Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment
Phase: NA
Conditions: Intimate Partner Violence
Sponsor: Yale University

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HRP-503E– Protocol for Social or Behavioral Science or Educational Research
(2017-1)
Protocol Title: Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce 
IPV and Child Maltreatment
Principal Investigator: Dr. Carla S. Stover, PhD
Version Date:   October 31, 2023
(If applicable) Clinicaltrials.gov Registration #: NCT04165291
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Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system. 
Glossary of Acronyms
IPV
Intimate Partner Violence
CM
Child Maltreatment
PFDP
Parent and Family Development Program
UCONN
University of Connecticut
F4C
Fathers for Change
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BIP
Batterer Intervention Program
RF
Reflective Functioning
ER
Emotion Regulation
SECTION I: GENERAL INFORMATION
1.
Probable Duration of Project: State the expected duration of the project, including all follow-up and 
data analysis activities.  
9 years (for both Phases I and II)
2.
Study location: State where the study will take place and in what setting. 
Yale University Child Study Center and the Department of Psychiatry will be the locations for this 
research study.  Participants may l be recruited, consented, assessed and receive study 
treatments at the Parent and Family Development Program (PFDP) Clinic at 350 George St, a 
licensed adult and child mental health clinic on the Yale School of Medicine Campus or via Zoom 
secure conferencing is in person meetings are not feasible.  
If international, complete and submit International checklist (http://your.yale.edu/policies-
procedures/forms/450-ch-1-international-research-checklist) Note: If your research involves interactions 
with any embargoed countries you should contact the Director of Corporate Contracts and Export Control 
Licensing (Donald.Deyo@yale.edu or call 203.785.3817) for guidance on how to proceed.   
3.
Help us categorize your research. Are you using any of the following?
☐ Class Project
☐ Participant Observation
☒ Interviews
☒ Surveys
☐ Focus groups (study is not anonymous)
☐ Research in K-12 schools (submit a School Agreement form for the study)
☐ Deception (submit a Debriefing sheet)
☒ Audiotaping, videotaping or photography of individuals (study is not anonymous)
☐ Public viewing of videotapes or photographs 
☐ Yale Psychology Pool (study does not qualify for exemption)
☐ International research sites (attach the International Checklist)
☐ Online (web-based) activities
☐ Social networks
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SECTION IV: RESEARCH PLAN
1.
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
This project proposes to conduct important Stage I and Stage II treatment development steps to 
test the efficacy of Fathers for Change (F4C) compared to Batterer Intervention Program (BIP). 
Aims for Phase I:   
1.
Develop a revised BIP manual for individual treatment delivery as a comparison treatment.
2.
Develop a fidelity measure to distinguish F4C from BIP for therapist fidelity coding.
3.
Establish acceptability and feasibility of F4C compared to traditional group BIP (BIP-G) 
and an individually delivered BIP (developed in aim 1 above; BIP-I). We will test the 
following specific research hypotheses: 
i.
Fathers randomized to F4C will have higher completion rates than those in either the 
BIP-I or BIP-G treatments.  
ii.
Fathers will report greater working alliance and satisfaction with F4C than either BIP 
condition
4.
Assess initial intervention signal of F4C compared with BIP-I (developed in aim 1 above) 
and a group format BIP-G (current standard of care) program of comparable length. We 
will test the following specific research hypotheses: 
i.
Fathers receiving F4C will evidence greater improvement in reflective functioning (RF) 
and emotion regulation post-intervention compared to fathers receiving BIP-I or BIP-G.   
ii.
Fathers receiving F4C will show greater reductions in intimate partner violence (IPV) 
and child maltreatment (CM) over the 18 weeks of treatment compared to fathers 
receiving either BIP condition.
iii.
Fathers receiving F4C will maintain reductions in IPV and CM in the 3 months 
following treatment.
Exploratory aim Phase I: 
5.
Test whether improved RF and emotion regulation are associated with reduced IPV and 
CM consistent with the F4C mechanisms of change We will test the exploratory 
hypothesis: 
i.
RF and emotion regulation will mediate the association between treatment group and 
IPV and CM outcomes at follow-up.
Aims for Phase II:
AIM 1. Compare F4C to a standard BIP in its efficacy to reduce FV by decreasing fathers’ 
violent behavior, improve father-child interactions, and reduce child mental health 
symptoms. Hypotheses. Children of fathers who receive F4C (n=140), relative to BIP (n=140), 
will: (1a) experience less FV, (1b) have more positive father-child interactions, and (1c) have 
lower FV-related mental health symptoms (PTSD, internalizing/externalizing) at post treatment 
and 6- and 12-month follow-ups. The effects of both treatments on father and coparent mental 
health outcomes will also be examined (1d exploratory).
AIM 2. Identify and compare latent change profiles of therapeutic targets (RF, ER) in F4C 
and BIP fathers across the 18-week intervention. Hypotheses. Compared to BIP, more F4C 
fathers will show profiles of healthy change in therapeutic targets: (2a) masked coding of in-
session RF/ ER (i.e., increased RF and adaptive ER, decreased maladaptive ER), and (2b) 
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between-session self-reported RF/ ER (i.e., increased RF and adaptive ER, decreased 
maladaptive ER). F4C change profiles will reveal critical junctures in treatment that precipitate 
change, thereby serving to optimize timing/delivery of treatment components (2c, exploratory). 
AIM 3. Examine the mediating role of therapeutic change targets (RF, ER) on child-related 
outcomes in F4C and BIP families. Hypotheses. Profiles of healthy change in RF and ER will 
mediate the treatment effect of F4C over BIP on: (3a) FV (3b) father-child interactions, and (3c) 
child mental health symptoms (PTSD, internalizing/externalizing) at post-treatment and at 6- and 
12-month follow-ups. 
2.
Background: Describe the background information that led to the plan for this project. Provide 
references to support the expectation of obtaining useful scientific data. 
Eighteen percent of children in the United States witness Intimate Partner Violence (IPV) 
in their homes(1) with significant immediate and long-term consequences to physical and 
psychological health.(2, 3) Exposure to IPV perpetrated by fathers is common among children 
referred to child protective services with both national and state level data indicating between 30-
40% of child welfare reported children are exposed to IPV, which is most often perpetrated by a 
father figure.(1, 4)  Child protective service systems have long focused on mothers in their 
interventions for both safety and treatment of IPV.  Mothers have been tasked with protecting their 
children from witnessing IPV or risk losing their children. (5, 6)  Further, all the treatment 
requirements and opportunities are provided to and expected to be carried out by mothers.  
Fathers are not held accountable nor are they expected to participate in treatments often due to a 
belief that interventions do not work for this population. This belief comes from several meta-
analyses that report near zero effect sizes of current batterer group intervention programs 
(BIPs).(7-9) the only broadly available treatment for IPV perpetrators, in reducing violence. Beyond 
negligible effects, attrition rates, even for court-mandated programs, are high (30-60%) indicating 
a significant service need. Importantly, even among intervention completers, recidivism rates for 
BIPs can be 20-30% indicating high intervention failure. (10) Often, men who continue to use 
violence following completion of a group BIP are re-referred to the same program or another 
similar group program of greater length. (11)  Others may serve a short jail sentence with no other 
treatment provided.  Families with IPV are frequently involved with child protective services 
because it is well known that exposure to IPV is detrimental to children and increases their risk for 
psychosocial and psychiatric difficulties. (12-14) Despite their ineffectiveness child protective 
services and the courts in many states continue to use completion of BIPs as sufficient to grant 
child visitation or as evidence that child protective oversight is no longer needed.(15, 16)
Why focus on fatherhood to engage men?   Given the current “one size fits all” approach to 
batterer intervention has shown limited impact on the outcome of repeat violence and re-arrest,(8, 
17) there is urgent need for alternative intervention approaches. Psychoeducational group 
interventions have been the standard with the belief they are more effective for the population.  
They focus on societal influences that condone violence against women, power and control and 
teach skills for anger management.  Evidence suggests that tailoring IPV interventions specifically 
for men who are fathers may improve outcomes.(18, 19) Indeed, studies suggest fatherhood is a 
motivator for change among men who perpetrate IPV.(20, 21) Rothman and colleagues 36 found 
that nearly 2/3 of biological fathers who perpetrated IPV believed that their violence negatively 
affected their parent–child relationship and many worried about the long-term impact of IPV on 
their children. These data suggest that interventions that build on fathers’ commitment to and 
empathy for their children may be a particularly promising approach. In their study of 
interparentally violent fathers, Perel and Peled(21) concluded that most fathers desired greater 
warmth, involvement, and connection in their relationships with their children.  Other studies(18) 
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similarly revealed that men experienced shame, guilt, and remorse when thinking about the harm 
they may have inflicted upon their children and they report a wish to shield them from their 
anger.(22) There is evidence that fear of losing family relationships and worry about harm to their 
children were influential in fathers’ decisions to change their behavior and engage in 
intervention.(23) Therefore, developing IPV interventions that approach men as fathers who can 
have a positive impact on the health and development of their children rather than as “batterers” 
could be a more effective way to engage men in treatment leading to better clinical outcomes.  
Treatment engagement is the first step to intervention success.  If individuals do not attend 
treatment they cannot benefit. Following engagement, to reduce IPV and CM, an intervention 
must target an appropriate mechanism of change.  
What Intervention Mechanisms Could Reduce IPV and CM? Current Batterer Interventions 
target beliefs about the roles of women and power and control behaviors with limited impact on 
IPV.(7-9) Recent research indicates BIPs that more carefully consider psychopathology and 
psychiatric needs or incorporate mindfulness and psychological flexibility instead of power and 
control may be more effective in reducing IPV.(7, 24-26) RF describes the capacity of individuals to 
understand their own and others’ actions as a function of underlying psychological and emotional 
states and motivations.(27) Individuals with high levels of RF are better able to recognize their own 
and others’ thoughts, emotions, intentions, and desires.(27) Poor RF is associated with increased 
violent and aggressive behavior(28-30) and emotional dysregulation. Studies by the PI have 
indicated fathers with histories of IPV have very low levels of RF.(22, 31) Studies in mothers indicate 
a significant association between poor RF related to their children and maltreatment.(32, 33) While 
there is less research on the relationship between paternal RF and child maltreatment, poor RF is 
a potential core element driving male perpetrated IPV(34)  Reading of the larger literature suggests 
a common and potentially modifiable pathway to IPV and CM through RF.  Men at risk for IPV/CM 
often misperceive threat (acute threat sensitivity) especially from their partners 48 and instead 
respond to innocuous or ambiguous stimuli with hostility and emotion dysregulation and 
violence.(26, 35-41) Lack of RF is important to this chain. Poor RF can result in: 1) misperceptions of 
partners and children’s’ intentions or behaviors and 2) lack of understanding of one’s own 
emotions, triggers, thoughts, and behaviors and 3) poor regulation of emotion that can result in 
violence. The PI has demonstrated low RF in fathers with histories of IPV(22, 31) and experimental 
studies have indicated that improving emotion regulation reduces violence.(24, 25) Therefore, 
intervention like F4C that can increase RF could reduce IPV and child maltreatment.
F4C as an Intervention for IPV and CM: F4C approaches men through their roles as fathers to 
increase engagement in the RF focused work that is central to the intervention. F4C is offered 
individually by master’s level therapists to fathers with histories of IPV, defined as threatened or 
actual sexual or physical violence against an intimate partner in the past 12 months. F4C 
addresses 9 individually focused core topics, 4 co-parent topics, and 5 father-child focused topics 
in 60-minute individual therapy sessions over 26 weeks to achieve: (1) reduction of IPV and (2) 
decreased child maltreatment. In the context of a strong working alliance developed through focus 
on fatherhood,(42, 43) F4C intervention employs a continual focus on RF and emotion regulation 
skills.  Improvement in these targets in turn leads to reduced IPV and child maltreatment.  In 
concert with the IPV literature.(44, 45) F4C motivates the father to change by continually recognizing 
his desire to be a better parent and facilitating his ability to reflect on the experiences of his co-
parent and children and learn new skills to manage his own affect and thinking to improve 
outcomes for his family.  This is an innovative treatment approach that fills a significant gap in the 
field of IPV interventions. 
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Figure 1.  Working Theoretical Model of Fathers for Change 
Why design an individual approach instead of group? Although programs for both IPV and 
CM have been implemented using a group approach(8, 46-48) F4C is an individual treatment 
approach.  We chose this approach because: (1) IPV group approaches have been generally  
ineffective;(8, 9) (2) there is  evidence that antisocial individuals in a group can have a contagion 
that limits the effectiveness of the group as a whole(49, 50) and may be iatrogenic;(51) (3) 
interventions for aggressive adolescents were more effective delivered in an individual format 
compared to group;(52) (4) the therapist needs to understand each client’s own childhood history of 
exposure to violence, hostility triggers, and their intimate relationship patterns to optimally tailor 
role play, practice reflective functioning, and teach affect regulation skills; (5) our clinical 
experience with the population raises the concern that some men may be unwilling to share this 
information in group treatment; and (6) the co-parent  and father-child focused components 
require the therapist to carefully assess RF, emotion dysregulation, and communication patterns 
based on the type of prior difficulties, whether the couple is still in a relationship, and the 
developmental age of the children in order to provide appropriate support.  This is difficult in group 
treatment and does not allow for the individualized work and practice in session that is provided in 
F4C as one-on-one treatment.
Preliminary Studies F4C development.  
First, F4C(53) was developed and piloted by 
the PI in an outpatient clinic setting. A sample 
of 10 fathers were referred by child protection 
and the courts to participate in an open trial 
of initial feasibility.  Completion rates were 
80% and all fathers who completed the 
program remained non-violent during 
treatment with very high satisfaction 
indicating good potential for intervention 
acceptability.(53) Next, using content, 
treatment manuals, and training materials 
developed during the pilot study outlined 
above, Dr. Stover trained 12 clinicians in 
community mental health clinics to deliver F4C to child protection involved families through a 
statewide initiative in CT.  Based on session fidelity reviews it is clear clinicians have successfully 
implemented the intervention using the manual and training curriculum.  Based on a sample of 73 
fathers referred to F4C, 74% completed the program.  Importantly 68% of those referred to F4C 
had previously participated in a BIP.  Additionally, fathers self-reported significant improvements 
IPV
Child 
Maltreatment
Outcomes
1.  Reflective 
Functioning 
2. Emotion 
Regulation
sills
Fathers for Change
Intervention Targets 
Pre
Post
0
10
20
30
Mom's report
Dad's report
Figure 2.  Reductions in IPV Pre-Post F4C 
Treatment
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in the intervention targets of emotion regulation and reflective functioning from pre to post 
intervention (p<.05).  There were significant reductions in IPV post-intervention based on mothers 
and fathers reports(54) (see Figure 2) and significant reductions in child maltreatment risk based on 
the Parental Acceptance Rejection Questionnaire(55) (t (67) = 6.44, p < .00) These data support 
F4C’s ability to improve hypothesized intervention targets and IPV and child maltreatment 
outcomes.  The current study is needed to provide an initial randomized test of F4C compared to 
an individually delivered BIP and group BIP. The randomized three group study will allow us to 
test F4C compared to BIP-I and Group BIP (BIP-G) and indicate whether the individual treatment 
format is the driving factor OR the content OR both.  
3.
Research Plan: Summarize the study design and research procedures using non-technical language 
that can be readily understood by someone outside the discipline. If working with a Non-Government 
Organization (NGO) or other organization, be sure to highlight which are research-only activities and which 
activities would occur regardless of the research. If working with survey firms, please specify what research 
activities the research firm will be responsible for. 
Phase I:  Seventy five fathers of children aged 6 months to 11 years will be referred by the 
Department of Children and Families to the Parent and Family Development Program at Yale, 
recruited and randomized to either F4C BIP-I or BIP-G (n = 25 per group) following an initial 
screen and baseline assessment.
Phase II:  
Two hundred eighty fathers, the female coparent of their youngest child, and their youngest biological child 
aged 9 months to 12 years will participate for a total of up to 840 participants in this Phase 2 randomized 
controlled efficacy trial. 
Initial screen: 
Referred fathers will be asked to complete an initial brief screening if they are interested in 
participation in the study, which will include demographic matching information such as age, 
ethnicity, city of residence, income, employment history, substance abuse history etc. He will be 
told that his screening questionnaire will be reviewed, and he will be contacted to set up further 
assessment sessions if he is found to be eligible. This will provide the opportunity for contact with 
the mother to conduct phone screening with her related to IPV and assess her willingness for 
herself and their shared child to participate.  
Fathers will be told that their female co-parents (and if different current intimate partners of 
more than 6 months) will be contacted but they will not be told when (day or time) this will occur. 
Female co-parent contact information will be provided on the referral from DCF so that fathers are 
not providing this information, and this will limit the possibility of coercion. The phone screening 
with female co-parents will include IPV specific questions (e.g. severity of IPV and status of 
protective orders). If the father is not eligible based on screening due to severe IPV that involves 
admitted hospitalization or strangulation, or a current full protective order related to his child, he 
will be informed that he does not meet our demographic criteria based on his initial screening. No 
mention of contact with mother will be made. If the father agrees to the study and he is eligible 
following screening of his female co-parent and she agrees to participate to provide information 
about their shared child, he will schedule a time to complete the second assessment with the 
child. Fathers will be able to participate even if their co-parent refuses participation of their shared 
child as long as he meets other eligibility criteria (no severe IPV involving hospitalization, no full 
contact protective order with child, mother consents to participate in providing symptom 
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information about their shared child) to ensure there is no coercion or retaliation toward female 
co-parents for their decisions about child participation.
Baseline assessments: 
Each father who agrees to participate based on recruitment screening described above will 
be invited to a 2-hour baseline interview either in person or via a password protected Zoom meeting 
to ensure security. He will complete standardized questionnaires in interview format with a trained 
research assistant to assess (a) history and severity of IPV, (b) psychiatric symptoms, (c) self-
reported emotion dysregulation, (d) adverse childhood experiences (e) substance use (g) 
relationship status with the coparent and frequency of contact with his children and (g) reflective 
functioning (RF). We have successfully used all the included measures in prior studies with the 
target population without any adverse events. 
Fathers will also be asked to attend a second appointment with their child for a structured 
play assessment. These will take place at 350 George Street, New Havenor 65 Kane Street in West 
Hartford following all safety protocols outlined by Yale will be followed regarding COVID-19 
precautions or via a zoom video conference if in person is not feasible. The father-child play session 
takes 25 minutes and child questionnaires administered to youth 7 and older will take less than 20 
minutes..Mothers will be contacted before for consent for participation of their child and as collateral 
informants on study assessments. If indicated, current female partners will also be invited as 
collateral informants.  Mothers and female intimate partners may complete study questionnaires via 
telephone, zoom, or secure online survey link via the Yale Research Electronic Data Capture 
(REDCap). 
The second session with the father will include the target child and include self-report 
measures of symptoms for children aged 7 and up followed by free play session with their father. 
This portion will be video recorded with the father and the target child.  Fathers will be asked to play 
with their children for 15 minutes with a set of age appropriate toys. Upon completion of the play 
time they will be instructed to have their child clean up the toys.  These interactions will be video-
recorded either at the study offices or via the Zoom secure platform and coded by trained blind, 
RAs using the Child Interactive Behavior Rating Scale.  The scale has age specific coding criteria 
for infants, toddlers, preschool, and school aged children.  
The RA will complete study assessments in person or via zoom with fathers, mothers and 
partners at baseline, immediately following intervention completion, at 6 and 12 month follow-ups.  
Each measure and timing of assessment are outlined in Table 1.
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Table 1.  Assessment 
Schedule
Rater
Baseline
Weekly 
During 
Intervention
Monthly 
During 
Intervention
Post-
intervention 
6& 12 Month-
FU
IPV Outcomes
Family Socialization Interview 
Revised (FSI-R)96,108 – IPV module
Masked Coder
X
X
X
Time-line follow-back for IPV (56, 57)
Father, Mother, 
Current Intimate 
Partner 
X
Abusive Behavior Inventory (ABI)
Father, Mother, 
Current Intimate 
Partner
X
X
X
Court and Arrest Records
N/A
X
X
Child Maltreatment and Parenting 
Outcomes 
Child Protective Services Records
N/A
X
X
Family Socialization Interview 
Revised (FSI-R)96,108 – Parenting 
Risk module
Masked Coder
X
X
X
Timeline Followback-CM Risk
Father and Mother
X
Conflict Tactics Scale-Parent Child
Father and Mother
X
X
X
Father-Child Free Play coded using Child 
Interactive Behavior Rating (CIB)+
Masked Coders
X
X
X (12 month 
only)
Child Symptoms
Children’s Emotions Scale (RCES)
Mother and Father
Brief Infant Toddler Social 
Emotional Assessment (BITSEA) 
Trauma Symptom Checklist for 
Young Children (TSCYC) or 
Trauma symptom checklist for 
children (TSCC) appropriate for 
child age
Mother and Father
Children >7-Self 
Report
X
X
X
Kiddie Diagnostic Interview 
Schedule PTSD Module OR 
Diagnostic Infant and Preschool 
Assessment (DIPA) modified 
PTSD module
Mother and Father
X
X
X
Satisfaction Outcomes 
Client Satisfaction Questionnaire 8 (58)
Father
X
Intervention Targets (Mechanisms)
Unified Protocol Skill Use Scale 
(UPSUS)122 and select items from the 
28-item Brief COPE
Father
X
Difficulties in Emotion Regulation Scale (59)   
DERS Short Form
Father 
X
X
X
X
Reflective Functioning Questionnaire-8  
(RFQ)(60) 
Father
X
X
Parent Reflective Function Questionnaire 
(PRFQ) (61)
Father 
X
X
Intervention Process Variables
Working Alliance Inventory (62)
Father and Clinician
X
CHANGE Coding
Trained Reliable 
Coders
X
Motivation to Change 
Father
X
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Measures during baseline 
Child Maltreatment Risk:  We will collect official records of child maltreatment from the Department 
of Children and Families.  We will also collect logs of child maltreatment risk behaviors (harsh 
discipline and hostility toward the child) as reported on time line follow-back calendars during 
treatment.  Parents will report on their harsh/hostile behavior on the Conflict Tactics Scale-Parent 
Chlid Version. These will be used to inform masked coder ratings on the Family Socialization 
Interview (FSI-R; our primary outcome measure).  The FSI-R assesses severity of child 
maltreatment risk based on a compilation of data from self- report, collateral reports and records.   
Parent-Child Interaction Tasks.(75)  Each Father-child dyad is video-taped in a semi-structured 
20-minute play session.  It consists of 15 minutes of free-play and a 5-minute clean-up.  Each play 
session will be coded using the Child Interactive Behavior Coding(72) which has been validated with 
children aged birth to 13 years. Infant, Preschool or Child coding guidelines will be used depending 
on child age.  The following codes are used across ages: 1) parental hostility/intrusiveness, 2) 
dyadic reciprocity, and 3) child’s relationship behavior toward the parent (avoidance, anxiety).  
Parents and children will be rated by trained blind coders who have attained .75 reliability to the 
task author Ruth Feldman; 15% of the tapes will be double coded for reliability checks. The video 
recording of play assessments with the child pre and post treatment is necessary for coding father-
child interactions before and after the treatment. 
Child Mental Health. Symptom dimensions will be derived from father and mother reports on 
surveys with established reliability, validity, and developmental sensitivity. For data reduction 
purposes, continuous latent constructs will be identified via measurement models and second-
order factor models conducted in Mplus127 using standard fit criteria.128,129 If necessary, we will use 
other methods to reduce these data, e.g., latent constructs formed by principal components 
analysis. The TSCYC and TSCC includes 8 subscales assessing trauma symptoms and more 
common childhood symptoms and are used for children aged 3 to 17.  For infants and toddlers, 
we will have parents complete the Brief Infant Toddler Social Emotional Assessment (ITSEA)
Stratified Randomization.  To increase the likelihood treatment groups are balanced on important 
variables (i.e., , residence with target child, protective order with coparent,  substance use) 
participants will be assigned to treatment through stratified randomization.    Following 
randomization, fathers will be assigned to either 18 sessions (once per week) of Fathers for Change 
or18 sessions of Duluth Batterer Intervention delivered in an individual format .  We anticipate 140 
participants in each treatment group. Research assistants managing the data Dr. Sullivan will be 
blind to treatment condition assignment during analysis.  Participants will be recorded as receiving 
either “treatment 1”, or “treatment 2” . The research assistants and Dr. Sullivan will not be aware 
which treatment protocol “treatment 1” or  “treatment 2” correspond to until analyses are complete. 
Therapist Session Report Form
Clinician
X
Other variables to classify the sample 
 STRESS Trauma History and PTSD Scale
Father
X
Alcohol Use Disorders identification Test 
(AUDIT) – Self report(66) 
Father
X
Drug Abuse Screening Test- 10 (DAST-
10)(67)
Father 
X
TimeLine Follow Back-Substance Use
Father
X
X
Father Contact and Engagement Scale(68, 
69)
Father and Mother
X
X
X
Brief Symptom Inventory (BSI) (70)
Father and Mother
X
X
CoParent Relationship Scale Children’s 
Exposure to Violence Only
Father and Mother
X
X
X
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Treatment Phase. 
Each treatment will be delivered weekly over 18 weeks. Male participants will meet online 
or be contacted via phone weekly with the RA to complete self-report assessments of IPV 
behaviors, father-child interactions and substance use. The RAs will be blind to the participants’ 
treatment conditions.(79) Study therapists will complete weekly session reports of session content 
and skill acquisitions based on completed homework.
Fathers for Change:  F4C focuses on:  1) the fathering role to facilitate engagement, 2) RF 
to understand self, partner and children and emotion regulation skills to reduce IPV and child 
maltreatment(80, 81) F4C focuses on understanding of emotional experiences, how they impact 
thinking and behaviors related to partners, co-parents and children. F4C clients will meet 
individually with their F4C therapist for 50 minutes per week over 18 weeks.  
Batterer Intervention Program:(82, 83) The BIP is a psychoeducational intervention that will 
be delivered in 50- minute individual sessions over 18 weeks.  The intervention focuses on the 
impact of violence on victims, power and control tactics, and societal influences supporting men’s 
violence toward women.  The intervention includes didactics and experiential exercises including 
role 
plays 
to 
teach 
anger 
management 
skills. 
BIP is typically delivered in a group format, however will also be adapted to an individual 
format as part of the current study.   Therapies will be delivered either in person or via 
secure/password protected zoom virtual sessions.  All Yale safety protocols with regard to COVID-
19 will be followed.  
Therapist Training. Master’s level clinicians will be trained to deliver the study interventions.  Dr. 
Stover will utilize the therapist training manual, slides and videos generated from her pilot studies 
to train F4C therapists.  She will meet weekly with F4C therapists for supervision.  BIP-I and BIP-G 
therapists will be trained by Dr. Sullivan using the BIP manual(82, 83) and training materials modified 
for individual treatment delivery. BIP clinicians will meet weekly with Dr. Sullivan for supervision and 
intervention adherence.  
Treatment Fidelity.   Each intervention session will be video recorded.  Trained coders will rate 
20% of sessions for fidelity and change in emotion regulation/reflective functioning during therapy 
sessions using the F4C/BIP Fidelity Measure and the CHANGE coding system. Tape raters for 
fidelity will be trained by the PI coding a set of 6 practice tapes.  Fidelity feedback will be provided 
by Drs. Stover (F4C) and Sullivan (BIP) in their respective supervision sessions with study 
therapists to ensure fidelity and allow corrective feedback. Tape raters will be trained by Adele 
Hayes for the CHANGE session coding system and will be supervised by Dr. Hayes at the 
University of Delaware and Dr. Grasso at the University of Connecticut.  The Change and Growth 
Experiences Scale (CHANGE; Hayes, Feldman, & Goldfried, 2007) is an observational coding 
system that assesses processes of change during psychotherapy, including factors that facilitate 
and inhibit therapeutic change. The CHANGE has been used to code audio and video recordings 
of sessions or narratives from clinical trials of trauma-focused cognitive behavioral therapy (TF-
CBT) for youth (Alpert et al., 2021; Canale et al., 2021; Ready et al., 2015; Yasinski et al., 2016), 
prolonged exposure, written exposure therapy (WET), and cognitive processing therapy (CPT) for 
adult PTSD (Alpert, 2021; Alpert et al., 2020; Sloan et al., 2021), as well as cognitive-behavioral 
treatments for depression (Abel et al., 2016; Adler et al., 2013; Hayes, Feldman, Beevers et al., 
2007; Yasinski et al., 2020) and personality disorders (Hayes & Yasinski, 2015). The CHANGE 
has been used to identify key predictors of treatment dropout and outcomes in each of these 
clinical trials. 
Weekly and Monthly Measures During Treatment
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The RA will meet with fathers via password protected zoom link or in person to complete logs of 
IPV, substance use and interactions with their children and monthly assessments of working 
alliance and treatment motivation via computerized survey at the time of their weekly clinical 
appointment. If fathers do not show for their appointment RAs will phone him to collect the 
information or email a secure survey. All data will be entered into a secure web-based REDCap 
database.  
TimeLine Follow-back-Spousal Violence, Child Maltreatment Risk, & Substance Use (TLFB-
SV/SU/CM)(57) will be used to assess specific types of IPV (physical, sexual, psychological) toward 
partners on any given day,  contact with the target child and child maltreatment risk behaviors 
(yelling, swearing, spanking, slapping, ignoring, harsh punishment). The TLFB-SV/SU/CM will be 
administered weekly to assess violence, substance use and CM risk behaviors during treatment. 
This is a reliable and valid instrument that has been used to assess relationship violence over time 
and links to substance use. (57) Participants, the mother of their youngest child and if different their 
current female partner will be asked to report IPV and CM throughout treatment.
Measures of Treatment Targets:  Fathers will complete items from the Parental Acceptance 
Rejection Questionnaire, COPES and Unified Protocol Skill Use Scale to assess intervention coping 
skill use and emotion regulation/RF changes during treatment.  
Measures of Treatment Process:   Fathers will complete the Working Alliance Inventory, (84) 
Motivation to Change (85) on a monthly basis and the Client Satisfaction Questionnaire at the 
end of treatment(86) to document (a) the quality of their relationship with their clinician, (b) their 
perceived motivation for change, and (c) satisfaction with treatment.
Post intervention: 
Follow-up interviews will be conducted post-treatment to assess changes in IPV, child maltreatment 
risk, and child mental health. This will also be done via zoom or in person. Fathers will be offered 
$60 for post-treatment assessments and mothers $35. These will include the same assessments 
of reflective functioning, emotion dysregulation, IPV, and child maltreatment risk administered at 
baseline. Father-child interactions will be assessed via a coded free-play interaction with the target 
child at baseline and post-treatment. Fathers will be recorded playing with their children with an age 
appropriate set of pretend play toys for 15 minutes and then during cleanup time.
Follow-up:
6 and 12 months post-intervention, fathers and coparents will participate in follow-up interviews to 
assess IPV, child maltreatment risk, father engagement and parenting.  Participants will complete 
these interviews over zoom or telephone. They will be paid $50 and mothers $35. 
Analytic Plan. 
We will use Research Electronic Data Capture (REDCap™), a widely used secure web-based 
software package designed for clinical trials(87) to collect study data. 
Preliminary Analysis:  A series of preliminary analyses will be conducted to: (1) characterize the 
sample, (2) document the internal reliability of measures, (3) check for logical consistency among 
related variables, (4) identify outlying values that should be considered for truncation, and (5) 
assess whether there are significant differences in outcomes based on study therapist.  Although 
urn randomization procedures will be used to balance distribution of specific characteristics across 
treatment groups, we will explore between-group differences in urn variables and other 
demographics and possible moderators. Data analyses will be done independently and without 
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knowledge of group assignment, with the participant’s group assignment anonymized to “treatment 
1” or “treatment 2”. 
Phase I  Hypotheses:
i.
Fathers randomized to F4C will have higher completion rates than those in the BIP-I or 
BIP-G treatment. Chi-square analysis will be used to examine between group differences 
in treatment completion.
ii.
Fathers will report greater working alliance and satisfaction with F4C than BIP-I or BIP-G.   
Analysis of variance will be used to test between group differences in working alliance and 
client satisfaction.
iii. Fathers receiving F4C will evidence greater improvement in RF and emotion regulation, 
IPV, and child maltreatment(CM) compared with fathers receiving BIP-I or BIP-G post-
intervention. Mixed effects regression will be used to test for between-group differences in 
RF, emotion regulation, IPV, and CM representing treatment effects associated with F4C 
versus BIP over time.  Separate IPV and CM sum scores will be created. Any instance of 
IPV or CM by any report (self, co-parent or current partner report on the Timeline Follow 
Back, child protection or arrest records) will be counted to create a sum score across 
reports.  The Child Interactive Behavior Codes(75) of Intrusiveness and Child Avoidance will 
be used as our observational measures of CM risk. Total coded RF score as measured by 
the PDI and self-reported emotion regulation on the DERS will be used to test impact 
mechanisms of F4C.
iv. Exploratory hypothesis: Test whether improved RF and emotion regulation are associated 
with reduced IPV and CM consistent with the F4C mechanisms of change. We will test path 
models: treatment group (dummy coded F4C, BIP-I or BIP-G) to each mediator (RF, emotion 
regulation) to the two outcomes (IPV and CM). See Statistical Analysis section for further 
details.  
Power Analysis:  A sample of 75 with planned 63 participants with complete data will provide 80% 
power to detect group differences with a modest effect size of .45 (see Statistical Design and 
Power Section).
Phase II Hypotheses:  
AIM 1 Hypotheses: Children of fathers who receive F4C (n=180), relative to BIP (n=180), will: 
(1a) experience less family violence (FV), (1b) have more positive father-child interactions, and 
(1c) have lower FV-related mental health symptoms (PTSD, internalizing/externalizing) at post 
treatment and 6- and 12-month follow-ups. The effects of both treatments on father and coparent 
mental health outcomes will also be examined (1d exploratory). Hypotheses will be evaluated with 
the broad family of latent (growth) curve models (LGM),138 which estimate and compare 
trajectories of change for each case in the data. Group differences in changes will be tested in 
multiple group LGM models.139 Following analyses for our primary study hypotheses, we will 
examine whether child sex moderates child mental health outcomes between the F4C and BIP 
groups. Power. The planned sample size of 140 F4C and 140 BIP cases provides power of .91 to 
detect a small to moderate effect size (d = 0.12). The current study with 140 per group (even 126 
per group assuming a conservative 30% attrition at follow-up) has sufficient power to determine 
small differences in changes between intervention groups on outcomes. LGM models for changes 
in latent rather than observed scores, for three or more waves of data, have the advantage of 
partialing out measurement error, and increasing the statistical power by at least 20%.140 See 
Statistical Design and Power Section for estimation method. 
AIM 2 Hypotheses. Compared to BIP, more F4C fathers will show profiles of healthy change in 
therapeutic targets: (2a) masked coding of in-session RF/ ER (i.e., increased RF and adaptive 
ER, decreased maladaptive ER), and (2b) between-session self-reported RF/ ER (i.e., increased 
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RF and adaptive ER, decreased maladaptive ER). F4C change profiles will reveal critical 
junctures in treatment that precipitate therapeutic change, thereby serving to optimize timing and 
delivery of treatment components (2c, exploratory). Group-based trajectory modeling from the 
family of latent growth mixture modeling (GMM)141 will be used first to examine the number of 
different trajectory groups and their profiles (e.g., stable low or high adaptative ER, gradual 
increase or decrease in RF level, initial increase, then stable RF level, rapid decrease followed by 
gradual decrease of maladaptive ER, etc.) during the intervention period, as well as determine 
whether F4C vs. BIP treatment conditions influence trajectory group membership. Initially, 
trajectories of each in-session and between-session therapeutic change target will be modeled 
separately. Because data are expected to have unequal measurement intervals, we will use a 
new feature in Mplus 8.8 for analyzing such data (i.e., tinterval and dynamical SEM142), and 
explore a new Stata 17 module for irregular time spacing measurements (i.e., xtusreg).143 
Subsequent models will simultaneously examine various combinations of these six related targets 
to identify appropriate group membership for the fathers. This therapeutic change grouping will be 
modeled as the mediating variable in subsequent mediation analyses. Power. Determining power 
in group-based trajectory modeling with unequal time gaps is complex and not well explored. 
Given that some applications have used the classical, similar analytic method, mixture LGM (with 
equal time gaps), to extract three classes with a sample size as low as 45,144 the current target 
sample size of 360 (or 252 with attrition) will be adequate to identify trajectory groups and test 
further differences between F4C and BIP groups.  
AIM 3. Hypotheses. Profiles of healthy change in RF and ER will mediate the treatment effect of 
F4C over BIP on: (3a) FV (3b) father-child interactions, and (3c) child mental health (PTSD, 
internalizing/externalizing) at post-treatment and at 6- and 12-month follow-ups. LGM mediation 
models will be used to evaluate the mediating effect of therapeutic change classes on the 
treatment impact on both the fathers’ use of FV and children’s outcomes. In particular, the 
baseline predictor will be father’s randomly assigned intervention group: F4C vs. BIP, with father’s 
therapeutic change in RF and ER trajectory groups from Aim 2 entered as a categorical mediator 
into a structural equation model framework to investigate the mechanisms of change in child 
outcomes at post-intervention and up to two subsequent follow-ups. Power. Power analyses for 
mediational LGM models with categorical mediators are rare.145 The specialized Mplus 8.8 SEM 
software however has been advancing the toolbox available for such complex models, and its 
recent capabilities promise to provide adequate statistical power with the proposed sample 
size.146
4.
Participant Population: Provide a detailed description of the types of participants who will be 
recruited into this study. 
Phase I:
Seventy-five fathers of a biological child between 6 months and 11 years who are referred 
by the Department of Children and Families due to use of domestic violence in the last 12 months, 
the female co-parent of their youngest child and if different their current female intimate partners 
of more than 6 months, and their youngest biological child aged 6 months to11 years will 
participate for a total of up to 240 participants in this Phase 1B randomized controlled trial.
Female intimate partners who are not the co-parent of the youngest child will be contacted 
if they have been in a relationship with the father for at least 6 months at the time of consent. 
Phase II:
The target sample is 280 father-coparent dyads and their 9 months to 11 year-old children 
recruited from CPS-involved families referred to the Parent and Family Development Program 
(PFDP) at Yale or the UCONN Health Center Outpatient Psychiatry Clinic. Participants will be 
randomized to either F4C (n = 140) or BIP (n = 140) following a baseline assessment. Half of F4C 
and BIP families will be treated at Yale and half at UConn Health. Yale will serve families in 
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Greater New Haven region, while UConn Health will serve families in the Greater Hartford region. 
The two sites are approximately a 45-minute drive apart. 
5.
Describe how access to the population will be gained in the study. 
Fathers referred to the Parent and Family Development Program or UCONN Health Center 
by the CT Department of Children and Families (DCF) or the community due to IPV or child 
maltreatment risk will be provided information about the study and asked to complete an initial brief 
screening if they are interested in participation. He will be told that his screening questionnaire 
(which will include demographic matching information such as age, ethnicity, city of residence, 
income, employment history, SA history etc.) will be reviewed and he will be contacted to set up 
further assessment sessions if he is found eligible by the PI based on our study’s requirements. 
This will provide the opportunity for contact with the mother to conduct phone screening with her 
related to IPV and her willingness for their shared child to participate.  Female co-parent and 
intimate partner contact information will be provided on the referral from DCF or community referral 
source so that fathers are not providing this information, and this will limit the possibility of coercion.
6.
Participant classification: Check off all classifications of participants that will be specifically recruited 
for enrollment in the research project. Will participants who may require additional safeguards or other 
considerations be enrolled in the study? If so, identify the population of participants requiring special 
safeguards and provide a justification for their involvement.
☒ Children
☒ Healthy 
☐Fetal material, placenta, or dead fetus
☐Non-English Speaking
☐ Prisoners
☐Economically disadvantaged persons
☐Decisionally Impaired
☐ Employees
☐Pregnant women and/or fetuses
☐Yale Students 
☐ Females of childbearing potential
 Click or tap here to enter text.
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
participants? ☒Yes  ☐ No 
It is possible that the children of some enrolled fathers will be placed in foster care and under the 
guardianship of the Department of children and families at the time of referral.  These children 
would only be enrolled if there was planned reunification with the father.  
7.
Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion or    
exclusion? 
Inclusion Criteria.  Men who (1) report an incident of IPV (pushing, slapping, kicking) within the 
last 12 months prior to screening (based on court/police records, partner or self- report); (2) have 
at least one biological child aged 9 months to 12 years with whom they have contact in person or 
by phone/facetime etc. at least monthly; (3) are able to complete assessments in English; and (4) 
agree to have their female coparents (mother of the youngest child) contacted as collateral 
informants and for consent for participation of their shared child.  If a participant has more than 
one child in the age range, the youngest will be the target of assessment. Female coparents (the 
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target child’s biological mother who does not need to be in a relationship with the father at the 
time of the study) will be contacted to consent for participation of herself and their shared child.  If 
the coparent declines participation of the child the father may still participate in the study if he 
meets eligibility criteria to prevent any possible retaliation against co-parents for not consenting to 
child participation.  No information about contact with co-parents or their responses will be 
provided to the fathers 
Exclusion Criteria.  Men will be excluded who have: 1) an active full/no contact protective order 
pertaining to their child since this will preclude participation in the father-child play assessment 
(many men will have full no-contact orders with their partners, but it is more common for men to 
still be allowed at least supervised contact with their children even with a full/no contact order with 
their partner); 2) physiological addiction to a substance that requires detoxification.  Fathers will 
be evaluated using the AUDIT and DAST .  If fathers report difficulties with physiological 
withdrawal from substances (e.g. delirium tremens, shaking, nausea) they will be referred for 
detox services.  They can be re-evaluated following a detox program with documentation from the 
detox center of successful completion and clean urine screen.; 3) cognitive impairment that will 
not allow for understanding of the study interventions (a mini mental state score <25); 4) current 
untreated psychotic disorder;  5) currently suicidal or homicidal based on screening using the BSI; 
6) Are currently enrolled or have previously received F4C or BIP; 7)coparent declines to provide 
collateral information about their child’s symptoms.
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 
1.
Recruitment Procedures: 
a. Describe how potential participants will be identified and contacted, and by whom.
Fathers will be provided information about the study at the time of referral by DCF to the 
Parent & Family Development Program at Yale or the UCONN Health Center.  Contact 
information for co-parents will be provided by DCF  or other referral sourc at the time of the 
referral (which is current practice).  Each father will be recruited and given initial screening by a 
study RA in person or over the phone.  If a father expresses interest, an in-person or virtual Zoom 
appointment will be scheduled to complete informed consent and baseline measures.  
  Mothers of the fathers’ youngest child will be contacted for initial screening and to assess 
her willingness to allow participation of herself and their shared child in the study.
All research staff reaching out to female co-parents or current intimate partners will be trained on 
phone recruitment strategies used in previous studies by the PI and others to ensure safety of 
victims of IPV. These include: 1) asking whether she is free to talk now: 2) asking if it is ok to call 
back again; 3) asking if it is safe to leave messages on her voicemail or via text; and 4) during 
informed consent, making a plan for the safest way to contact her for follow-up data collection 
throughout treatment.
  Mothers will be interviewed via zoom or in person on different days and encouraged to 
ensure their safety by choosing a location where they feel safe and away from the father to take the 
call. Fathers will not be informed of mothers’ agreement to participate or the time or location of any 
contact the study team has with them.  They will complete baseline interviews about their 
relationship history with the father, IPV in the relationship and the father’s child maltreatment risk 
behaviors (hostility, yelling, spanking) toward the child.  Mothers and intimate partner baseline 
interviews will take approximately 1-1 1/2to complete Mothers will be offered $50 for completion of 
baseline interviews.
Dr. Stover will not be involved in the consent, recruitment, or enrollment of participants. 
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Are you collecting any information about the individuals prior to their signing a consent form? 
Yes ☒     No ☐
If yes, indicate what information you will be collecting and how it will be gathered (phone screen, paper 
questionnaire, etc.) 
An initial screen will be done with both Father and his co-parent. The RA will administer 
initial screen to father and co-parent either over the phone, in person or via Zoom. Fathers screen 
will include demographic matching information such as age, ethnicity, city of residence, income, 
employment history, substance abuse history etc. Co-parent screen will include IPV specific 
questions (e.g. severity of IPV and status of protective orders) 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used.
☐Flyers
☐ Internet/web postings
☐ Radio
☐ Posters
☐ Mass email solicitation
☐ Telephone
☐ Letter
☐ Departmental/Center website
☐ Television
☐ Through local NGO or other local contact
☐ Departmental/Center research boards
☐ Newspaper
☐ Table set-up / in-person recruitment of public   ☐ Snowball sampling
☐ Classroom recruitment
☐ Social Media (Twitter/Facebook): 
☒ Other: Referral by DCF case workers or IPV 
specialists
3. Targeted Enrollment: Give the number of participants:
a.
  Targeted for enrollment at Yale for this protocol: Phase I: 180 Phase II:  (180 fathers, 180 
coparents and 180 children) =540
b.
If this is a multi-site study, give the total number of participants targeted across all sites 
(280 fathers, 280 coparents and 280 children) = 840
4.  How was this estimate derived?  
Phase I:  Seventy-five fathers, the female co-parent of their youngest child, and their child will 
participate for a total of up to 225 participants. We intend to include all 75 fathers assigned to study 
interventions for intent to treat analysis. The planned sample size of 75 participants who will provide 
data for inclusion in our intention-to-treat analysis should provide sufficient power to detect clinically 
meaningful differences between and within treatment conditions as specified in our primary aims. 
A sample of 63 people provides power of 80% to detect a standardized treatment group differences 
at 18 weeks of d = 0.45. For purposes of power estimates, we assumed d = 0.45 will represent a 
potentially meaningful clinical difference in both our primary and mechanism outcomes. In a pilot 
study examining F4C on participant IPV effect size for outcome was d = 0.86.  We will enroll 75 
participants to accommodate a 16% loss to follow-up.
Phase II:  
Using these procedures in prior studies, our rate of successful follow-up has ranged from 70-90%. 
With 280 participant families randomized and an aim of at least 70% completion, we expect to 
have 196 cases with complete treatment and follow-up data.
4.
Process of Consent/Assent (NOTE: When a study includes minors, parent provide permission [not 
consent] for the child’s participation, and the child provides assent for participation)
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Describe the setting and conditions under which consent/assent will be obtained, including parental 
permission or surrogate permission and the steps taken to ensure participants’ independent decision-
making. 
Fathers will complete informed consent either in person or online via Yale’s REDcap data 
system, in line with guidance on obtaining informed consent during the COVID-19 pandemic.  
Each will agree to have their female co-parent contacted for consent of participation of their 
shared child. 
Mothers will complete informed consent related to their own participation and the 
participation of children in which they are the primary guardian. This will be completed online via 
Yale’s REDcap system..
Children in the study will be up to age 12 so will not sign informed consent but an assent 
will be used.  For children under the age of 7 a verbal assent only will collected. The study 
procedures will be explained to them and their verbal assent to participate in play with their dads 
will take place prior to beginning the play assessment. Children 7 and older will complete a signed 
assent.  
5.
Evaluation of Participant(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential participant’s ability and capacity to consent to the 
research being proposed, if applicable.
All potential participants (mothers, and fathers) will receive an explanation of the study, 
risks, benefits, and procedures with a trained research assistant in an individual, secure online 
Zoom meeting or in person. Research assistants who are attaining consents will be trained by the 
PIs. This will include observing Dr. Stover conducting practice informed consent procedures and 
then conducting the procedures in role play with them for practice. Participants will be asked to 
sign the compound consent form in person or via Yale REDcap, if they wish to participate 
following resolution of any questions and clear indication that the participants understand the 
nature of the study and the consent. We routinely use an informed consent quiz to assure all 
prospective participants understand all aspects of the protocol and its requirements. Fathers will 
have study interventions explained and options for participation explained. Fathers’ treatment at 
the PDFP,  or other treatments offered by the CT Department of Children and Families will in no 
way be influenced by their participation in the study. If they opt not to participate or decide to 
withdraw, they will continue to receive care as usual. The certificate of confidentiality will ensure 
that information collected as part of the research evaluation cannot be subpoenaed. This detail 
will be explained to participants and be part of the informed consent quiz to ensure understanding 
by participants.  
Children will be recruited into this study to participate in brief self-reports of their symptoms 
(for those 7 and older) and father-child observational assessments.  This will provide an 
observational measure of father-child interactions providing an additional measure of change 
related to parenting and child maltreatment risk.  Fathers will be able to participate without their 
children to reduce any risks to the children for retaliation for their lack of participation.  Study 
research assistants will describe the study procedures to the child and ask if they would like to 
participate. Verbal agreement to participate and behavioral compliance without undue pressure 
from the father will be taken as assent from children under 7. For those over 7 a written assent will 
be collected.  If a play session cannot begin or must be ended, father and child will be compensated 
for the attempt to provide data to minimize risk to the child for being uncooperative.  If a play session 
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or child report assessment does not proceed, the father will continue in the study to randomization 
and treatment assignment.  
6.
Documentation of Consent/Assent: Specify the documents or verbal scripts that will be used during 
the consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given or spoken to participants. 
A script to introduce the play assessment to children is included with the protocol.  RAs will use 
this script with children prior to beginning the sessions.
7.
Non-English Speaking Participants: Explain provisions in place to ensure comprehension for 
research involving non-English speaking participants. Translated copies of all consent materials must be 
submitted for approval prior to use. Do you speak the local language? Will you require a translator? (If so, 
please elaborate on how the translators will be trained).
N/A this study will include English speaking only participants.  
8.
Are any of the study procedures likely to yield information subject to mandatory reporting 
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -incidents of child 
abuse, elderly abuse, etc.). Please verify to whom such instances will need to be reported. 
It is possible that procedures will result in information subject to mandatory reporting of child 
abuse or harm to self or others. Participants will clearly be informed of the limits of this 
confidentiality, which are in cases of suspected child abuse or neglect, and imminent risk for harm 
to self or others (particularly intimate partner or child).
Confidentiality regulations and limits to these regulations will be adhered to as follows: The 
MPIs, along with co-investigators Sullivan, Silverman and  have extensive experience in directing 
and running clinical programs. All five investigators are licensed clinical psychologists who are 
mandated reporters and are required to report child abuse as required by law. They are also 
required to break confidentiality regulations in the event a participant is suicidal or homicidal.
Report of Suspected Child Abuse and Neglect: 
If a participant discloses abuse of a child to the research assistant during a research interview, 
he/she will immediately contact the PI at their site (or co-investigators in her absence) who will 
facilitate calling the CT Child Protective Services Hotline and writing a written report to be filed 
within the guidelines for reporting in the State of CT. This would include information about neglect, 
physical, sexual or psychological abuse of a child. Fathers self-reports of child maltreatment risk 
behavior will be monitored carefully for evidence of behaviors that reach the level of reportable 
child abuse.  Incidents of yelling or spanking may not rise to the level of a child abuse report 
based on CT law.  Further, CT law does not require reporting of IPV to child protective services, 
unless the IPV incident described included the child. Men reporting about their past incidents of 
IPV will not alone trigger a child protective services report. Reports of new incidents of IPV or 
child maltreatment risk behaviors during the course of the study will be assessed to determine if 
they meet the child abuse reporting laws outline by CT statute. In all cases of new disclosures of 
abuse, reports will be filed with protective services.  We will provide support to the father following 
the report through his assigned clinician or through other services available at the PFDP, or in the 
community.  What data are available suggest that sensitive mandated reporting of potential child 
abuse and neglect does not necessarily threaten the integrity of recruitment or participation 
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Suicidal or Homicidal Ideation or Intent: 
Upon report of suicidal intentions or the threat of harm to others, the participant will be secured to 
a higher level of treatment (e.g. hospital setting) while the female participant will be notified for her 
safety if necessary (e.g., as in a Tarisoff report, if her safety is threatened). Our team has 
expertise in dealing with high-risk behaviors and abides by all state and federal regulations. If a 
research assistant learns of homicidal or suicidal ideation or intent, they will immediately contact 
the PI at their site who will assess the participant and facilitate a higher level of care if needed. 
Drs. Stover are licensed clinical psychologists in the state of CT as are Drs. Sullivan, Silverman 
9.
Waiver of Consent/Documentation of Consent: In certain circumstances, the IRB may grant a 
waiver of documentation of consent, or a full waiver of consent, depending on the study. If you will request 
either a waiver of consent, or a waiver of signed consent for this study, complete the appropriate section 
below.  
☐Not Requesting any consent waivers 
☐Requesting a waiver of signed consent (e.g., verbal or online consent only):
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply 
to recruitment activities only)
☐ Entire Study (Note that an information sheet may be required.)
 For a waiver of signed consent, address the following:

Would the signed consent form be the only record linking the subject and the research?  YES ☒  NO 
☐ 

Does a breach of confidentiality constitute the principal risk to subjects? YES ☒  NO ☐
 
OR

Does the research pose greater than minimal risk? YES ☐    NO☐ 

Does the research include any activities that would require signed consent in a non-research context? 
YES ☐   NO ☐
 
☐ Requesting a waiver of consent (if you are not obtaining ANY consent):
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only)
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☐ Entire Study 
For a waiver of consent, please address all of the following:

Does the research pose greater than minimal risk to subjects?  
☐ Yes   If you answered yes, stop. A waiver cannot be granted.  
☒ No

Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☒

Why would the research be impracticable to conduct without the waiver? 
Conducting a full informed consent on any possible participant who comes into the PDFP without 
assessing their eligibility will put undue burden on clinic and study staff and participants. Informed 
consent for this study will take time to ensure clients understand procedures and to complete the 
informed consent quiz.  Doing this with ineligible clients is burdensome for all involved and may be 
annoying for clients who are then ineligible.  

Where appropriate, how will pertinent information be returned to, or shared with subjects at a later 
date? If the father is not eligible based on screening due to severe IPV that involves 
hospitalization or strangulation, or a current full protective order related to his child, he will be 
informed that he does not meet our demographic criteria based on his initial screening. No 
mention of contact will mother will be made.  The study team will retain de-identified 
information about clients screened and reason for ineligibility for Consort Diagram purposes 
but no information about individual clients will be retained. Screening forms will be shredded 
as soon as fathers are notified of their ineligibility or if they decline participation in the study 
following informed consent.
10. Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical 
relationship with any potential subject? 
☐Yes, all subjects
☐Yes, some of the subjects
☒No
If yes, describe the nature of this relationship. Write here
11.
Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA 
Authorization for either the entire study, or for recruitment purposes only.  Note: if you are 
collecting PHI as part of a phone or email screen, you must request a HIPAA waiver for recruitment 
purposes.)
Choose one: 
☐ For entire study 
☒ For recruitment/screening purposes only
☐ For inclusion of non-English speaking subject if short form is being used and there is no 
translated HIPAA research authorization form available on the University’s HIPAA website at 
hipaa.yale.edu.
i.
Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data: We will be contacting participants by phone to provide 
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information about the study and screen for eligibility. Conducting full HIPAA 
authorization to ask clients screening questions would be impractical to conduct and 
collect during the screening process.  
ii.
If requesting a waiver of signed authorization, describe why it would be impracticable to 
obtain the subject’s signed authorization for use/disclosure of this data: Write here
The investigator assures that the protected health information for which a Waiver of 
Authorization has been requested will not be reused or disclosed to any person or entity 
other than those listed in this application, except as required by law, for authorized 
oversight of this research study, or as specifically approved for use in another study by an 
IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of 
the Yale HIPAA-Covered entity must be accounted for in the “accounting for disclosures 
log”, by subject name, purpose, date, recipients, and a description of information 
provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer.
 
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS
1.
Confidentiality & Security of Data: Describe the steps that will be taken to secure the data during 
storage, use and transmission as outlined in the below sections.  NOTE: Data can include paper files, data 
on the internet or websites, computer files, audio/video files, photographs, etc. and should be considered 
in the responses to the below sections.
 
Confidentiality with regard to completed research forms will be maintained via a numbered 
reference system maintained by the PI and Project Directors. Participants’ names will appear only 
on the consent form, HIPPA authorization form, and “key” form in a password protected file only 
assessable by the PI.  All data will be identified by participant ID only.  All measures, video and 
recordings will be labeled by participant ID only. Subjects who decline participation in the study or 
those who wish to withdraw from the study can continue in their treatment at the outpatient facilities 
as they would if they were not approached to participate in a study. As stated above to further 
protect against potential risks to confidentiality for this population, a Certificate of Confidentiality will 
be obtained. Participants will clearly be informed of the limits of this confidentiality, which are in 
cases of suspected child abuse or neglect, and imminent risk for harm to self or others (particularly 
intimate partner or child).
Therapy sessions will be video recorded to ensure that the therapists administer the study 
treatments within manual guidelines and are engaging the intervention targets of emotion regulation 
and reflective functioning. To assure the confidentiality and protection of participants with respect 
to video and audio recording, the following steps will be taken:

Participants have the right to refuse recording. Participants who consent to recording 
will be informed that they have the right to stop at any time during any session.

Each therapist will conduct the recording him/herself. All recording will take place in 
the treatment facility in private offices.

During treatment sessions the therapist’s behavior is of primary interest for process 
assessment, the camera will be directed at the therapist.
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
Each digital recording will be labeled with the participant’s study identification 
number and a coded session date.

The therapist or RA will then store the digital recording on a password protected 
server. Yale utilizes a HIPAA compliant, encrypted and fire wall protected server 
called One Drive.  Once the files are uploaded onto the One Drive server, the session 
will be deleted from the video camera data cards.  

Access to the recordings will be limited to specially trained research raters who will 
rate the tapes according to established process rating systems. All ratings will be 
done in  esearch offices at Yale, UCONN or U of Delaware.

Upon completion of these ratings, the recordings will be deleted.
Aside from video recordings of sessions, all other study data will be de-identified and stored 
within the REDCap database.  Consent forms and releases of information for the study will be kept 
in a secure file on a password protected computer.  
The treatments provided could be an option for mandated treatment.  If clients wish their study 
therapist to provide information to court support services or some other entity related to their 
participation in treatment, the study therapist and/or PI will do so with a signed release from the 
client.  A form letter will be created that indicates the dates of program attendance, nature of the 
treatment being provided and completion of treatment.  No information about the research data 
collected or study components will be provided only their attendance and successful or 
unsuccessful completion of treatment.  If a client wishes for other information to be disclosed, they 
can indicate this on the release form.  
Criminal and child protection records will be collected by providing an excel sheet with participant 
names and dates of birth to the Court Support Services Division of the State of CT and the 
Department of Children and Families along with signed releases of information from participants 
to provide their names to the agency to provide data to us.  We will provide no other information to 
DCF or CSSD about the participants.  Data will be entered into the excel sheets by CSSD or DCF 
staff and returned to the project director.  These will be transferred from the agency to the project 
director using secure data transfer (OneDrive).  
2.
What participant information will you be collecting? Describe the identifiers that will be included or 
associated with the data and/or specimens (e.g., names, addresses, telephone/fax numbers, email 
addresses, dates (date of birth, admission/discharge dates, etc.), medical record numbers, social security 
numbers, health plan beneficiary numbers, etc.)
We will collect names, birth dates, criminal records, Department of Children and Families records 
and contact information (phone numbers, addresses and email addresses) from study participants. 
If a participant drops out of the research study we will make efforts to retain them in the study for 
intent to treat analysis. This information will be kept with the signed informed consent in a locked 
cabinet in the PI’s office. It will not be linked to study measures which will be locked in another 
office space under the participants study ID number. 
Other potentially identifying information to be collected:
☒Audiotapes
☒Videotapes
☐Faces (focus groups, photographs or other way that an individual would be physically recognized)
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☒Potential for identification from the bulk of the information, even if direct identifiers are not collected 
(deductive disclosure).
3.
How will the research data be collected and recorded? 
Data will be collected via interview and entered directly into an on-line REDCap data 
system.  REDCap is an on-line, secure data capture.  Responses to the PDI will be recorded via 
audio recorders. They will be downloaded onto a secure password protected servers that only 
study team members will have access. Digital recordings will be conducted by the therapist and 
stored on a HIPAA secure server. They will be rated by trained therapy fidelity coders. All data will 
be stored on a password protected and encrypted HIPAA compliant server at the Yale School of 
Medicine and entered on a secure REDCap database. 
Collection of records from DCF and criminal records:  Fathers will sign a release of 
information for collection of data from DCF related to his arrests for family violence related incidents 
and reports of IPV and child maltreatment to DCF.  An excel spread sheet will be created that will 
include the names of study participants and their dates of birth.  These will be sent to the contact 
person at DCF who will search records via a secure data transfer (encrypted and firewall protected 
using Yale’s secure file transfer).  The contact person who will be a state employee with approved 
access to the DCF and state arrest databases will search the names and dates of birth.  The state 
employee will fill in the excel spread sheet with the data requested (number of reports to DCF for 
IPV and CM over the 26 weeks of treatment and number of IPV or CM related arrests over the 26 
weeks of treatment).  If an incident appears in both databases this will be noted to prevent double 
counting of a single incident of IPV multiple times due to reporting to both the police and DCF.   The 
completed dataset will be returned to Dr. Stover via the same Yale secure file transfer.  DCF will 
not keep any records of this data once transferred back to Dr. Stover.  The excel sheet will then be 
updated by Dr. Stover with participant study ID numbers and the names and dates of birth will be 
deleted from the file.  This ID only dataset will be saved for merging with other study data for 
analysis.  This will ensure that arrest and DCF data will not be attached to participant names once 
it returns to Yale.  The data will be stored on a password protected server only assessible by the 
study team.    
4.
If identifiers will be associated with the data and/or specimens, describe whether a record or list 
containing a code (i.e., code number, pseudonyms) will be used, where the list will be stored, who will have 
access to the list and when it will be destroyed. 
The only file that will link the study participants to their study ID number will be an excel file kept 
on a password protected and encrypted computer in the PI’s research lab. Only the PI and study 
RAs will have access to this file.
5.
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) and/or 
specimens will be stored. Study data will be retained for 10 years from study completion to 
allow for analysis and use of data to answer research questions and the development of 
F4C.  Video and Audio recordings of fathers sessions will be destroyed based on their 
wishes at the time of consent.  If fathers will allow us to retrain their videos for training or 
research, these will be kept indefinitely. Using these videos for training purposes has been 
useful previously to train clinicians.  Fathers will be reminded that their videos will be 
kept indefinitely at the time of recording. The fathers will not be identified in the videos as 
IPV offenders. They appear as fathers interacting with their children only.  If fathers want 
their video and audio recordings deleted at the completion of the study, these will be 
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deleted from all servers following fidelity coding of session videos/supervision and 
following transcription of audio files for analysis.
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical 
reason a device cannot be encrypted please submit an exception request to the Information Security, Policy 
and Compliance Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu 
 
6.
Identify who will have access to the data and/or specimens. If the data and/or specimens will be 
transferred to and/or from outside collaborators, identify the collaborator to whom the data and/or 
specimens will be transferred and how the data and/or specimens will be transferred.   
Only study team members will have access to the data.  Dr. Adele Hayes  will have access to 
video recorded sessions stored on a One Drive folder.  They will oversee trained coders who 
will rate therapy sessions for focus on emotion regulation and reflective functioning important 
to the intervention. They will access recordings on this server. They will not be removed from 
this server at any time nor shared with others via download.  Dr. Hayes has received IRB 
exemption from her university IRB for this work.  Letters to this regard are uploaded with this 
protocol.
7.
What will be done with the data when the research is completed? Are there plans to destroy the 
identifiable data or the link to personal identifiers? If yes, describe how, by whom and when identifiers will 
be destroyed. If no, describe how the data and/or identifiers will be secured. The data will be stored in a 
de-identified dataset on the Yale secure server. Only Drs. Stover, their research team will have access 
to the data.  No personal identifiers will be retained.  
8.
Will a Certificate of Confidentiality be needed? (See also the NIH Certificate of Confidentiality Kiosk, 
http://grants.nih.gov/grants/policy/coc/index.htm) Yes a certificate of confidentiality will be attained 
from NICHD which is now standard for studies that involve collection of information that 
participants may not want disclosed to the court.  
SECTION VII: POTENTIAL RISKS AND BENEFITS
1.
Risks: Describe the reasonably foreseeable risks, including risks to participant privacy, discomforts, or 
inconveniences associated with participants participating in the research. Note: All studies have the 
potential for risk, if not physical, there may be psychological, reputational, or financial risks or risks to 
breach of confidentiality.
Potential risks to confidentiality: There is a risk of breach of confidentiality, however we will 
implement safe guards to prevent this as outlined above in sections related to confidentiality.   
Potential risks of Behavioral therapies: Although Fathers for Change is a newer approach, 
other programs and agencies have worked with maltreating parents and their children and used 
play observations.(72) Additionally, we had no adverse events related to the intervention in our pilot 
studies of Fathers for Change. Psychological risks are minimal and not different from those of 
equivalent non-study psychotherapeutic interventions.
Potential risks of Rating scales and questionnaires: To participate in this study, subjects are 
asked to complete various forms and questionnaires during their initial enrollment, during 
treatment and post-treatment. All of the questionnaires are standardized and should add no risk to 
the subjects. Some of the questions are personal in nature and may be upsetting
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2.
Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
Potential risks to confidentiality: 
Potential risks to confidentiality: As detailed above, every effort will be made to maintain 
participant confidentiality. Confidentiality with regards to completed research forms will be 
maintained via numbered reference system maintained by the PI and Project Director. 
Participants names will appear only on the consent form, HIPPA authorization form and “key” form 
in a password protected file only accessible by the PI and project director. Subjects who decline 
participation in the study or those who wish to withdraw from the study can continue in their 
treatment at the outpatient facilities as they would if they were not approached to participate in a 
study. As stated above to further protect against potential risks to confidentiality for this 
population, a Certificate of Confidentiality will be obtained. Participants will clearly be informed of 
the limits of this confidentiality, which are in cases of suspected child abuse or neglect, and 
imminent risk for harm to self or others (particularly intimate partner or child).
Potential risks of Behavioral therapies: For the treatment conditions, frequent monitoring 
(at least weekly) of the participants’ clinical status by therapists and research staff will ensure 
identification and withdrawal from the study of participants who show significant psychological or 
symptomatic deterioration. If a participant shows significant symptomatic deterioration such that 
they are a danger to themselves or others or are in need of crisis intervention, the clinician, RA or 
project manager working with the participant will contact Drs. Stover or Sullivan immediately. Both 
are licensed clinical psychologists with extensive clinical experience with IPV offenders, victims 
and children who have witnessed violence or experienced maltreatment.  Drs. Stover,  and 
Sullivan  have over 15 years experience working with men with histories of IPV, victims and 
children who have experienced violence and maltreatment.  Dr. Silverman is also clinical 
psychologists with decades of experience with clinical populations.  Senior clinical supervision will 
be available at any time a client is being seen. Drs. Stover,  Sullivan, or  will assess the situation 
and assist with crisis stabilization, treatment planning, or facilitate inpatient psychiatric 
hospitalization if indicated. Participants who chose to withdraw or not participate in the study will 
have access to usual care at the facilities where the study is offered. 
Rating Scale and Questionnaires. Participants will be instructed that they can choose to skip 
any question or item if they do not want to answer. All the measures have been used in previous 
research with this population and in the pilot studies conducted by the PI or her co-investigators. 
The major disadvantage is the time taken to complete them. Our previous experience indicates that 
the baseline assessment will take 2 hours. A research assistant will meet with the participant online 
via zoom independent of their clinician and conduct all assessments. Only participants’ code 
numbers will be recorded on the forms themselves to protect confidentiality. Also, careful efforts 
aimed at maintaining confidentiality have been effective in previous research, and only participants’ 
code numbers will be recorded on the forms themselves to protect confidentiality. The study team 
(Drs. Stover and Sullivan) have extensive experience collecting IPV related data longitudinally from 
victims of IPV and have safely done so in previous studies.(88-90)  Procedures recommended in the 
literature and used in our prior studies of phone/text/email follow-up will be carefully adhered.
Additional Safety and Comfort: All research staff will receive substantial training and 
supervision to ensure that their interactions with all participants are not only professional, but also 
warm, friendly, non-confrontational, and respectful to all participants. We will take all precautions to 
ensure the safety of female co-parents of our male participants including: a) ensuring that partners' 
responses to all screening items are confidential from one another; b) allowing a male participant to 
remain in the study even if his female partner declines participation for herself or the child (he will 
not be informed of her decision instead he will be told the research team has decided to continue 
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with him individually); c) as outlined in the limits to confidentiality section of the study consent form 
(see above), in the event of any credible threat (harm towards life) made against a female partner, 
confidentiality will be breached per legal requirements and she and the police will be notified and 
informed of the potential danger to her; d) providing all female partners referral numbers to the CT 
Domestic Violence Services a 24 hour crisis support line and other treatment and community 
resources as needed if she contacts project staff with concerns.  Drs. Stover and Sullivan all have 
strong working relationships with the Connecticut Coalition Against Domestic Violence (CCADV) 
and the services provided by the statewide system of supports for victims of IPV.
Protection of Child Participants:  Children will be recruited into this study to participate in 
father-child observational assessments and for those over 7 answer self-report questions about 
their mental health symptoms.  These will provide an observational measure of father-child 
interactions providing an additional measure of change related to parenting and child maltreatment 
risk and child self-report of symptoms to corroborate the parent report data we will collect.  Fathers 
will be able to participate without their children to reduce any risks to the children for retaliation for 
their lack of participation.  Study research assistants will describe the study procedures to the child 
and ask if they would like to participate. Verbal agreement to participate and behavioral compliance 
without undue pressure from the father will be taken as assent from children given their young age.  
If a play session cannot begin once a father and child are at the research center or must be ended, 
father and child will be compensated for the attempt to provide data to minimize risk to the child for 
being uncooperative.  If a play session does not proceed, the father will continue in the study to 
randomization and treatment assignment.  Children will participate in free-play using age 
appropriate toys with their fathers for 15 minutes and then complete clean-up of used toys.  
Research assistants will be observing the session through a one way mirror or video in another 
room and will be trained to assess children’s distress level.  If at any time, the child becomes overly 
distressed from being in the room with their father or wishes to end the session, the session will be 
stopped and they will be offered their small toy to take home.  If ending the session and choosing 
their toy does not help them calm, Ras will call Dr. Stover,  Sullivan or . A senior member of the 
research team will always be available at the time of a father-child assessment in the event of 
distress of the child.  All  are licensed clinical psychologists with expertise in child development and 
child mental health treatment. They will be available to assess any child and provide crisis 
intervention, make referrals for needed services or treatment and provide support.  Given the play 
focus and limited demands of the assessment, there is limited risk for distress of the child 
participants.  
3.
Data and Safety Monitoring Plan:  Include an appropriate Data and Safety Monitoring Plan (DSMP) 
based on the investigator’s risk assessment stated below. (Note: the HSC will make the final 
determination of the risk to subjects.).
a.
What is your assessment of the overall risk level for subjects participating in this study?
Greater than minimal risk.
b.
If children are involved, what is your assessment of the overall risk level for the children 
participating in this study? 
Risk to children is minimal as their only participation is in play assessment with their fathers.  
These assessments will be observed through a one-way mirror.  
c.
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are  
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 available here http://your.yale.edu/policies-procedures/other/data-and-safety-monitoring-plan-
template  for
i.
Minimal risk
ii.
Greater than minimal/moderate risk
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i.
How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? Click or tap here to enter text.
ii.
What provisions are in place for management of interim results? Click or tap here to enter 
text.
iii.
What will the multi-site process be for protocol modifications? Click or tap here to enter 
text.
Summary of the Protocol
As detailed in the research plan and the protection of human subjects sections this study involves 
a randomized controlled trial of Fathers for Change compared to Batterer Intervention Program.  
For further details on the sample and inclusion/exclusion criteria, see the Human Subjects section.  
The Yale School of Medicine Child Study Center Parent and Family Development Program clinic 
will serve as the participating site.  The clinics will recruit participants, allow for data 
collection/assessments by study staff and offer space for provision of the study treatments.  
Roles and Responsibilities
Dr. Stover and the study team will review data integrity and safety during weekly team meetings. 
The post graduate associate and research interns will review assessment data and bring any 
concerns to Dr. Stover immediately if needed or in the context of weekly study review. Drs. Stover 
(Fathers for change) and Sullivan (Batterer Intervention) will also provide weekly supervision to 
study therapists, where they can report any concerns or safety considerations related to study 
interventions. Any significant study safety concerns related to participants will result in an immediate 
phone call to Dr. Stover and if needed Drs. Sullivan and Silverman.  Dr. Stover will not participate 
in data analysis.  Dr. Silverman or another team member masked to participant treatment group will 
carry out all statistical analyses related to study intervention comparisons.  
In accordance with Federal and Institutional regulations, a Data Safety and Monitoring Board 
(DSMB) for this study will meet quarterly to review aggregated study outcomes data and adverse 
events. The DSMB will be composed of three clinical investigators with expertise in working with 
men/fathers, forensic populations, and IPV victims/child witnesses who are not affiliated with this 
study. Dr. Stover will present these aggregated data on study outcomes and adverse events 
quarterly in a blinded fashion. 
Trial Safety
Participants would be excluded from further participation in the intervention if any of the following 
occur:
1) psychosis, 2) a domestic dispute or incident of child maltreatment that results in a full no contact 
order pertaining to the child, 3) suicidal ideation requiring hospitalization.  Overall, subjects will be 
dropped from the study if they show severe symptom deterioration, which would warrant transfer to 
another level of intervention.  
Mechanisms for trial safety and security have been detailed in the Human Subjects Section of this 
proposal.  
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The trial would be stopped if study interventions resulted in increased violence toward co-parents 
or children.  
Yale requires disclosure of any conflict of interest for study personnel.  Prior to beginning work on 
the study, all staff will complete a conflict of interest survey.  If a conflict is identified, prior to 
commencing work on the study a conflict of interest plan will be developed by the Yale Research 
Compliance Administrator, Conflict of Interest Program to ensure faculty or staff are in no way 
influencing the findings of the research.  
Reportable Events
The data with respect to adverse event (AE) severity and attribution of any adverse outcomes to 
study interventions or procedures will be based on coding procedures endorsed by the YALE IRB, 
as follows:
Coding of Severity:
0 = No adverse event or within normal limits
1 = Mild adverse event
2 = Moderate adverse event
3 = Severe, resulting in psychiatric or medical hospitalization
4 = Life-threatening adverse event
5 = Fatal adverse event
Coding of Attribution:
1 = Unrelated to study interventions
2 = Unlikely relationship to study interventions
3 = Possible relationship to study interventions
4 = Probable relationship to study interventions
5 = Definite relationship to study interventions
Event attribution may include the following study components: 1) Interventions; 2) Research 
Assessments; or 3) Study Procedures. On the basis of this review, after Dr. Stover excuses herself, 
the DSMB’s outside reviewers will deliberate, and submit a written report to the P.I., the Yale IRB 
and the Program Officer within 48 hours of these meetings, suggesting any recommendations for 
protocol modifications, or a recommendation to terminate the trial. While no unblinded interim data 
analysis is planned, if the DSMB independent reviewers suggest that an unblinded interim analysis 
is required, we will consult with the program official and the IRB, and a statistical penalty for this 
interim analysis may be taken if it is decided that the trial can continue. All adverse events graded 
3 or higher in severity and attribution will be considered as serious adverse events (SAEs), and will 
be reported within 48 hours to the Yale IRB HIC, and NIH. Reasons for terminating a subject’s 
participation (e.g. “stopping rules”) will include: 1) serious adverse reaction to study intervention 
Fathers for Change or BIP. Anticipated adverse events include increased negative mood, increased 
danger to female partner or child, and/or rearrests related to IPV or CM offenses or other non-family 
violence criminal charges. These will be assessed with rating scales. As these scales are assessed 
at baseline and during the experimental procedure, we will be able to determine if the event is 
attributable to the research. Otherwise, routine reporting of adverse events data will be done on a 
quarterly basis corresponding to the quarterly meetings of this study’s DSMB, using the following 
summary table which includes AE severity and attribution, as well as whether or not such AEs were 
anticipated (ATP) or unanticipated (UNATP).
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4.
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the participant(s) or to society at large. (Payment of participants is not considered a 
benefit in this context of the risk benefit assessment.) 
The major potential benefit of this study is the development of a feasible, evidence-based 
intervention that may be integrated into treatment clinics that addresses the intersecting issue of 
IPV and CM especially for those that have already failed the standard treatment as usual group 
Batterer Intervention program. The proposed intervention may decrease IPV and CM, which will 
benefit the men their co-parents and children. Additionally, male participants will be offered free 
treatment.
         SECTION VIII: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.
Alternatives: What other alternatives, if any, are available to the study participants outside of the 
research?
Participants will be able to receive intervention as usual offered at the Parent and Family 
Development Program if they do not want to participate in research.  
2.
Payments for Participation (Economic Considerations): Describe payments that will be made to 
participants, if any, the amount and timing of payments, and the conditions for receiving this compensation 
(if applicable). If you plan to hold a drawing, be sure to include the following on any consent or recruitment 
materials mentioning the lottery: 1) the value of the prize; 2) the sponsor of the prize (this cannot be a 
federal funding source); 3) the odds of winning; and 4) that there are no restrictions to winning.
Fathers and coparents will be paid $50 for their completion of baseline assessments.  Children 
younger than 7  will receive a small toy (worth $5-10) for completing play assessments.  All 
children in a family within the age range will be offered the toy to prevent any conflict within the 
family. Children over 7 will receive $20 for completing play assessments and symptom 
questionnaires.  
During Treatment: Fathers and coparentswill receive $5 for each completed weekly log over the 
18 weeks of treatment.  
Follow up interviews:
 Fathers and coparents will be offered $600 for post-treatment assessments, $60 for 6 month and $60 for 12-
month follow-ups. Payments for pre-post assessments and assessments during treatment will be 
paid in cash to participants when they attend in person treatment sessions. Alternatively, the 
participant will also be offered the option of receiving a reloadable Bank of America debit card 
which will be topped up by research assistants. For the mothers who will only have remote 
contact with RAs and clinicians in order to reduce contact and risk associated with COVID-19, 
they will be offered a reloadable debit card sent via post. 
3.
Costs for Participation (Economic Considerations): Clearly describe the participant’s costs 
associated with participation in the research, if any, and the interventions or procedures of the study that 
will be provided at no cost to participants.    
There will be no costs to participate in this study. Male participants will be offered free treatment. 
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31
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