an 
incentive. This information will also be used to provide them with study materials, reach out for follow-
up surveys (Procedure 1), and link participant data overtime (Procedure 1).  
5. For Procedure 1, once they have completed the questionnaire, they will receive a follow-up text 
message and email (at least one method depending on information given) within one week to welcome 
them to the study. Different messages will be provided depending on whether a participant is assigned 
to the control or intervention group. Random assignment will occur using a random number generator 
in batches of 10 (up to 100 pre-determined for eligible participants- assigned at the time of enrollment) 
to ensure the design is balanced if our sample size is smaller than expected.  
6. For Procedure 1, the PI will provide videos to the participant on a weekly basis for 6 weeks. The 
participant will have the opportunity to take a brief knowledge test after watching each video to earn an 
additional $5 per knowledge test completed. The PI will schedule appointment for the coach to call via 
text or email with participants. 
See Text Messages document. 
7. For Procedure 1, the clinician will call participants at the designated appointment time using a google 
voice number at week 1, week 3, and week 5. Since these are just opportunities to check-in, if a 
participant misses their appointment, they will have the opportunity to check-in again. However, this will 
be the participants responsibility- the PI will not make another attempt to schedule a coaching call. If the 
participant asks to check-in via text instead, the clinician may also use the google voice number to check-
in via text using the same script. Please note that the coaching calls document is a loose script and may 
be adapted by the clinician. The clinician is responsible for providing notes after each call, but calls will 
not be recorded. 
See Coaching Calls document. 
8. See Text Message document for a full overview of when participants will be contacted for each 
component of the study and what content will be provided. 
Procedure 1:  
Control  
(approx. 40 fathers) 
Intervention Condition  
(approx. 40 fathers) 
Services as Usual: 
All Services as Usual PLUS 

 
 
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Current or previous substance use disorder 
treatment 
Medication Assisted Treatment (if applicable) 
Some Parenting Coaching if still in treatment 
 
Fathering Through Change Intervention: 
6 weekly video clips, texted to their phone, 
approximately 5-15 minutes per week with a 
follow-up knowledge quiz (see Text Message 
document) 
Opportunities for three 20 minute check-ins with 
a clinician (Jones) who is not affiliated with any 
treatment center 
Will receive a certificate of completion 
 
Procedure 2 for recruiting participants only for the baseline survey: 
For Procedure 2 interested individuals will text or email “I’m Interested” to the study phone number or 
email. The project coordinator will complete the eligibility screener and, if eligible to participate, send the 
eligible indidivudal the link to the Qualtrics survey. If eligible to participate, the survey will continue to 
inform the eligible individual to review the consent form (see “Informed Consent_Baseline only_A6.docx”). 
Once consent is completed, the participant will complete the baseline survey that includes the same 
questionnaires from the previously approved baseline survey of the intervention study. Participants will 
have the opportunity at the end of the Qualtrics survey to indicate if they consent to be re-contacted for 
future research studies; in effort to potentially enroll them in the intervention study (Procedure 1). 
Participants will be compensated $50 for completing the baseline survey.  
Procedure 2 will recruit participants through both social media and treatment center outreach.  
Treatment centers previously contacted for Procedure 1 will be contacted via email (see "email template for 
treatment centers_baseline.docx") to send them a flyer (see "Baseline only FTC flyer.pdf").For social media, 
we will recruit participants by advertising on social media websites, specifically Facebook and Reddit. Public 
account pages will be made on each platform to advertise the current study. The recruitment flyer and 
posted text (see “baseline only FTC flyer.pdf” and social media template_baseline.docx”) will be posted on 
both platforms. For Facebook, the flyer and posted text will be posted to groups related to 
heroin/opioid/substance use recovery and parenting. For Reddit, a similar process will occur, such that the 
flyer and posted text will be posted to "communities" that relate to heroin/opioid/substance use recovery 
and parenting in recovery. 
In effort to reduce fraudulent survey submissions anticipated from posting our study on social media 
platforms, three  actions will be taken: 1) we will remove the compensation option "giftcard by text" and 
prompted "if receiving mail is a problem for you check this box" followed by the option to indicate, "I don't 
have a mailing address. Please follow-up with me", 2) implement IP address restrictions on the Qualtrics 
survey settings, and 3) add three fill in the blank attention checks to assess for fraudulent and bot responses 
(see "example attention check questions.docx").  
Analysis Plan The research does not involve any procedures typically used in a biomedical/clinical setting 
and/or administration of medications. To address aims, we will use quantitative analyses including, t-tests, 2 x 
2 ANCOVAs and MANOVAs, for test of mediation and moderation we will specify structural equation path models. 
Identifiable information will be collected but data will be reported anonymously. Research will be disseminated at 
conferences and through scientific journals, and press releases. Findings will also be shared through outlets 
deemed appropriate by the larger center this study is a part of (noted in the funding and sponsorship form). 
D. Research Population & Recruitment Methods 
 

 
 
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Procedure 1 (Intervention Study): The participant population are fathers who are in recovery from 
substance use disorders and have been abstinent from illicit substances for less than 18 months. 
Participants must be over the age of 18 years old. Our primary intervention target is fathers with opioid use 
disorder and efforts will be made to prioritize fathers who have specifically misused opioids in the past.  
Fathers are eligible to participate if: 
1. They identify as being in recovery and have been abstinent from illicit substances for at least 1 day and 
less than 18 months. 
2. They have parenting responsibilities for a child between the ages of 3-16 who they spend at least 2 hours 
per week with.  
3. They speak English. 
4. They are 18 and older. 
The project coordinator will complete the eligibility screener via text message or phone call. Individuals will 
be asked to describe their recovery and family situation to the project coordinator through open ended 
questions. Individuals will be excluded if they do not meet eligibility criteria, or if they deny answering 
questions about their recovery and family situation. Individuals will be excluded if they cannot speak English 
because they will not be able to understand intervention content and will not be able to participate in 
surveys. Father’s must have potential to have some contact following treatment since the intervention is 
targeted at improving parenting skills. Fathers of children younger than 3 or older than 16 will be excluded 
because the intervention is not suitable for children outside of the age range 3-16. 
The total number of participants will not exceed 80 for procedure 1. Our goal is to recruit approximately 40 
fathers to the intervention condition and 40 fathers to the control condition. This will provide enough data 
to compare effectiveness between condition and also to examine the effects of different substances on 
intervention outcomes. We expect these numbers may be less due to COVID-19. 
The PI or a research assistant will recruit participants. If a research assistant recruits participants, they will 
be trained by the PI to use the Text Message script. See the Text Message document for screening 
procedures. Language and device access will not be specifically screened for, because participants would 
only be able to contact the study team if they read the delivered text which was in English and could 
respond to the questions we are asking. We believe asking this question would place an unnecessary 
burden on participants. 
The individuals who will recruit participants have not and will not provide treatment or care to the 
prospective participants.  
The clinician also has a role in intervention development. The clinician will not have access to the data to 
diminish undue influence.  
There are no costs to the participant or third party.  
Participants will receive $25 for the baseline questionnaire, $50 for the post questionnaire, and $75 for the 
follow-up questionnaire. Participants in the intervention condition will also receive $5 per knowledge quiz 
they complete (up to a total of $30). Participants in the intervention condition will receive a certificate of 
completion indicating the number of video session completed (as indicated by the number of knowledge 
tests completed) and the number of coaching calls participated in. Participants will be given the choice to 
receive either a check in the mail or electronic gift card following each survey. Individuals participating in the 
intervention will receive a lump sum for all knowledge tests they completed at the end of the intervention 
and will similarly be given the choice to either receive an electronic gift card or check in the mail.  
Participants will be texted after they complete the baseline survey and before they receive the Week 1 texts, 
"You have the opportunity to receive additional cash incentive: if you refer someone to the study who is 

 
 
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eligible to participate, you will receive an additional $5 incentive. You can refer up to two people. Make sure 
to instruct the referred individual to provide your name when they take the survey in order to receive 
incentive. Importantly, you will only receive the $5 incentive if the person you referred meets eligibility 
criteria. Feel free to contact the research team with questions or request for details regarding eligibility 
requirements, (458) 215-1034." (see “Text Messages” script). Participants will only receive the incentive 
payment(s) if the person(s) they refer is deemed eligible for participation.  
 
Participants will have the opportunity to communicate if they were referred by someone within the baseline 
survey in Qualtrics. We will add a display logic question: "Did someone refer you to participate in this 
study?" If so, "What is the name of the person who referred you?" (see “Baseline_referral questions.docx”). 
We will cross-check the identified name in our database to document referral and initiate reimbursement.  
Participants will have the opportunity to communicate how they heard about the research study within the 
baseline surveys in Qualtrics for Procedures 1 and 2. We will add a fill in the blank question, “how did you 
hear about this study?” to track how participants learned about the current study they are engaged in.  
In attempt to reduce bias: 1) each participant will be limited to two verified recommendations, 2) only the 
first 20 participants will be provided this option to refer someone to the study.   
 
Participants are being incentivized more at the post and follow-up surveys to improve the likelihood of 
longitudinal data collection.  
 
Procedure 2 (Baseline Only Survey): The participant population are fathers who are in recovery from 
substance use disorders and have been abstinent from illicit substances for less than 3 years (36 months). 
Participants must be over the age of 18 years old. Our primary intervention target is fathers with opioid use 
disorder and efforts will be made to prioritize fathers who have specifically misused opioids in the past.  
Fathers are eligible to participate if: 
1. They identify as being in recovery and have been abstinent from illicit substances for at least 1 day and 
less than 3 years (36 months). 
2. They have parenting responsibilities for a child between the ages of 3-16 who they spend at least 2 hours 
per week with.  
3. They speak English. 
4. They are 18 and older. 
The total number of participants will not exceed 120 for the baseline only survey. This number includes the 
participants who also participated in procedure 1 so we would recruit 120-number recruited for procedure 
1. We anticipate that recruitment is finished for procedure 1 and we have enrolled only 41 subjects, thus, we 
expect that no more than 79 participants will be recruited for the baseline only survey.  
Similar procedures for virtual recruitment from procedure 1 will be followed in the event of virtual 
recruitment for procedure 2. For procedure 2, the project team may travel to treatment centers to complete 
the eligibility screener and offer the chance to complete the survey in person via an iPad. Treatment centers 
will allow the research team to be present on site, and will provide an indoor or outdoor space that allow for 
sufficient spacing and privacy to mitigate risks associated with COVID-19 transmission and loss of privacy. 
The treatment centers will let fathers know that the study team is on site and fathers will voluntarily 
approach the study team in a location where the study team is not able to see treatment center attendees 
to mitigate HIPAA privacy concerns. We will work with treatment centers who consent to in-person 
recruitment to determine the best process to talk with clients while on site. This might vary based on the 
type of treatment center. For example, the Methadone clinic has people coming and going regularly, thus 

 
 
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the option to set up a booth might be an effective strategy to be visibly available to anyone walking through. 
Another example is that outpatient treatment centers might allow us to be present on site before or after 
groups. For inpatient treatment centers, they might want us to visit during meal times to talk with 
individuals while they are eating and discuss the research study opportunity. A member of the project team 
(the PI, RA/Project Coordinator, or Co-I) will use the in-person recruitment script (see “in person recruitment 
script.docx”) provide the participant with an iPad to facilitate the informed consent process and research 
survey. If we do not have enough iPads at any point, we will encourage individuals to complete the survey 
on their phone or mobile device. We will have paper copies of the survey as back up if needed or preferred 
by individuals. All paper copies will be stored in a locked cabinet within a locked room that only the PI has 
access to. All paper copies will be double-entered for quality assurance. A member of the project team will 
provide the participant with their incentive upon completion of the survey. Tabling to recruit participants 
may also happen virtually, if preferred by treatment centers. For virtual tabling, a research assistant will 
attend online group meetings, with permission from the treatment center, to present the opportunity to 
participate to clients. Treatment center staff will provide the study flyer to clients and interested individuals 
will be instructed to contact the study email or phone number. Virtually tabling will occur using secure wifi 
and using a link provided by the treatment center or the research assistant's HIPAA protected zoom 
account. 
 
For in person recruitment, all safety protocols will be followed in accordance with the University of Oregon’s 
Stage 1 and 2 Research Activities protocol. The Stage 1 and 2 form will be completed and submitted 
separately.  
 
Participants who complete procedure 2 (the baseline only survey) will be compensated $50 via  check or gift 
card in the mail, sent electronically or provided in-person if research is conducted in-person. If participants 
do not have a mailing address, they will have the opportunity to indicate as such and provide a phone 
number for the project coordinator to follow-up.  
E. Informed Consent Process 
Informed consent for Procedure 1 and Procedure 2 will be collected electronically. Individuals will consent to 
participate at the beginning of the survey by clicking that they consent to participate after reading the 
consent form and by typing their name and the date "(type name and date:__________)" . They will also 
complete a consent quiz to check for understanding. Incorrect answers will be followed up with the correct 
answer and then participants will be permitted to proceed. Participants will be provided a copy of the 
informed consent using the same process they select for receiving payment (email, mail, or in-person). 
This research will not involve minors or individuals of diminished capacity given the requirements of 
treatment centers. The research was designed the research to only solicit anonymous 
information about children from the fathers to avoid having to engage children in the research. 
 
We are requesting a waiver of documentation of informed consent. The research presents no more than 
minimal risk of harm to subjects and involves no procedures for which written consent is normally required 
outside of the research context. 
 
There will not be any deception. 
The investigators will post a copy of the consent form as required and will use the study’s established 
registration at clinicaltrails.gov to post the document within the required timeframe.  

 
 
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F. Provisions for Participant Privacy and Data Confidentiality 
1. Privacy 
During the intervention, it will be up to participants to disclose vulnerable information about their previous 
experiences with parenting. It will be their choice to disclose such information during coaching calls 
however, in services as usual, they would disclose similar parenting information. 
To promote protection of privacy \ during coaching calls there will be a designated time decided on by the 
participant when the coach will call. The coach will not disclose that the participant is a research study when 
the call is made in case someone else answers the participant’s phone.  
Regarding privacy protections for mailing payments to Procedure 2 participants, return envelopes will be 
labeled with “University of Oregon Prevention Science Institute” without a reference to the study and in the 
check note, “CPO Pilot 2”. The envelopes and checks issued for payments will not include the study title nor 
other information on outward facing materials that would indicate the participant is in recovery. 
2. Data Disposition 
Identifiable participant information will be collected in Qualtrics or RedCap during each survey Following 
data collection, identifiable data will be removed, and a unique identifier assigned for all analyses.  The 
clinician will only be given the participants first name and phone number to maintain confidentiality. 3.  
3. Confidentiality 
The only individuals with access to identifiable participant information on Qualtrics or RedCap will be the PI 
and advisor. The code and key will be retained in a locked file on the Prevention Science Institute (at 
University of Oregon) server with permissions granted to only Cioffi and DeGarmo. 
Participant identities will not be disclosed as a result of this research. 
Storage of data will be stored electronically on a private server and will be directly uploaded only while using 
secure wifi. If the data must be transferred, they will be transferred using a secure client server. Only the PI 
and advisor will have access to the data. Students may be granted access to the data after signing a data use 
agreement, in order to complete analyses. Records will be kept for up to 3 years after the study has been 
completed.  
Participants will be informed that researchers are mandatory reporters and are required by law to report a 
situation if they have reasonable cause to believe that any person with whom they come into contact has 
abused a child. 
Research funded by NIH automatically has a Certificate of Confidentiality associated with it. This is added 
protection against forced disclosure of research information in circumstances of subpoena. 
 
Sharing data  
This research study is part of a larger set of related studies being conducted by the Center on Parenting and 
Opioids (CPO; cpo.uoregon.edu), a National Center co-located at UO’s Prevention Science Institute (PSI), UO’s 
Center for Translational Neuroscience (CTN) and Oregon Health and Sciences University (OHSU). The 
research at CPO is funded by an award from the National Institute on Drug Abuse (NIDA).  
De-identified data collected as part of the current protocol will be shared to a central data repository 
maintained by CPO. The repository will house de‐identified data collected from all research projects within 
CPO. Data will be coded with a unique identifier that cannot be linked to any identifiable information. The 
repository is encrypted, and password protected behind firewalls. This expectation for data sharing is in 
accordance with guidelines from national funding agencies (e.g., see NIH Data Sharing Policy here: 

 
 
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http://grants.nih.gov/grants/policy/data_sharing/index.htm). Therefore, we will ask participants to consent 
to sharing their de-identified data to the data repository created and managed by CPO. 
G. Potential Research Risks or Discomforts to Participants 
Information risks, psychological risks, and social risks may occur as the result of participating in this study. 
Information risks include loss of privacy and/or breach of confidentiality. Since data will be collected using 
only private wifi (except when participants are not connected to secure wifi) and will be stored on a secure 
server, it is unlikely that loss of privacy will occur. A breach of confidentiality may occur if the clinician 
discloses identifiable participant information. The clinician will be asked sign a confidentiality agreement 
before providing services. 
Psychological risks may occur such as guilt or loss of self-esteem while receiving or not receiving parenting 
intervention services. It is likely that both the treatment as usual and the treatment conditions will improve 
fathers’ sense of responsibility without inducing guilt and improve self-esteem but not everyone receives 
treatment uniformly. Participants will be encouraged to seek services if they are in need of additional 
support. The clinician will be responsible for providing these resources as part of the services they provide 
to the study. 
Social risks may occur as a result of receiving services in the participant’s home (i.e. watching videos and 
phone coaching calls- no one will physically be in the participants home). Specifically, participants might feel 
uncomfortable engaging in the intervention if they do not have a private space to participate.  
All risks will be communicated in the informed consent process. 
The protocol involves intervention. The intervention includes watching videos that have been used for prior 
research studies with divorced and separated fathers. It also includes on-on-one parenting coaching with a 
clinician who is a trained clinician. This research does not pose any additional risk over the services provided 
as usual since fathers in treatment also receive services aimed at improving parenting via phone as part of 
standard practice at treatment centers (not as part of the proposed intervention).   
The funding agency required a Data Safety Monitoring Plan for this research at the time of funding proposal. 
A copy of the DSMP submitted to the funder is attached; however, it should be noted that there are some 
discrepancies due to the evolution of the project following proposal. The discrepancies are documented in a 
separate Memo to File. The key differences are that no information is being obtained from the treatment 
facilities, and the research no longer plans to include families and children as subjects. We are no longer 
excluding fathers of children with a developmental disability since children are not research subjects. Only 
fathers will participate. Additionally, our sample size is now 120 instead of 80. There will be three points of 
data collection rather than two. All other key components of the DSMP as proposed persist including the 
defined roles and responsibilities, procedures for monitoring site performance, procedures for monitoring 
data integrity, protecting confidentiality, and safety reporting and monitoring. Additionally, in the event of a 
crisis such as expressed elevated suicidality or intent to harm self or other, Jeremy Jones, who is currently 
receiving supervision to obtain licensure, will create a safety plan with the client (attached) and will make a 
referral to the appropriate agency such as the emergency department, back to the treatment center they 
are receiving services from if the client is currently receiving services, a local therapy center such as Options 
Counseling, or Child Welfare if warranted.  
There is no established Data and Safety Monitoring Board/Committee (DSMB/C) as noted in the DSMP. 
H. Potential Benefits of the Research 
Individuals may receive benefits from participating in this research such as improvements in parenting skills 
and the opportunity to form relationships with other fathers who might have experienced similar situations. 

 
 
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As a result, relationships between the participant and his child may improve as well as the relationship 
between the participant and the child’s other parent. 
By participating in this research, the research team will be able to learn whether the intervention would be 
generally useful for fathers receiving drug and alcohol treatment. 
I. 
Investigator Experience 
The PI (Dr. Camille Cioffi) is a research associate at the Prevention Science Institute and Co-I part of the 
Center on Parenting and Opioids.  She has experience volunteering with individuals with substance use 
disorder. She has provided support to the Environmental influences on Child Health Outcomes study (PI 
Leslie Leve) related to IRB submissions and the creation of survey materials. She has experience 
administering surveys to parents with low income as an undergraduate research assistant in the 
Developmental Sociobiology Lab (PI Jeffrey Measelle) and through her work as PI on the Voluntary 
Pregnancy Screening at Syringe Exchange study.  Cioffi has extensive experience conducting in-person 
research related to COVID-19 testing as a Co-I on two federally funded grants to provide COVID-19 testing to 
Latinx communities and syringe exchange clients, respectively. She will ensure appropriate precautions are 
taken to prevent the transmission of SARS-CoV-2 infection while conducting research.   
The co-investigator, Dr. Dave DeGarmo has led several randomized control trials including a randomized 
control trial of the Fathering Through Change intervention and other adaptions of Parent Management 
training for fathers. He is a researcher at the Prevention Science Institute and is the leader of the Data 
Science Core for the P50 Center as a whole. He provides mentorship to the PI. 
The clinician, Dr. Jeremy Jones has a master’s degree in Special Education and a doctorate in School 
Psychology and possesses in-depth experience providing evidence-based interventions for children and 
families. Dr. Jones has considerable expertise in parent training, having been certified as a Parent 
Management Training – Oregon (PMTO) Specialist, Coach, and Mentor. In addition, to providing direct 
intervention services, Dr. Jones has unique experience in conducting large scale (e.g. states and countries) 
implementations of Parent Management Training - Oregon (PMTO) across a variety of settings, including, 
child-welfare, community-based mental health systems, and schools over the past several years. Of 
particular importance for this project is that Dr. Jones specializes in working with fathers, and served as a 
Co-investigator and content expert on a recently completed SBIR (R44HD075499-02) where along with 
colleagues successfully adapted PMTO for recently divorced fathers and developed Fathering Through 
Change, an Internet-based program designed to be delivered through court systems.  This study is an 
adaptation of the previous FTC program. 
2. Roles and Research Duties 
The PI or research assistance will consent participants and administer on-line surveys. The clinician will 
deliver the intervention. 
The PI and faculty advisor will be responsible for data management, reporting, and science communication. 
The PI and faculty advisor will also be responsible for documenting program changes. 
3. Training and Oversight 
The clinician, Jeremy Jones has previous experience conducting similar parenting coaching intervention to 
those being used for this study. There is no certification for delivering the intervention however, on previous 
studies, Jones has demonstrated high adherence to the intervention principles. Training may be provided to 
graduate student research assistants or treatment center personnel by the clinician. If any trainees are 
used, they will be added to the protocol and will be part of the calls/delivery of the clinician coaching and 
will receive clinical supervision by their University department. 

 
 
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Graduate student research assistants will complete CITI training, and will be supervised by the PI. They will 
be responsible for the delivering the text message script and will review PI-participant text messaging 
records for training. The PI will review all text exchanges to ensure there are no ethical concerns and to 
provide feedback.