Computerized Intervention for Reducing Intimate Partner Violence for Perinatal Women Seeking Mental Health Treatment
Phase: NA
Conditions: IPV, Perinatal, Mental Health
Sponsor: Women and Infants Hospital of Rhode Island

 
 
 
 
Strength for U in Relationship Empowerment (SURE)  
Study Protocol and Statistical Analysis Plan   
NCT04218864 
Document date: 12/20/2020  
 

 
 
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STUDY TITLE:   Computerized Intervention for Reducing Intimate Partner Violence for Perinatal   
  
            Women seeking Mental Health Treatment   
 
PI NAME:  Caron Zlotnick, PhD 
 
1. OBJECTIVES, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE 
 
Background 
Intimate partner violence (IPV) is a major public health concern for perinatal women.  The 
American College of Obstetricians and Gynecologists (ACOG) has defined IPV as violence by an intimate 
partner that may involve physical altercation (e.g., such as hitting, slapping or kicking), emotional or 
physical threats, and/or forced sexual relations.[1]  Prevalence rates of IPV prior to pregnancy (within the 
past year) range from 3% to 9%[2] and for the postpartum period rates of physical IPV ranging from 3.2% 
to 7.4%;[3,4] a rate that is in sharp contrast to the U.S. national average of 1.5% past-year prevalence for 
IPV among women.[5] When emotional abuse is included, studies have found from 21% to 33% of 
perinatal women report IPV.[6,7]  Furthermore, perinatal women report commission as well as receipt of 
IPV,[8] consistent with the larger literature that finds that the majority of IPV victims have comparable 
rates of perpetration behaviors. [9,10]  Bidirectional IPV can place women at high-risk for injury and 
revictimization.[11-13]  
Negative effects of IPV during the perinatal period:  Although IPV at any time during a woman's 
life is devastating, a woman who experiences IPV during the perinatal period is at risk not only for her 
own health (e.g., anemia, maternal death, and poor mental health,[14-16]) but also for the health of her 
developing fetus (e.g., preterm delivery, low birthweight[17] (see reviews,[18-20]) and the health of her 
infant (e.g., poor infant general health, difficult temperament,[21] deficits in emotional regulation,[22] 
eating and sleep disturbances[23], disturbed attachment relations).[24,25]  Based on this literature, 
researchers have suggested that exposure to IPV in infancy may be a key mechanism underlying the 
intergenerational transmission of IPV.[26] 
High mental illness burden among perinatal women with IPV:  There is mounting evidence from 
epidemiological studies that IPV markedly increases the risk of several psychiatric disorders.[27,28] In 
general, IPV is associated with mental health burdens among women, that includes depression, 
posttraumatic stress disorder (PTSD), low-self-esteem, suicidal thinking, and suicide attempts.[27,29-36] 
Specific to postpartum women, research has found a strong association between IPV and postpartum 
depression.[37-39]  Although no studies, to date, have focused exclusively on rates of psychiatric disorders 
found among pregnant women with IPV, research on perinatal women has found IPV-positive women to 
have a significantly higher rate of a current mood or anxiety diagnosis.[6]  In general, research has found 
prevalence rates of lifetime physical IPV among women with mental health disorders that range from 
50% and above[35,40-42] up to an astounding 75%.[42]  Furthermore, women who report bidirectional IPV 
report more mental health problems than IPV victims alone.[11,12] 
Screening and intervention of perinatal women at mental health clinics is important because: 1)  
A robust relationship exists between IPV and psychiatric disorders;[35,40-42] 2) The presence of IPV reduces 
the utilization of mental health care;[43,44] 3) In our study in which we conducted a retrospective chart 
review of 299 perinatal women attending mental health treatment, perinatal women with current 
victimization were more than twice as likely to leave treatment than those without current violence in 
their lives;[45] 4) IPV and untreated mental illness pose a dual threat of adverse health outcomes to a 
perinatal woman and her developing fetus/infant; 5) Untreated psychiatric disorders are associated with 
partner revictimization[46-49] and can interfere with IPV victims’ ability to effectively use important shelter 
and community resources necessary for establishing safety for themselves and their children;[6,50] 6) At 
least 20% of perinatal women seeking mental health treatment report ongoing interpersonal violence at 

 
 
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intake[45]; 7) Given the high rates of IPV among women who seek mental health treatment,[31,38-40] 
mental health treatment settings compared to other medical settings (e.g. primary care) are more 
effective sites for focused case finding and interventions.[51,52] 
Despite the need, recent research suggests that there are low screening and intervention rates 
of female mental health patients with IPV by mental health providers[35] psychiatrists hold less 
supportive attitudes towards IPV victims than other physicians,[53] IPV training and knowledge of 
resources is limited among psychiatric residents,[54] and mental health professionals find enquiry about 
domestic violence difficult because of their lack of knowledge and expertise in this area and/or because 
they do not think it is part of their role.[55]  As researchers have noted, there are much needed but 
inadequate systems in place for mental health clinics or providers to respond to women with IPV.[51,52]  
Virtually no empirically-based interventions exist that address IPV among mental health treatment-
seeking perinatal women.  Women in the perinatal period were selected for two primary reasons: (a) 
interventions at this juncture may take advantage of a particularly salient point in a woman’s life, in 
which she may be more open to considering behavior change; and (b) any positive change made has the 
possibility of a dual impact, on the woman’s life as well as that of her infant.  The proposed project will 
test an innovative, high-reach, easily implementable, low-cost computer-delivered intervention, Reach 
Out for a Safe Environment (ROSE), which is theoretically driven and addresses known barriers in early 
intervention with at-risk women throughout the perinatal period.  Preliminary data from our pilot study 
provide reassurance that ROSE will successfully reduce IPV in our target population.  A fully powered 
RCT trial of ROSE is necessary to determine efficacy. A cost estimate in a real-life clinical setting will 
provide information to facilitate implementation and dissemination. 
The intervention (ROSE) will represent the first IPV risk reduction intervention for women, which 
is tailored to the specific needs of perinatal women with IPV within a mental health treatment setting.  If 
the proposed intervention is found to be efficacious in our vulnerable target population, we anticipate 
that it could have significant implications for IPV prevention efforts for other childbearing victimized 
women seeking mental health treatment and victimized women, in general.   
 
Objectives 
In our R21 preliminary work, we demonstrated the feasibility and acceptability of ROSE, a 
computerized intervention for perinatal women with recent IPV who seek mental health treatment.  In 
our pilot work, there were high ratings of satisfaction for ROSE. 100% completed the computerized 
intervention; 93% participated in the booster and 92% in the 4-month follow up assessment.  Further, 
participants in the ROSE condition demonstrated a significantly larger change in frequency of IPV from 
baseline to follow-up (4 months after intake) than participants in the control condition (p < 0.007).       
The goal of this proposed study is to build upon these promising preliminary findings by testing 
whether ROSE reduces the frequency of IPV in a larger sample of perinatal women seeking mental 
health treatment, compare the effects of ROSE to an attention, time, and information matched control 
condition in two real-life clinical settings, examine the effects of the intervention for a more extended 
period of time, and include a cost estimate of ROSE.  To achieve this, we propose a two-group, 
randomized controlled trial in which 186 perinatal women seeking mental health treatment are assigned 
to either (a) a computer-delivered, single-session brief intervention plus one interventionist-led phone 
booster; (ROSE); or (b) a computer-delivered control + one interventionist-led phone booster condition.  
Computer-delivered follow-up assessments will occur at 6-weeks, 3 months, 6 months, and 12 months 
after the baseline assessment. More specifically, we propose the following Specific Aims: 
 
Aim 1 (Primary Outcome) 
To test the hypothesis that ROSE, compared to an attention, time and information matched control 
condition, will be associated with a lower frequency of IPV among perinatal women seeking mental 
health treatment at 6-weeks, 3 months, 6 months, and 12 months follow up.  
 
 
Aim 2 (Secondary Outcomes) 

 
 
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(a) ROSE, as compared to control, will result in greater positive affect and well-being at 6-
weeks, 3, 6- and 12-months follow up; 
(b) ROSE, as compared to control, will result in greater perceived emotional support at 6-weeks, 
3, 6- and 12-months follow up; 
(c) For future implementation and dissemination, we will estimate the resources needed and 
costs to deliver ROSE.  Additionally, we will estimate the incremental cost effectiveness of 
ROSE compared with treatment as usual. 
 
Aim 3 (Mediation)   
To examine the role of theorized mediators of empowerment and self-efficacy on the effect of SURE.   
 
2. STUDY DESIGN, METHODS, AND PROCEDURES 
 
Study Design  
Women (18 to 45 years old) presenting for an intake appointment at The Center for Women’s 
Behavioral Health (WBH) at Women and Infants Hospital (WIH) and at The Perinatal Psychiatry Clinic 
(PPC) at the University of Michigan Health System (UMHS) will be screened for IPV victimization. 
Women who are pregnant or within 12 months postpartum – and report past 12-month history of 
IPV will be invited to participate in the study. At each site, those providing informed consent will be 
randomized either to an attention, time and information matched control condition or ROSE arm.  
Participants in both conditions will receive a phone booster within 4-weeks of their baseline 
assessment. Follow up assessments consisting of validated questionnaires will occur at 6-weeks 
after baseline assessment, and 3-, 6-, and 12 months, which will capture both immediate and 
sustained change and allow us to capture trajectories of IPV change. The booster session will be 
audio recorded so that adherence and competence ratings of the booster sessions can be 
conducted. These digital recordings which will be labeled with the study identification number and 
the booster session date and will be transferred to Women and Infants Hospital secure computer 
server via a secure server access. Access to the audio recordings will be limited to research staff. See 
“Sources of Materials” section for the assessments to be collected at each time point. If participants 
do not want to be audio recorded, they can still participate in the study. 
 
Intervention Conditions 
1. Reach Out for a Safe Environment (ROSE)   
ROSE participants will receive a 40-minute online/computer-based intervention immediately 
after their baseline assessment and an in-person 30-minute booster session conducted by 
interventionists within a month after the intervention. The online intervention will be sent by 
email as a link (URL) to the intervention. The link will not contain any wording that could reveal 
the nature of the intervention/study.  The link will become inactive once the intervention is 
completed. If online, research staff will call ROSE participants after the intervention in case they 
have questions after the completion of the online session.  If on site, research staff will be 
available after the intervention in case ROSE participants have questions after the completion of 
the session. The ROSE Program is specifically tailored, innovative and relevant to diverse, racial 
and ethnic perinatal women in a number of ways including the images and content used in the 
intervention. It will also be tailored on the current IPV risk assessment, pregnancy or 
postpartum status of each participant, will be designed to reach participants across levels of 
motivation for change, and will follow guidelines for brief interventions as recommended by the 
ACOG.  The content of ROSE is theory-driven, consistent with the MI model of behavior, and 
consistent with the literature on effective interventions that address IPV.   
 

 
 
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Possible distress due to sensitive items will be noted clearly in the informed consent information 
sheet (for screening) and in the written informed consent form (for participants). All participants 
will be told that they can skip any question or quit at any time if they become uncomfortable. To 
further address possible distress due to sensitive items, participants will be asked by the 
research assistant if anything during the assessment or intervention has made them feel upset. 
At a minimum, all participants indicating some distress will be given a list of referral options. If in 
treatment women will be encouraged to contact their mental health provider. Suicidality will 
not be assessed during the course of this research study.  
 
2. Control Condition 
The control condition will be the same, well-validated, attention, time and information-matched 
online/computerized control intervention condition used successfully in our previous studies 
with perinatal women, in which ratings of acceptability were equally high among intervention 
and control group participants. The online intervention will be sent by email as a link (URL) to 
the intervention.  The link will not contain any wording that could reveal the nature of the 
intervention/study.  The link will become inactive once the intervention is completed. This 
condition consists of a series of questions regarding television show preferences and viewing a 
brief series of videos of popular entertainers/shows, with subsequent requests for ratings of 
subjective preference. This content will serve to control time and help to limit inadvertent 
therapeutic effects that plague control groups in brief intervention research.  The telephone 
booster session will be comparable in time to ROSE’s telephone booster session (10-15 
minutes).  The booster session will consist of an interventionist reviewing with the participant 
her ratings of the various of popular entertainers/shows that she watched in the intervention, 
discussing with the participant more in-depth her preferences, and discussing any other forms 
of entertainment/shows that participant has watched, heard of, or would like to see. 
 
Interventionists 
 
Interventionists for the ROSE and control booster sessions will be trained for both conditions.  
Dr. Zlotnick has previously successfully trained interventionists with Bachelor of Arts Degree to 
administer the highly scripted MI-based intervention booster session.  In our pilot study, 
interventionists with only a bachelor’s degree were successfully trained for the MI-based 
booster (independent ratings for adherence and competence were very high).  There will be a 2-
hour training that consists of a review of MI and empowerment principles, how to conduct the 
booster session, and role-plays of standard, challenging, and emergency situations.  Training for 
the booster control condition will be 45-minutes and involve instruction on how to conduct the 
booster session and role-plays of challenging and emergency situations.  
  
Economic Considerations 
Participants will receive check or gift cards (total equivalent up to $215) for their participation. 
Participants will receive a $5 gift card for completing screening, $30 for completing the baseline 
session, $20 for the booster session, $30 for 6-weeks, and for 3 month follow-up assessment, 
$40 for the 6-month follow-up, and $60 for the 12-month follow-up.  For women who choose to 
do follow up assessments over the phone we would ask them for their Social Security Number if 
they preferred a check for their monetary compensation to be mailed to them  or an gift card.  
Cab transportation through a voucher system arranged with a local cab company will be 
provided for participants who may not own or have access to a car and need to have 
transportation in order to attend study procedures. Child-care expenses or data usage expenses 
will be reimbursed to the study participants at a rate of $10 per hour for up to a 2 hour time 

 
 
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period when applicable.  Women who do not live alone and do not have headphones will be 
sent a set of headphones to view the online intervention.  
Overview of study phases  
 
 
 
 
 
 
 
 
 
 
 
Inclusion and Exclusion Criteria/ Study Population 
The inclusion criteria of this study are being a woman 18 to 45 years old who presents for an intake 
appointment at The Center for Women’s Behavioral Health (WBH) at Women and Infants Hospital 
(WIH). Women who are pregnant or within 12 months postpartum – and report past 12-month 
history of IPV will be invited to participate in the study. Other inclusion criteria are the ability to 
understand study procedures in English, and willingness to complete follow-up session. 
 Exclusion criteria include: 1) No access to a computer (PC, tablet, iPad, Mac) or Smartphone (a 
device with internet) and unwilling to come to the hospital to be consented and to view the 
intervention; 2) Reports discomfort with using the internet and unwilling to come to the hospital to 
be consented and to view the intervention;   3) Living with an abusive partner,at risk for severe 
injury or homicide as determined by the 5-item Danger Assessment, unwilling to create a private 
email and unwilling to come to the hospital, 4) Has a past or current abuser who is making the 
woman feel unsafe or she has no private email and unwilling to set up a temporary email or come to 
the hospital to be consented and to view the intervention, 5) Reports no privacy to view the consent 
form online and  view a 40-minute online  intervention on domestic violence and unwilling to come 
to the hospital to be consented and view the intervention. 6) Responds yes to any of the questions 
to determine if Spyware or Stalkerware is likely operating on her device and is unwilling to come to 
the hospital to be consented and view the intervention.  Others include inability to provide informed 
consent (e.g., due to psychosis, intoxication, or other clear cognitive impairment) or  inability to 
understand English (understand the consent form when read aloud and assessments that are 
narrated by computer). Perinatal transgender men will be excluded because transgender persons 
confront many IPV issues that are unique to them as a group.  
 
Screening 
Information Sheet 
Informed Consent 
Randomization
Baseline 
ROSE 
Intervention 
1-month  
ROSE Booster  
Session
Control 
Baseline 
6-weeks, 3-, 6, 
12-month 
follow-up 
assessment 
1-month  
Control 
Booster

 
 
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Plan to Include a Diverse Population 
We will be including pregnant women in our study. Intimate partner violence (IPV) is common 
among perinatal women, especially those with mental health issues. IPV is associated with negative 
consequences for the mother, fetus, and infant. The presence of mental health difficulties in 
addition to IPV compounds adverse health risks. Very few IPV-focused interventions have reduced 
IPV among perinatal women, and there are currently no brief IPV interventions and none for 
perinatal women seeking mental health treatment. This study will test an innovative, high-reach, 
easily implementable, low-cost, theoretically driven online/computer-delivered intervention. This 
study holds out the prospect of a direct benefit both to the pregnant woman and the fetus and is no  
greater than minimal risk. Furthermore, the knowledge we hope to gain from this study that will  
also help future pregnant women cannot be gained without including the patients we enroll into the  
study. The risk is the least possible for achieving the objectives of this research, and we will be  
minimizing anticipated risk in various ways. 
Perinatal transgender men will be excluded because transgender persons confront many IPV issues 
that are unique to them as a group.  
 
Number of Subjects 
93 subjects will be recruited at the Center for Women’s Behavioral Health (WBH) at Women and 
Infants Hospital (WIH). Another 93 subjects will be recruited at the Perinatal Psychiatry Clinic (PPC) 
within the University of Michigan Health System (UMHS). 
 
Setting 
The research study sites will be patients from the Center for Women’s Behavioral Health (WBH) at 
Women and Infants Hospital (WIH), and patients at the Perinatal Psychiatry Clinic (PPC) within the 
University of Michigan Health System (UMHS). Collaborators at the University of Akron will help with 
analysis of de-identified data. 
 
Recruitment Methods and Informed Consent Process 
The clinical trial will be conducted at two sites. We will recruit perinatal women from The Center for 
Women’s Behavioral Health (WBH) at Women and Infants Hospital (WIH) and from The Perinatal 
Psychiatry Clinic (PPC) within the University of Michigan Health System (UMHS).  Participants will be 
186 pregnant or postpartum women (up to 12 months after delivery), 18 to 45 years of age, who 
have received clinical services at WBH (i.e., initial assessment or treatment) within the last twelve 
months. We have included women who are up to 12 months postpartum, because there is general 
consensus in the literature that postpartum refers to 12 months after delivery [56].   In addition, the 
perinatal women will have endorsed any IPV during the past 12 months as measured by the Woman 
Abuse Screening Tool (WAST[57]).  The WAST is an 8-item instrument that measures physical, 
sexual, and emotional abuse and is consistent with the definition of IPV as defined by The American 
College of Obstetricians and Gynecologists[1,57]. It has correctly classified 100% of nonabused 
women and 92% of abused women in a known-group analysis[57], has good internal reliability[58], 
and has adequate concurrent validity, even with ethnic minorities[58].  Consistent with similar 
studies, IPV status will be positive if a woman obtains a score of 4 or more on the WAST.  Other 
inclusion criteria will be ability to understand study procedures in English, and willingness to 
complete follow-up session.  
 

 
 
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Participants will be recruited from The Center for Women’s Behavioral Health (WBH) at Women and 
Infants Hospital (WIH) who are attending either the Postpartum Day Hospital or Behavioral Health 
for an intake assessment or for treatment. Contact information for potential participants who have 
received services at WBH in the last twelve months and are pregnant or postpartum will be 
extracted from the Women and Infants Hospital’s electronic medical system, EPIC.  The research 
assistant will contact these pregnant and postpartum women and asked if they are interested in 
participating in a brief health survey. Research Assistants (RA) will also use WhatsApp to contact 
women, only if already have the app. Otherwise, RAs will call regularly, not through the app. Women 
recruited from The Perinatal Psychiatry Clinic (PPC) within the University of Michigan Health System 
(UMHS) will follow a similar recruitment procedure.  (The PCC study site will be overseen by 
University of Michigan’s IRB.  Dr. Tzilos (Co-I) will be responsible for all regulatory documents for 
and communications with University of Michigan’s IRB). 
 
This information sheet will be anonymous and will not collect any identifying information. This 
approach is being used as the research presents no more than minimal risk of harm to participants 
and involves no procedures for which written consent is normally required outside the research 
context. Those participants who qualify at screening and wish to continue with the study will give 
phone consent to use their information from the screener as part of the phone consent process. 
The information form will explain in detail the kinds of questions that will be asked, the rights of the 
woman to not participate or to quit at any time, and the potential risk of distress.  In the current 
study, the anonymous survey will not include information that will identify who does and does not 
choose to participate.  
 
Women who indicate orally their interest in continuing with the survey will then be introduced to 
the survey by the RA, which will be described as a survey to help moms have healthier pregnancies 
and be healthy during the postpartum period. The RA will then over the phone conduct a short (5-10 
minutes) health survey including questions to determine eligibility.  Research staff would document 
that it was an oral consent without signature, and include the date and time the oral consent was 
obtained. Women who refuse to complete screening, or if after completing screening refuse to 
participate in the study, will be asked by the research assistant about possible reasons why she 
refused.   The screening will not include any identifying information and will include a brief series of 
questions about general health, exercise, diet, smoking, access to and comfort with the internet, 
and a question regarding when the participant learned of her pregnancy or delivered her baby. 
 
Those meeting study criteria will be given the opportunity to provide informed consent for the study 
or provide phone consent to be contacted to set up a future appointment with the research staff.  
RAs will ask those eligible if their contact information obtained from EPIC can be used in the future, 
to ensure safety and privacy. This will also include permission to text, email, and which times are 
best for RA to call.    
 
Research staff will carefully explain all aspects of the study to a potential recruit, including the risks 
and benefits and that their participation is voluntary. Recruits will be informed of the study 
commitment. Prior to phone consent, recruits with a past or current abuser who is making her feel 
unsafe, recruits living with an abuser, or recruits who have no private email will be asked if they are 
willing to set up a temporary email.  If no or unwilling to come to the hospital to view the 
intervention, these participants will be excluded.  Likewise those who report no privacy to view a 40-
minute online intervention on domestic violence and unwilling to come to the hospital to view the 
intervention will be excluded (See exclusion criteria). Questions to determine if Spyware or 

 
 
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Stalkerware is operating on the recruit’s  devices will be asked. To establish safety, women living with 
a current abusive partner will be asked about their risk for severe injury or homicide as determined 
by the 5-item Danger Assessment. If women meet criteria for severe injury or homicide risk or risk of 
spyware or Stalkerware, they will be given the option to come into the hospital to be consented and 
view the intervention, 
 
 As part of the phone or in-person consent those who qualify will be asked to share the information 
gained from the screener survey as part of the study data. Participants will be reminded that they are 
not required to participate in the study and that they will receive the standard care provided by WBH 
and Women and Infants Hospital regardless of whether or not they choose to participate.  
For those recruits who need to set up a temporary and secure email for safety reasons to view the 
online intervention, the research assistant (RA) will guide the recruit on how to set up a temporary 
and secure email that once deleted cannot be accessed/retrieved.  The RA will send the study 
consent in the body of the email (to prevent a download) to the temporary and secure email address 
or to a woman’s private email. The research assistant will orally describe the material written in the 
informed consent document and answer any questions the participant may have. Participants will be 
asked to complete a brief (five-question) true/false quiz after reviewing the consent form to ensure 
subject comprehension. If not in-person, women will not be asked to sign the consent for the online 
intervention.  Return of the consent would involve downloading the document, printing it, scanning 
or mailing it back; activities that could pose safety issues. Research staff will therefore obtain phone 
consent. Research staff will document that it was an oral consent without signature and include the 
date and time the oral consent was obtained in password-protected document on a secure server. 
For in-person , they All women who meet study criteria whether they choose to participate in the 
study or not will be provided information (online resources and relevant phone numbers) and 
community resources (online resources and relevant phone numbers) for IPV, if interested. These 
resources can be provided on the phone or emailed, if safe to do so. If the participant decides to view 
the intervention in-person, research staff will provide handouts on resources. Women who agree to 
participate in the study remotely will be asked what device they will use to view the intervention and 
if they say they will use their iPhone or iPad, the RA will proceed to provide the participant 
instructions on how to download the CIAS app. 
 
 
After consent has been obtained, the RA will complete a locator form for the participant (if over the 
phone) or the participant will complete the form in the office. The baseline assessment will then be 
conducted on the phone or in-person.  After the participant completes the screener assessment, is 
eligible for the RCT, has consented for the RCT, and has completed the baseline assessment, 
research staff will send a link to the intervention or will set up the intervention on the tablet at the 
hospital. The computer program will randomize participants into control vs. ROSE conditions. For 
participants coming to the hospital, optimal procedures to minimize risk of COVID-19 exposure will 
be used. At the time of screening, 3-month, 6-month, and 12-month assessments, we will as 
participants when their last appointment at WBH was.  
 
Participants will be able to change their contact preferences at any point. Participants will be told 
they are able to drop out of the study at any point and that dropping out will not have any impact 
on the care that they receive at Women and Infants Hospital. 
 
Recruitment procedure graphic 

 
 
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Data Collection Procedures 
Participants meeting inclusion criteria for the RCT will complete an approximately 15-20 minute 
 assessment session or a computer assessment on the Tablet PC if at research site.  All of the self-
report measures included in this study have good psychometric properties (see Table 1, below)  
 
 
All follow—up assessments will involve the research assistant administering follow up assessments 
via a phone session or at the hospital.  
 
Contact information from EPIC for women who have 
received clinical services at WBH  
Women will be contacted  if 
interested in study. If interested 
will be read information sheet on 
phone call.  
Women not interested. 
Excluded. 
 
Women who indicate orally 
interest in the information 
sheet will complete the 5 minute 
computer screener for eligibility. 
 
Women who do not indicate 
orally interest in the 
information sheet  
Excluded. 
 
Women who meet study 
criteria will be explained study 
and informed consent will be 
obtained by phone or in-person. 
 
Did not meet study criteria.  
Excluded. 
 
Women who give informed 
phone or in-person consent 
will receive information and 
community resources for IPV 
and be eligible to participate in 
RCT study. 
Women who do not give 
consent or are ineligible will 
receive information and 
community resources for IPV.   
Excluded.   

 
 
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The booster session will be audio recorded so that adherence and competence ratings of the 
booster sessions can be conducted. These digital recordings which will be labeled with the study 
identification number and the booster session date and will be transferred to Women and Infants 
Hospital secure computer server via a secure server access. Access to the audio recordings will be 
limited to research staff. Participants can still participate if they do not want to be audio recorded. 
The informed consent form asks the participant to select if they do or do not want to be audio 
recorded. 
 
In cases when research staff are working remotely from home or other locations, they will have 
remote and secure access to study documentation and will be able to conduct booster sessions, 
assessments, referral follow-ups, as well as set up and confirm appointment times using study 
phones.  If working remotely, research staff will conduct these calls in a private and confidential 
setting and will not carry or have in their possession any hard copy PHI (e.g., participant telephone 
numbers) at home or any other location outside of the hospital setting.  
 
The follow-up sessions will consist of administering the various scales, as seen below. 
 
Sources of Materials 
 
The following assessment measures will be administered at the baseline assessment: 
1. Demographic information, including age, race, ethnicity, marital/partner status, parity, employment, 
socioeconomic status. 
2. Relationship information, such as current relationship to abuser/s, length of relationship/s, etc. 
 
 
Primary Outcome Measure: 
At baseline frequency of IPV for the past 12 months will be measured using the Composite Abuse 
Scale (CAS[60]). The CAS assesses the frequency of psychological, physical, sexual, and combined 
severe violence for each intimate relationship over a specified period of time. The CAS has 
demonstrated face, content, criterion, and construct validity[61]. The scale as a whole and its 4 
subscales have all demonstrated good internal consistency and reliability[61]. The instrument will be 
administered at baseline and at each follow-up interval.   
   
Secondary Outcome Measures:  
1. Positive affect and well-being (i.e., aspects of a person’s life that relate to a sense of well-being, 
life satisfaction or an overall sense of purpose and meaning) will be measured by using the NIH 
Neuro-QoL scale for positive affect and well-being, a computerized adaptive test 9-item scale[62].  
This self-report measure for adults is intended for use in clinical trials and allows for cross-disease 
comparisons, which is well suited to our target population who present with an array of mental 
health difficulties.  The measure has demonstrated sufficient reliability, internal consistency, and 
concurrent validity[63,64].  
2. Perceived emotional support will be measured using a 4-item scale developed by the Patient-
Reported Outcomes Measurement Information System (PROMIS). PROMIS is a National Institutes 
of Health (NIH) Roadmap initiative that provides precise, reliable, valid, and standardized 
questionnaires measuring patient–reported outcomes across the domains of physical, mental, and 
social health[65]. The PROMIS emotional support item bank specifically aims to assess perceived 
feelings of being cared for and valued as a person[66,67]. 
3. COVID-19-related stress since the outbreak will be measured using a 7-item scale assessing 
different types of stressors.   
 
 

 
 
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Costs:   
A secondary aim of this study will be to measure the total costs of ROSE vs. usual care for those at 
risk of IPV at participating study sites.  Adhering to Second Panel on Cost-Effectiveness in Health and 
Medicine Guidelines[68], we will perform a cost-effectiveness analysis (CEA) to estimate the cost per 
IPV incident prevented by ROSE. Cost will be measured relative to usual care, with IPV reduction 
proxied by comparison to the research assistant blindable control condition that should be 
equivalent to usual care. We will collect data on three types of costs: 1) Implementation costs of 
establishing the ROSE program in a mental health clinic, including staff training time and resources, 
costs of hardware, software licensing, and adaptation of the program content to be relevant to the 
location; 2) Operational costs, including the human labor involved in identifying eligible patients, 
conducting screening, introducing patients to the program and demonstrating how to use it, 
obtaining follow-up information, and conducting the booster call, and 3) Participant costs in terms 
of time spent at the intervention and booster session, plus any travel costs related to intervention 
attendance, beyond the session where the person was screened. To record the first two sets of costs 
and distinguish them from research activities, the research assistants and the interventionist will 
track and log times for all study activities. The third set of costs will be captured by including 
questions about travel/waiting time, occupation, wage rate, and out-of-pocket expense in the 
survey at each added visit.  
 
Exploratory Potential Mediators: 
We hypothesize that self-efficacy and empowerment will mediate the relationship between the 
effects of ROSE and the presence of IPV (see Figure 2).  
1.  Empowerment will be measured using the Personal Progress Scale-Revised (PPS-R[69]) for 
accessing skills, social supports, and resources to cope more effectively with relationship stress and 
trauma.  PPS-R is often used to evaluate empowerment-based interventions.  The measure has 
shown good reliability and validity[69]. 
2. Self-efficacy will be assessed with the General Self-Efficacy Scale, a 10-item self-report 
measure[70]. It measures personal competence to deal effectively with a variety of stressful 
situations. The scale has been found to be reliable, homogeneous, and unidimensional across 25 
nations[71].  
 
Perinatal Depression:   
At all follow-up assessments, participants will be screened for perinatal depression because the 
majority of women seen at both sites report perinatal depression and perinatal depression is 
strongly associated with IPV [72,73].  Any participant who screens positive for postpartum 
depression (The Pregnancy Risk Assessment Monitoring System 6 (PRAMS-6) score of 17 or more) 
will be referred for appropriate local clinical care [74].  
 
Danger Assessment (DA)-5.  The DA-5 was developed for use in healthcare settings, including 
emergency and urgent care settings to evaluate the risk of an intimate partner violence victim being 
killed, nearly killed or severely injured by an intimate partner [59]. The DA-5 was found to have 
adequate validity and is recommended for a quick assessment of homicide or near homicide risk 
among IPV survivors [59] 
 
 
 (See Protection of Human Subjects).   
 
Data Collection at the University of Michigan Site 
The University of Michigan site is the other site in this study. This site will be conducting the same data 
collection procedures. This site will send de-identified data to the Women and Infants site to be 
analyzed. The Women and Infants site will not send any data to the University of Michigan site. 
Table 1:  Study Measures  

 
 
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Intake 
6-weeks  
3-months  
6 months and  
12 months 
Self-report Measure  
 
 
 
 
Demographics and IPV information 
X 
X 
X 
X 
Composite Abuse Scale 
X 
X 
X 
X 
Positive Affect and Well-being 
X 
X 
X 
X 
Perceived Emotional Support 
X 
X 
X 
X 
Personal Progress Scale-Revised 
X 
X 
X 
X 
General Self-efficacy Scale 
X 
X 
X 
X 
Edinburgh Postnatal Depression Scale 
 
X 
X 
X 
COVID-19 Family Stress Screener 
X 
X 
X 
X 
Economic Measure  
 
 
 
 
Cost Analysis 
X 
X 
X 
X 
 
3. RISKS AND BENEFITS 
 
Potential risks 
There are five potential low- to moderate-risks to subjects associated with this research project:  
Breach of confidentiality: Assessment procedures could reveal sensitive information about participants’ 
medical history and history of IPV. Risk of breach of confidentiality is possible, though highly unlikely. 
Specifically, if a participant tells research staff that she is planning to harm herself or her children, the 
research staff will report this information to the appropriate agency, as required by law. Other than the 
need to report those incidents that are regulated by mandatory reporting laws, we feel that there is 
minimal risk to participants with regard to other breaches in their confidentiality.  
Coercion: Coercion occurs when potential participants feel compelled to participate in research for 
reasons such as perceived demand or the availability of large sums of reimbursement. This can be 
particularly true when there is little benefit to the individual for their participant (not an issue in this 
study). In the present study, the inclusion of a protected population and protection from coercion is of 
the utmost importance.   
Discomfort: Participation in the study may lead to psychological distress due to the sensitive nature of 
questions regarding disclosure of IPV during the perinatal period and the related negative social and 
psychological consequences.     
Study-related partner violence: Participants who return to or continue to have contact with their abuser 
may be at increased risk for abuse if he or she were to find out about the woman’s participant in the 
research project.  
Social or legal consequences: Possible social or legal consequences due to revelations of IPV during the 
perinatal period.  
 
Adequacy of protection against risks 
At each point of contact in the studies, participants will be reminded of the alternative of not 
participating in the study (or once enrolled, to discontinue participation), and will be informed that their 
care at The Center for Women’s Behavioral Health at Women and Infants Hospital and in any other 
follow-up medical care will in no way be affected by their decision to participate or not to participate in 
the study. Moreover, we will provide referral information to all participants at each point of contact.  
We will also remind participants that they should only keep handouts related to the study if they feel it 
is safe to do so.  If they feel that it may be unsafe to keep any handouts, participants will be advised to 
discard these prior to leaving the assessment/intervention session. Further procedures to minimize each 
of these risks are described below.  

 
 
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Protection against risk 
We will take the following steps to protect against risks associated with this research project: 
 
We will minimize the risk of breach of confidentiality.  
Risk of social or legal consequences as a result of disclosure of IPV within the past year will be dealt with 
in several ways. We will minimize the potential risks due to loss of confidentiality by strictly adhering to 
the guidelines for research outlined by Women and Infants Hospital IRB, Rhode Island state law and the 
DHHS Federal Policy for the Protection of Human Subjects (45 CFR Part 46 Subpart D). As described in 
the previous section, there will be full informed phone or in-person consent prior to participation in the 
study (a two-part consent process). Participant data will be encrypted in transit between user and 
server. No identifying information will be entered into the ACASI. The use of a linking table will provide 
the participant with confidentiality as the link between the participant code number and name will be 
kept in a password protected file on password protected computer. Lastly, potential participants will be 
informed of the situations in which they may not be protected under the Certificate of Confidentiality. 
No information about participants will be released without their permission or where required by law.  
 
Possible distress due to sensitive items will be noted clearly in the informed consent information sheet 
(for screening) and in the written informed consent form (for participants). All participants will be told 
that they can skip any question or quit at any time if they become uncomfortable. To further address 
possible distress due to sensitive items, participants will be periodically asked by the research assistant 
(RA) if anything the RA has asked or done is making them feel upset right now.  For both the online 
intervention and in-person computer-delivered intervention, the research assistant will contact the 
participant after 40 minutes, the time it takes to watch the intervention and inquire if anything in the 
intervention distressed her. . At a minimum, all participants indicating some distress will be given a list 
of referral options. If in treatment women will be encouraged to contact their mental health provider.   
 
We will minimize the risk of study-related partner violence.  
Participants who return to or continue to have contact with their abuser may be at increased risk for 
abuse if he or she were to find out about the woman’s participation in the research project. The 
measures suggested by Sullivan and Cain (2004) will be taken to maximize participant safety throughout 
the research[75].  The office research line is a number that is blocked and the line will be answered, 
“Women and Infants Program,” and partner violence will never mentioned. Likewise, staff work cell will 
be answered with Women and Infants Program.  When potential participants are contacted through text 
or email using contact information obtained from EPIC, RAs will let potential participants know that they 
are from Women and Infants Hospital and that they will be calling them and provide their study cell 
number.  If reference to the screener is made in text or email, it will be referred to as a brief women’s 
health survey. Details of the research are not provided to anyone other than the actual participant. 
During each contact, participants will first be asked if it is a safe time to speak. Safe contact for follow-up 
assessments will be negotiated at each stage of the research. Both written and verbal contacts will be 
vague and never mention that the research involves partner violence.  Safety plans will be negotiated up 
front (e.g., code words, cover story for reason for interview) if ever the abuser were to interrupt a 
phone call or assessment or –if during a call to the participant there is noise and concern for the safety 
of the participant, research staff will ask the participant if she is safe and ask if the police needs to be 
contacted. If participant says yes to police being contacted, the research staff will call the police. Any 
handouts with important information (e.g., hotline numbers) will be available in wallet size copies 
without any reference to the study or name of organization.  Participants’ safety contact information, 
including the Locator Form, will be updated and confirmed at each assessment to determine if the 

 
 
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contact information they previously provided is still accurate and safe. Initial contact information 
collected prior to screening in the contact form will be placed in a secure, password protected excel 
sheet the same day. Contact forms will then be shredded by the RA. After one month the contact 
information will be deleted from the protected excel sheet. Participants will be given contact 
information for the research team and asked to let us know if the contact information they provided is 
no longer safe.  All research personnel (i.e., PI, research assistant, interventionists) will be able to call 
the PI for advice on cases where there is a concern for the safety of the respondent and the PI will be 
available at all times by pager.  Research staff will contact PI, if there are any safety concerns.  
 
The online intervention will be sent to a secure email as a link (i.e., URL) to the intervention.  The link 
will not contain any wording that could reveal the nature of the intervention/study.  The link will 
become inactive once the intervention is completed. Women can hit the stop button at any time during 
the intervention and it will stop immediately. Women can also click an escape button during the 
intervention that will redirect her to the Google search page. The link (URL) can then be sent again and 
the participant can continue with the intervention from the place where she stopped.  If the woman 
chooses to view the online intervention remotely through their iPhone or iPad, they will have to 
download the CIAS app from the app store to open the link for the intervention. The app itself has as its 
only description as "Medical" and "Wayne State University". The image of the app has a yellow heart 
with a stethoscope. When the participant uses the emailed link to view the intervention, the CIAS app 
will automatically open. This is the only time the CIAS app will show information about the study. If 
another person were to open the app at another time, they would be unable to see the completed 
intervention. Although the proposed intervention seeks to help a woman to develop strategies for 
keeping herself safe, it is possible that a woman who participates in the study might be at increased risk 
of partner violence because of increased assertiveness. At each follow-up assessment, our assessment 
of community resource use will ask about participants’ visits to emergency rooms, health professionals, 
etc. The Composite Abuse Scale (CAS) will be administered to monitor abusive experiences in the context 
of a woman’s relationship since the last assessment. Women will be asked at follow up sessions about 
any instances of hospitalizations, emergency room visits, life threatening threats of IPV, rape, or sexual 
assault to better gather information regarding any potential adverse events to report to the Data Safety 
Monitoring Board (DSMB) (see section D5 below for more details), which will monitor these events.  
 
For the duration of the study, if a woman discloses that she is in an abusive relationship, she will be 
provided with the battered women’s crisis line for emergencies, referrals to battered women’s shelters, 
and told how to obtain a restraining order. If the partner of the participant is also abusing her child[ren], 
the research staff person involved will let the woman know that she has a choice to make, either she 
herself will call child welfare or the research staff will report the concern. She will be reminded that she 
as the mother is responsible for protecting her child[ren] and if her partner hurts them and she fails to 
call child welfare or the police, she could be charged with neglect and her children could be taken away. 
However, the woman must determine if calling child welfare herself will place her at further risk from 
the abuser. The research personnel involved will also remind the woman that if she calls herself, child 
welfare is more likely to view the woman favorably under these circumstances. The research personnel 
involved will provide the woman with the relevant phone number/s. The research personnel involved 
will let the woman know that let she will be calling child welfare herself because it is the law. This same 
procedure will be followed for any other case of suspected child abuse.   
 
Potential benefits of the proposed research to the subjects and others 
 

 
 
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The potential benefits to women participating in this study include participants’ increased awareness of 
resources for IPV.  Half of the participants in this study will not receive any form of intervention, and 
thus are unlikely to receive any direct health benefit; however, women in both conditions will receive a 
list of referrals and community resources for IPV.  Furthermore, the treating mental health providers of 
women who screen positive for IPV will (with the women’s consent) be provided a print-out of women’s 
survey responses.  Half of the participants will receive a brief intervention designed to increase the 
likelihood of self-change and/or obtaining resources for IPV.  
 
We believe that the risks to participants in this study are very low, particularly given the lack of 
connection between identifying information and data. We believe that the risks that are present are 
justified given the tremendous potential of this research to produce a replicable and low-cost 
motivational intervention that is appropriate for this group. Such an intervention, then, could potentially 
be presented to unprecedented numbers of persons in a way that is financially and logistically feasible, 
potentially leading to beneficial effects for large numbers of women as well as their infants.   
 
4. DATA MANAGEMENT  
 
Adequacy of Sample Size 
The primary purpose of pilot studies is to develop interventions and test feasibility/acceptability of 
interventions and research procedures and sample size guidelines for treatment development from 
Rounsaville and colleagues[76] recommend 15 to 30 participants per cell. A trial of such size is not 
adequately powered to detect between group differences. Although it can be used to suggest the 
potential promise of the intervention and associated effect sizes, we are well aware that these effect 
size estimates have large standard errors, and we primarily aim to find a pattern of results that is 
supportive of the experimental treatment. With baseline data from 50 participants in intent to treat 
analyses (about 25 per condition), we would only have statistical power adequate (.80) to detect large 
effects (d = .81) with alpha of .05. Therefore, our primary emphasis will be on examining the direction of 
effects and the range of effect sizes for differences between conditions. All estimates of effect size 
resulting from this study will include 95% confidence intervals.  
 
Data Analysis: Descriptive statistics will be calculated to summarize baseline characteristics for the full 
cohort and by intervention arm. Quality inspection will be carried out periodically to screen for missing-
ness and data anomalies, and entry error. T-tests and chi-square-tests will be used to compare study 
arms with respect to demographic characteristics, IPV relationship variables, and baseline measures of 
frequency of IPV. Any identified confounders with p ≤ 0.05 will be included in major subsequent 
analyses.  
 
Site Differences:  In the preliminary analyses, participants from the two sites will be compared on all 
demographic and background information.  We will also check for site effects with each specific 
hypothesis by including site as a fixed effect factor in the analysis.  Site main effects and, as appropriate, 
interactions of site with relevant factors will be included.  If site differences (and the interactions) are 
non-significant, this factor will be removed.  Including site as a fixed effect and assuming an equal 
distribution of participants between sites and by treatment within each site will not change the overall 
sample size needed.  However, the study may lack power to detect a site-by-treatment interaction 
unless the difference is large. Powering the study to detect the expected treatment effect separately by 
site is not feasible and would elevate the site-effect to a higher aim as opposed to being a check on the 
analysis[77]. 
 
Aim 1: For hypothesis 1 (primary outcome), the outcome (frequency of IPV) will be analyzed under a 
clustered count regression framework (Poisson or Negative Binomial) with frequency as outcome, and 
time (6-weeks, 3-, 6- and 12 months,), group  (ROSE, control) and time-by-group interaction, with the 

 
 
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baseline (BL) IPV frequency as the primary covariate. A generalized linear mixed models (GLIMMIX) 
approach will be adopted by means of a random subject intercept to account for the clustering within 
each participant. Changes over time within each group will be estimated post-hoc by sliced effects 
derived from the regression model with adjustment for multiple comparisons. In additional analysis, 
reduction in proportion of participants experiencing a binary outcome of IPV ≥ 1 days within the 90-day 
period will be analyzed using a clustered logistic regression with a dichotomous outcome, again with BL 
IPV frequency as a covariate.   
 
Aim 2: Similar analyses will be conducted for the secondary outcomes of positive affect and well-being 
and for perceived emotional support (Aim 2a and 2b). For cost estimation (Aim 2c) see below.   
 
Aim 3: The mediation tests will examine the ability of the proposed mediators, empowerment and self-
efficacy, to account for all or part of the possible main effect of treatment on outcome.  The mediators 
will be assessed at the end of treatment, and outcome will be taken from subsequent time points.  We 
will use the product of coefficients test[78] to determine the magnitude and significance of mediated 
effects.  This method multiplies the parameter estimate for the intervention predicting the mediator 
with the parameter estimate for the mediator predicting the outcome (αβ). We will estimate the 
standard error and 95% confidence interval of αβ by bootstrapping, a re-sampling method that performs 
well when the assumption of normality may not hold.  
 
Missing Data: Missing data will be handled by a weighted complete data analysis, using only complete 
cases after weighting the cases with the inverse probability of being missing. The probability is 
calculated as a function of the variables that are simultaneously associated with the outcome of interest 
and the event of being missing itself.  
 
Power: We calculated the sample size using mean, standard deviation, and within-subject correlation 
estimates for IPV frequency from our R21 study.  IPV frequency was measured by the CAS Total score.  
In our pilot data, we observed participants in ROSE demonstrated a significantly larger change in 
frequency of IPV than the control condition.  The observed between-group effect size for change in IPV 
frequency at follow up was moderate to large: Cohen’s d of 0.59 and 0.68 with and without adjustment 
for baseline score.  Therefore, a more conservative effect size of d = 0.4 was selected for sample size 
estimation.  With four follow up IPV assessments, a within-subject correlation of 0.62, and a standard 
deviation of 20, 74 participants per group are needed to detect an effect size of d = 0.4 for the overall 
intervention vs. control group difference with 80% power at the 5% significance level.  A minimum effect 
size of d = 0.4 will be detectable for the secondary outcomes of positive affect and well-being and 
perceived emotional support.  The secondary outcome measures are reported as T-scores based on a 
normative mean of 50 and standard deviation of 10. With 74 patients per group and assuming an 
observed SD of 10, a 4-point difference in positive affect and well-being or perceived emotional support 
will be detectable. Moderate effect sizes (Cohen’s f for multiple regression = 0.39) for mediated effects 
of the intervention (α and β) will be detectable with 80% power and 74 patients per group[79].   For all 
the outcomes, our proposed sample of 186 should be adequate for detecting small to moderate effect 
sizes. Even assuming the worst-case scenario of up to 20% drop-out in both the ROSE and control 
groups, we plan to recruit 93 participants per arm. 
 
Costs: RAs, interventionist, training, and supervisory time will be priced based on actual salaries, plus 
fringe benefits and overhead (drawn from institutional records), with sensitivity analysis on salaries at 
average wage rates for job titles nationally based on Bureau of Labor Statistics (BLS) annual Occupation 
and Employment Survey (OES) data. Participant time will be priced at the participant’s hourly wage, with 
the state minimum wage used to price time of those who are not presently employed. This pricing 
approach is widely accepted[80]. Because treatment as usual has no cost and the incremental costs of 
treatment are directly measurable, power to detect a difference is not a consideration; the standard 
error of the added costs can be calculated directly and cannot overlap with $0. Data from different years 
will be adjusted to same-year dollars using the appropriate Employment Cost Index from BLS for wages 
and the Consumer Price Index for other costs. The cost-effectiveness ratio will be computed as number 

 
 
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of IPV incidents prevented divided by total cost. To judge the CEA estimate, we will compare it to the 
average cost of an IPV incident. Bid economist Ted Miller is about to submit a manuscript updating IPV 
costs based on recent data and an amalgam of his prior estimates and estimates for the Centers for 
Disease Control[81,82]. Our cost of an IPV includes the quality-adjusted life years lost to the incident, so 
it can be used to estimate a second cost-effectiveness ratio, namely the cost per quality-adjusted life 
year saved. The numerator in that calculation is intervention costs minus the medical and other direct 
(criminal justice) costs of the incident. The IPV costs include lifetime costs related to medical care and 
criminal justice, converted to present value using the 3% discount rate recommended by the 
PCEHM[68]. We will use the Crystal Ball@ add-in to Excel to bootstrap standard errors for the cost-
effectiveness ratios. We also will conduct one-way sensitivity analyses on non-probabilistic parameters, 
notably the discount rate and the wage rates of the clinical staff. NB: a much larger sample would be 
needed to directly track the cost of the IPV incidents. 
 
Data checking  
Data will be collected using computer-based self-interview (ACASI) technology, and will only be 
identified with the study’s ID of the participant. The PI will keep the link between the participant code 
number and name under lock-and-key. The accuracy with which data input matches data output using 
the software will be checked prior to beginning the trial and every five participants thereafter. Although 
no problems are expected given past experiences with this technology, any evidence of errors in data 
recording by the ACASI will result in dropping all participants since the last quality check. Data will be 
checked once per month for out of range values and other quality issues. Dr. Raker will analyze the data 
using SPSS software. 
 
Primary outcomes of the Reach Out for a Safe Environment (ROSE) will be measures of the 
intervention’s efficacy compared to a time, attention, and information matched control condition in 
reducing frequency of intimate partner victimization (IPV) at 6-weeks, 3-, 6- and 12-months after 
baseline assessment.  Secondary outcomes will be measures of the ROSE efficacy compared to control in 
increasing positive affect and well-being and emotional support as well as collecting and measuring the 
cost effectiveness of ROSE to determine if sufficiently favorable. Tertiary aim will be to explore the role 
of theorized mediators of empowerment and self-efficacy on the effect of ROSE.  Effect sizes with 95% 
confidence intervals will be calculated, and outcome data will be analyzed with alpha set at 0.05.   
 
Data acquisition and transmission:  
Data will be collected using computer-based self-interview technology (ACASI), and will only be 
identified with the study’s ID of the participant. The use of computer technology for gathering self-
report data further enhances overall protection. This software (ACASI) utilizes SSL technology for 
encrypting of communications between remote computers and the server itself, is HIPAA-compliant, 
and is currently used in a number of major NIH-funded research studies, including those of the PI. 
 
At the Women and Infants Hospital research site, the link between the participant code number and 
name will be kept in a password protected file on password protected computer.  The accuracy with 
which data input matches data output using the software will be checked prior to beginning the trial and 
every five participants thereafter. Data will be checked once per month for out of range values and 
other quality issues. ACIAS data is password protected and only research personnel will be able to 
access. Results and the response to whether or not she agrees to participate in the study will be 
transferred by secure, encrypted electronic file and downloaded to a secure Women and Infants 
Hospital server. Importantly, no identifying information will be entered into the ACASI.  Dr. Christina 
Raker will analyze the data using SPSS software. Booster session data will be recorded using a credit-
card size digital audio recorder with data encryption capabilities, which can hold hundreds of hours of 

 
 
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voice recordings so that adherence and competence ratings of the booster sessions can be conducted. 
These digital recordings which will be labeled with the study identification number and the booster 
session date and will be transferred to Women and Infants Hospital secure computer server via a secure 
server access. Access to the audio recordings will be limited to research staff. 
 
Data will be destroyed two years after the completion of the study. We expect the study to be 
completed by 2024, so we expect the data to be destroyed in 2026. 
 
5. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS 
 
Frequency of Data Safety Monitoring:  
In this study, we will use the FDA definition of serious adverse events (SAEs). The RAs will report SAEs to 
Dr. Zlotnick immediately. Data and safety of patients will be monitored by the PI. At a weekly meeting at 
Women and Infants Hospital, the PI will review participants’ safety and will present participants’ clinical 
status and adverse experiences. Entrance criteria of all participants will be reviewed at these meetings. 
The PI will ensure that information on participants’ adverse effects are systematically collected and 
evaluated.  
 
Dr. Zlotnick will immediately report any adverse events that are observed to the Women and Infants 
Hospital Internal Review Boards (IRB), DSMB (see below) and NIH. The initial SAE report will be followed 
by submission of a completed SAE report to both institutions and the DSMB (see below). Outcomes of 
SAEs will be periodically reported to NIH. A summary of the SAEs that occurred during the previous year 
will be included in the annual progress report.  
 
An external Data and Safety Monitoring Board (DSMB) will be assembled to evaluate the data and safety 
to women enrolled in the study. The DSMB will consist of 4 senior doctoral-level/MD board members 
who have experience in clinical trials and/or IPV intervention research and/or research with perinatal 
women as the ethical issues involved with a randomized controlled study, as indicated by peer-reviewed 
journal articles in these areas. We do not anticipate any difficulty in recruiting these qualified, 
independent, board members as there is a pool of such researchers at several universities in Rhode 
Island, Michigan, and Massachusetts who have the relevant experience.  
 
The DSMB will convene twice in year 1, once during year 2 to 5 for a meeting. Initially, the Board will 
convene with the PI to review the study protocol and review the guidelines for data and safety 
monitoring. This will include establishing standard procedures for daily (whenever there has been 
contact with a participant) and weekly monitoring by the local internal reviewers (PI and study 
personnel). At each subsequent meeting, the DSMB will evaluate recruitment, the progress of the trial, 
subject retention, data quality and confidentiality. In addition, they will review participants' clinical 
status, rates of adverse events and whether or not there have been any changes in risk to participating 
subjects. This review will ensure that subject risk does not outweigh study benefits. In the DSMB’s 
review of adverse events, if non-serious adverse events are occurring at a significantly higher rate in one 
condition than the other, then the DSMB will make appropriate recommendations for changes in the 
protocol, if needed. If Serious Adverse Events (SAEs) occur at a significantly higher rate in one condition 
than the other, then the DSMB might consider terminating the trial, if changes to the protocol are 
unlikely to address the high occurrence of the SAEs. We do not anticipate that this will occur, because 
we have taken several steps to avoid or protect against the occurrence of SAEs as outlined in the Section 
on Protection against Risk. A report generated from each of these meetings will be retained at each 
study site and will be forwarded to the each study site’s IRBs and to NICHD in the annual progress 
report.  
 
The DSMB will be available to convene outside of the appointed meeting schedule, if necessary, due to 
concerns regarding a particular subject, or due to any troublesome developments in subjects' 

 
 
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experiences during the study. The DSMB will make appropriate recommendations for changes in the 
study protocol, if needed. The safety of participants will be monitored during each contact with study 
participants. Both anticipated and unanticipated adverse events and problems will be formally 
monitored and recorded. Unanticipated serious adverse events or problems will be reported to Women 
and Infants Hospital and University of Michigan IRBs and to NICHD within 24 hours. 
 
6. WITHDRAWAL OF SUBJECTS 
 
Study staff will be trained on understanding the various potential risks of participation in this study, as 
explained above, in the section “Risks and Benefits.” As explained in this section, various procedures will 
be put into place to mitigate these potential risks. However, if when discussing the safety of a subject’s 
participation in the study, study staff decides that stopping a subject’s participation is necessary for 
safety reasons, then study staff will withdraw the subject from the study. As explained in the “Risks and 
Benefits” section, we anticipate that potential circumstances in which this might need to occur include 
breaching of confidentiality, coercion of participants, participant discomfort, the occurrence of study-
related partner violence, and/or social or legal consequences related to study participation. 
 
If participants voluntarily withdraw from the research, study staff will keep the data that has already 
been collected, and will use this data in the study analysis procedures. If a participant is physically 
present when she decides to withdraw from the study, she will be checked in with by research staff, be 
given any relevant informational handouts if it is safe for her to receive and take with her, and be given 
any relevant referrals.  
7. REFERENCES 
1 
The American College of Obstetricians and Gynecologists. (2011). Domestic violence: Frequently 
asked questions. 2012. 
http://www.acog.org/~/media/For%20Patients/faq083.pdf?dmc=1&ts=20120710T1451065788 
2 
Gazmararian, J., Lazorick, S., Spitz, A., Ballard, T., Saltzman, L., & Marks, J. Prevalence of violence 
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