Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Phase: NA
Conditions: Intimate Partner Violence
Sponsor: Women and Infants Hospital of Rhode Island

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Intervention for Battered Sheltered Women With 
Substance Use  
(Open Trial and Randomized Trial) 
 
NCT: NCT02629133 
 
March 15, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Computer-based intervention for battered sheltered women with substance use 
 
Overview 
 
Substance use and intimate partner violence victimization (IPV) are significant and 
interrelated public health problems facing women.  For battered women, the presence of 
substance use increases the risk of re-victimization and the risk of more severe abuse.  
Moreover, given the multitude of competing concerns and the high degree of stress faced by 
battered women during and after their shelter stay, women with prior substance use problems 
are at high risk for substance use relapse. Further, substance use difficulties can compromise 
battered women’s ability to access and effectively use integral community resources, interfering 
with their ability to establish long-term safety for themselves and their children.   
Battered women’s shelters provide emergency shelter to approximately 300,000 women 
and children each year.  A prime time to intervene with battered women might be when they 
enter a shelter and have already initiated a change in their lives.  Thus, a shelter-based 
intervention for battered women that addresses substance use problems might reduce the risk 
of substance use, reduce the risk of future IPV, and improve utilization of substance use 
treatment.  Recent surveys of battered women programs have found that although program staff 
recognizes that substance use problems are common among their clients, these programs have 
limited substance use assessments and interventions in place and only a minority of staff has 
substance abuse training.  Further, a huge challenge for these battered women shelters is the 
lack of financial resources to provide substance use services to their residents, especially with 
current decreases in their federal and local funding and increases in demand for their services.  
A computer-delivered intervention for battered sheltered women with substance use problems is 
a novel approach that can overcome existing obstacles to addressing substance use in battered 
women shelters, particularly time, training, and cost limitations. 
The proposed study will develop and assess an innovative, easily implementable, low-
cost, computer-delivered intervention, the SHE Program (Safe and Healthy Experiences) that 
will address known barriers in early identification and intervention for battered sheltered women 
with substance use issues.  The computer-based SHE Program will be based on motivational 
interviewing a well-defined intervention strategy that has yielded particularly promising results in 
a range of clinical issues and a range of patient populations, including substance using women 
and women with IPV. Motivational interviewing with its non-confrontational and collaborative 
approach and its emphasis on increasing autonomy, self-efficacy, and skill sets is consistent 
with an empowerment model; a highly recommended intervention model for victimized women.  
 
The pilot study aims are to:  
1. Develop our proposed preliminary computer-based intervention, incorporating 
information gained in focus groups.  
2. Perform a small open trial (N = 15) of SHE to assess feasibility of recruitment of target 
population and acceptability of intervention and study procedures. 
3. Conduct a randomized pilot trial in a sample of 60 battered sheltered women who report 
substance use problems within the three months prior to entering the shelter, to 
demonstrate the feasibility of SHE and the acceptability of SHE via participant report of 
ease of use, helpfulness, and overall satisfaction. 
4. Examine preliminary evidence that relative to control condition, the computer-based 
intervention (SHE) will result in improvements in our primary outcomes of substance use 
(heavy drinking or drug using) days over a 6-month post-shelter period and in our 
secondary outcomes of greater use of substance use services (both treatment and self-
help utilization) and reduced IPV severity over a 6-month post-shelter period.  Theorized 

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mediators include readiness to change and self-efficacy for behaviors related to 
substance use. 
 
Background 
Violence against women is a significant public health problem. Intimate partner 
victimization (IPV) is defined as violence by an intimate partner that may involve physical 
altercations (e.g., such as hitting, slapping or kicking), emotional or physical threats, and/or 
forced sexual relations.  IPV is a widespread and significant public health problem.  
Approximately 5.3 million adult women in the U.S. experience victimization annually, which 
results in nearly 2 million injuries and 1,300 deaths[13]; one of the leading causes of injuries to 
women[14].  The degree of morbidity associated with IPV is reflected in the fact that it negatively 
affects eight of the ten leading health indicators identified by the Department of Health & Human 
Services (DHHS[13]).  Estimates of the medical cost burden of IPV range from USD 2.3 billion to 
USD 7.0 billion annually[13,15].  Further, there is accumulating evidence to suggest a significant 
relationship between maternal IPV and maternal child abuse and maltreatment[16,17]. 
In recognition of the significant social problems posed by IPV, battered women shelters, 
which provide physical safety, as well as emotional support, are prevalent throughout the 
country. There are approximately 2,000 community-based shelter programs throughout the US, 
providing emergency shelter to approximately 300,000 women and children each year[18]. 
Considering the number of women who seek help from these facilities and that sheltered 
battered women have already instituted a change in their life, a prime time to intervene may be 
while these women are already seeking help from shelters.  
Substance use problems are highly prevalent in battered women: Lifetime prevalence 
rates for substance abuse or dependence are twice as high for women with IPV than women in 
the general population[19,20] and battered women are 5.6 times more likely to develop a 
substance use disorder compared to women not exposed to IPV[19].  For women in U.S. 
domestic violence shelters, it has been estimated that 42% are substance users[21,22].  
Moreover, given the multitude of competing concerns and high degree of stress faced by 
battered women in shelters and when they leave shelters, women with prior substance use 
problems appear to be at high risk for relapse.  Common theories to explain the strong 
association between these two phenomena have included the self-medication hypothesis, that 
is, IPV victims use substances to cope with the effects of violence[23-26].  Conversely, substance 
use can impair a woman’s judgment or compromise her ability to move to safety (see review[27]).  
A third possibility is that substance use may increase conflict in relationships, leading to violent 
behavior towards the woman, especially if her partner is also using alcohol or drugs[25,28].  The 
pathways linking IPV and substance use are complex.  In general research supports a strong 
bidirectional relationship between these two morbidities.[26,29-32]  A longitudinal study of a 
national probability sample of 3,006 women followed for 2 years identified a cyclic relationship 
where drug use increased the risk of IPV and IPV increased the risk of both drug and alcohol 
use[26].   
Recent research has demonstrated that comorbid substance use increases risk of new 
episodes of violence for women with IPV:  In their comprehensive model of variables associated 
with a battered woman’s risk for future IPV, Foa et al. suggested that negative consequences of 
IPV such as substance use can, in turn, impede a women’s ability to curtail future violence[33].  
Consistently, longitudinal studies have found that substance use is associated with new 
episodes of abuse in battered women[24,34].  Furthermore, drug use is related to increased 
severity of physical partner victimization[35].  Given that cessation of violence is necessary for 
recovery from its traumatic effects, it seems imperative to address victimized women’s 
substance use difficulties. Such an intervention may improve battered women’s ability to 
effectively use resources to help break the cycle of violence and establish their and their 
children’s safety.  

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Why shelter stay is an opportune time to address substance use issues: There is 
consensus among experts that a critical time to provide substance use interventions for women 
with IPV is when they are seeking shelter services, because at these times women are open to 
changes in their lives and identities[36] and most likely to recover from violence and from 
substance use[36,37].  In general, the current literature supports interventions that target both IPV 
and substance use[38,39].  The Substance Abuse and Mental Health Services Administration 
(SAMHSA) in the United States has identified service system integration as a key domain to 
improving services for women with substance use and violence[40] in their lives and have 
highlighted the importance of the need to involve diverse organizations, such as domestic 
violence programs in these integration efforts. 
Despite the need, few battered women shelters address substance use issues among 
their residents. Unfortunately, few battered women shelters address substance use issues, even 
though substance use is extremely prevalent in this population[41].  A survey of battered women 
shelters, found that although the program staff recognize that substance abuse problems are 
common among their clients, these programs have limited substance use assessments and 
interventions in place, and only a minority of staff have training in substance use issues[22].  
Furthermore, a huge challenge for these battered women shelters is the lack of financial 
resources to provide these substance use services to their residents[42], especially with current 
decreases in their federal and local funding and increases in demand for their services[43].  
Our proposed project, will develop and assess an innovative, high-reach, easily 
implementable, low-cost computer-delivered intervention (Safe and Healthy Experiences; The 
SHE Program) that will address known barriers in early identification and intervention with 
sheltered battered women with substance use problems.  Given the number of battered women 
shelters in the country, our proposed intervention, SHE, has the potential to impact a relatively 
large community of women and children and to significantly reduce the suffering associated with 
IPV and substance use.  A computer-delivered intervention, if proven effective, can be widely 
disseminated while maintaining treatment fidelity across sites and may hold promise for other 
IPV populations with substance use issues.  
The overall goal of the SHE Program will be to facilitate self change as well as treatment 
and community resource engagement with respect to substance use issues.  The content of 
SHE will be theory-driven, consistent with a motivational interviewing (MI) model of behavior, 
and consistent with the literature on effective interventions for our target population and targeted 
risk factors.  MI[56,57] is a well-defined intervention approach, has been used to reduce drug use 
among non-treatment seekers[54,58-61], has wide dissemination, and demonstrated efficacy 
across a range of behavioral areas[62] including substance use[63] and across a range of 
populations including high-risk women[64]. Consistent with the Transtheoretical Model (TTM[65]), 
MI utilizes stages and processes of change, evolving readiness and self-efficacy to change. 
Ambivalence about change is considered normative within the motivational interviewing 
framework. The client’s readiness to make changes is not assumed. Instead, an important 
exercise in MI is the exploration of level of readiness to change.  The intervention is appropriate 
for varying levels of readiness to change. MI facilitates internal motivation to change through 
alignment of behavior change with deeply held beliefs, values, and goals.   
The MI model is of particular value for substance using women with IPV in reducing their 
risks because MI has a non-confrontational and collaborative approach, emphasizes increasing 
a participant’s awareness to successful steps towards their own well-being, identifies 
participant’s strengths, and builds upon participant’s successes.  Such an approach is 
consistent with recommendations for brief interventions in substance users[66] and for women 
with IPV[67].  In fact, recently, the World Health Organization[68] has recommended a MI-
consistent approach for intervening with women who have experienced IPV.  Further, a MI 
approach is in keeping with the empowerment model, a highly recommended intervention model 
for women with interpersonal violence[69].  The MI and IPV Workgroup (2010)[67] have suggested 

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that the empowerment model and MI models converge around important principles, such as 
increasing autonomy, self-efficacy, and skill sets. 
   
Summary 
 
Our proposed project will develop and assess an innovative, easily implementable, low-
cost computer-delivered intervention, the SHE Program, that will address known barriers in early 
identification and intervention with sheltered battered women with substance use issues.  
Considering the number of women who seek help from battered women shelters and that 
sheltered battered women have already instituted a change in their life, battered women shelters 
is a prime setting for a substance use intervention.  Further our proposed brief computer-delivered 
intervention is well suited to battered women shelters because it addresses the limited time, 
resources, and training of shelter staff in providing substance use interventions.  Finally, a 
computer-delivered intervention, if proven effective, can be widely disseminated while maintaining 
treatment fidelity across battered women shelters and may hold promise for other battered women 
with substance use issues in other settings. 
 
Methods - General 
Subjects and Recruitment Site 
Participants for the RCT and Open Trial will be recruited from the Women’s Center of 
Rhode Island (WCRI), Sojourner House, New Hope, and Battered Women’s Shelter of Summit 
and Medina Counties.  Participants eligible for the screening portion of the study will be 
residents at the women battered shelter, the Women’s Center of Rhode Island 
(WCRI),Sojourner House, New Hope, or Battered Women’s Shelter of Summit and Medina 
Counties. Shelter staff will inform research staff as new residents are admitted to the shelter. 
The research assistant (RA) will attend house meetings and schedule times to be at the shelters 
when new residents are available and will provide a description of the initial study phase, the 
screening phase (Phase A). Research assistants will also give shelter staff business cards to 
refer clients to the study. Shelter residents will be recruited to participate in a computer-based 
survey to help battered women be healthy. Women who express interest will be given an 
information sheet (used to protect anonymity of those who did not qualify or chose not to 
participate in the full study). The information sheet will indicate that the purpose of screening is 
to find women who may be eligible for a study on risk factors for battered women and will 
describe what is involved with participating in the study. Women who verbally agree to 
participate will be given the opportunity to provide written consent to contact to set up a future 
appointment with the research staff.  Women who refuse to complete screening for the study, or 
if after completing screening refuse to participate in the study, will be asked by the research 
assistant about possible reasons for refusal.  Women who are interested will be screened for 
eligibility using the CIAS software delivered on an easy to use, ultraportable Tablet PC in a 10-
15-minute screener (there will be no identifiers at screening) or a computer in a private setting. 
The use of Audio Computer-based Assisted Self-Interview (ACASI) software to conduct 
screening will maximize identification rates of women at risk for substance use. The screener 
will include a brief series of questions about general health, exercise, and diet. The screener will 
also include basic demographic questions as well as the following well-validated and reliable 
measures for this population: The NIDA-Modified Alcohol, Smoking, Substance Involvement 
Screening Test (NIDA-Modified ASSIST[78]) will be used to assess for alcohol use, illegal drug 
use, and nonmedical prescription drug use in the past three months prior to shelter stay. Those 
who will be fully eligible for the study (and considered as at risk) will be categorized as an at-risk 
drinker and/or at moderate or high risk for substance use based on the NIDA-Modified 
ASSIST[78] criteria for these risk categories. Women who have a prescribed medical marijuana 
card will be excluded from the study. The screener will also include a well-validated, reliable and 
recommended IPV measure. At screening, IPV in the past three months prior to shelter stay will 

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be assessed with the Woman Abuse Screening Tool (WAST[79]). 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[79,80]. It 
has correctly classified 100% of nonabused women and 92% of abused women in a known-
group analysis[79], has good internal reliability[81], and has adequate concurrent validity, even 
with ethnic minorities[81].  Consistent with similar studies, IPV status will be positive if a woman 
obtains a score of 4 or more on the WAST.   
All participants screened will receive a standard health information brochure with further 
information and resources on the health topics mentioned, including a list of local substance use 
treatment referrals and community resources.  Those meeting full inclusion criteria will be asked 
to provide signed informed consent and complete the computer based baseline assessments. 
All participants will be advised to keep their copy of the consent form in a secure location, or to 
discard this form if it is unsafe for them to keep it.   
 
 
Inclusion criteria:  Women who are 18 or older, residents of a battered women’s shelter 
(the Women’s Center of Rhode Island [WCRI],Sojourner House, New Hope, or Battered 
Women’s Shelter of Summit and Medina Counties), who are at risk substance users within the 3 
months prior to entering the shelter, as determined by the screener, the NIDA-Modified 
ASSIST,[78]and endorse IPV within the 3 months prior to entering the shelter, as determined by 
the screener, the WAST[79]  
Exclusion criteria: includes: 1) inability to provide informed consent (e.g., due to florid 
psychosis or other clear cognitive impairment), 2) inability to understand English (understand 
the consent form when read aloud. 3) No endorsement on the baseline TLFB for substance use 
and/or intimate partner violence in the 3 months prior to shelter stay.  
 
Study Procedure 
The research program for this R34 Exploratory Research Award will be divided into three 
phases.  Phase I (the development phase) will consist of manual development, focus groups, 
and the open trial.  During this phase, we will develop our computer based intervention, SHE, 
which will be informed by focus groups.  We will also conduct a nonrandomized trial with  15 
women (open trial) to gain experience with the screening, assessment and intervention, which 
will inform subsequent refinement of protocol and procedures following the guidelines for Stage 
I treatment development[73]. The proposed study will use a sophisticated intervention 
development tool, CIAS developed by Dr. Steven Ondersma,  that has been successfully used 
with perinatal substance using women[11,12].  The Co-I (Dr. Tzilos) has been trained by Dr. 
Ondersma to use this software and successfully developed and tested an intervention to reduce 
alcohol use in an urban setting, for high-risk pregnant women[10].  During Phase II (the pilot 
study phase), we will conduct a two-group, randomized controlled study with a sample of 60 
women endorsing inclusion criteria (see 
Section C.2.3).  Study participants will be 
randomly assigned to either the SHE or a 
time-and-attention-matched control 
condition to assess the feasibility of the 
research design, the acceptability of SHE, 
and to provide some preliminary information 
about the direction of intervention effects for 
substance using days over a 6-month post-
shelter period (primary outcome) and total 
days of substance use services received 
and IPV severity over a 6-month post-
shelter period (secondary outcomes).  
During Phase III (Revision Phase), the 
team (i.e., Drs. Zlotnick, Tzilos, D Johnson, 
Assessment
Personalized
Feedback
Education Advice on 
Substance Use               IPV
Yes?
No?
Ready to Quit?
 Relapse Prevention
Current Substance Use?
Yes
      No
Safety Plan 
Figure 1 Flow of Intervention

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and J Johnson) will review experiences and outcomes for both the open trial and the pilot study. 
Results from this proposal will be used as preliminary data for a fully-powered, larger clinical 
trial. 
The SHE Program will consist of a 50 minute intervention on the Tablet PC.  There will 
be a 15-minute “booster” session on the Tablet PC within 3 weeks after the 50 minute 
intervention session to reinforce the effects of the intervention.  Both sessions will take place in 
a private shelter setting while the participant is a resident of the shelter.  The SHE Program will 
follow the guidelines for brief interventions and contain the recommended elements for brief 
interventions: feedback of risk that is personalized (F), emphasis on personal responsibility  (R), 
non-confrontational advice to change (A), a menu of change options (M), empathy as a 
counseling style (E), and enhancement of self-efficacy (S)—or FRAMES[70].  Motivational 
strategies such as reflective listening and tailored summaries and feedback will be utilized to 
enhance participants’ motivation.   
Some aspects of MI (and FRAMES model) are difficult to translate literally into a 
computer-based intervention (e.g., empathy). The software relies heavily on realistic interactions 
with a three-dimensional animated narrator to mimic a non-judgmental, empathic, and non-
threatening demeanor of a person-delivered brief, motivational interventions. The narrator reads 
each item for the participant, and guides her throughout the process using reflections and self-
deprecating humor. Throughout the development phase of the study, we will receive feedback 
on participants’ sense of autonomy, of being supported and reinforced in their decisions, and on 
the tone of the module.  The software, including the three-dimensional animated narrator, has 
been found in previous research to be well-understood and well-liked by low-income 
women.[10,12]. 
The computerized intervention will begin with a baseline assessment of substance use 
Participants will then receive immediate “profiles” (personalized feedback) based on their 
answers to assessments.  A substance use profile will summarize their typical pattern of 
substance use, their substance use risk level, the known health and societal consequences 
associated with their level of substance use, and the negative consequences they identified as 
resulting from substance use.  Next there will be an education component that will deliver facts 
about the woman’s substance use, and associated risks for the woman, including partner 
substance use; the bidirectional relationship between substance use and IPV; and risks of 
untreated substance use such as increased risk of IPV.   
A limitation of some clinical trials of MI-based interventions for substance use and most 
clinical trials of behavioral interventions for IPV] is the imbalance in intensity of sessions 
between the experimental intervention and control group, which makes it difficult to determine if 
intervention differences are attributable to differences in attention between the conditions or to 
the “active ingredients” of the intervention.  Because the proposed non-MI control condition will 
be matched for duration, level of interactivity, and mode of delivery and has been shown to be a 
credible control condition[10], it will provide a reasonable test of the effect of the SHE Program. 
Furthermore, our control condition will have no overlapping content with the SHE Program.  
Finally, since both conditions will be computer-based of similar duration, the blinding of research 
staff to experimental condition will be facilitated. 
There are no standard or universal procedures in place for screening and brief 
interventions for women with IPV and substance use issues.  Like most battered women 
shelters[41], WCRI does not conduct any formal or systematic substance use-related 
assessments or interventions for their residents, besides appropriate referrals for substance use 
treatment, if requested, or if needed (i.e., resident discloses difficulties or is found to be using 
alcohol or drug during her shelter stay).  All participants who consent for the RCT study (and 
open trial) will receive a list of appropriate substance use treatment referrals and community 
resources (e.g., NA, AA) and a brochure on alcohol and drug risks.    
The intervention will be tailored on the current substance use status of each participant 
(see Figure 1). Computer software can easily deliver such a bifurcated treatment approach – 

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such an intervention design is consistent with evidence that motivational approaches may work 
best with less motivated individuals[71].  The intervention will contain language referring to either 
substance use in general (past or present behaviors and beliefs) or current substance use, and 
will not assume current substance use.  For women who state that they have already quit (see 
“No” in Figure 1), the three-dimensional animated narrator will present a section that will focus 
on how they can remain abstinent now and after they leave the shelter (Relapse Prevention).  
An example in this section will include if the woman decides to return to her abuser, how 
avoiding using with her abuser could decrease her risk for abuse and for subsequent substance 
use.  These women (i.e., those who have already quit) will have the option to create a 
personalized Safety Plan, and can select from a menu of potential personal change goals (i.e., 
maintain their change) and/or optionally, they can enter their own change goals in free text.   
Women who endorse current substance use will be asked about their interest/readiness 
in quitting their substance use (“Ready to Quit?”) leading to a bifurcated treatment response 
such that those participants reporting a goal of immediate abstinence will move more quickly to 
a section consistent with primary goal-setting for substance use reduction. This arm will follow 
closely the guidelines established in previous intervention studies[72] which will include 
components of a quit contract and will assist the woman in identifying specific goals and a 
timeline for reaching these goals.  These participants will have the option to create a 
personalized Safety Plan that will include the specific goals that the women have identified 
and/or optionally, can enter their own change goals in free text. Some example of goals will 
include attending AA or NA, attending substance use treatment, speaking to shelter staff about 
coordinating substance use treatment, planning for support groups after leaving the shelter such 
as IPV support groups.  For the remaining participants who report not being ready to quit at this 
time, the narrator will present sections including pros and cons, feedback, and optional goal-
setting.  Specifically, in the pros and cons section, the narrator will normalize feelings of 
ambivalence about substance use, noting that most people can identify sides to their use that 
are both positive and negative. For example, the narrator will first ask for the good things about 
substance use and provide a checklist in which the participant endorses as many pros as they 
would like. The narrator then notes that for many people there are also some “not so good” 
aspects to substance use, and presents another checklist in which the participant endorses as 
many cons of substance use as they would like. Then the narrator reflects back to them the 
specific pros and cons that they selected and notes that feeling two ways about one’s substance 
use is quite normal. For example, the narrator would say, “You really seem to feel two ways 
about this. On the one hand, you like the way that smoking marijuana helps you relax when you 
have reminders of the abuse. But at the same time, it is only a temporary fix for your problems.”  
In the feedback section, the narrator will first present participants with normative feedback 
regarding their typical substance use using an easy-to-read graphical display and clear 
description of what the feedback means. This feedback includes key pieces of information: how 
much the participant reported using, how much they think most other women use, and how 
much of it other women actually use. Normative feedback is followed by feedback with the 
specific negative consequences that the participants reported having experienced as a result of 
their substance use. The narrator will then elicit brief elaborations of negative consequences 
using simple questions keyed to each type of consequences. For example, if a woman 
endorsed the item regarding health problems as a result of substance use, the narrator could 
ask, “What sorts of health problems have you had?” and provide a checklist of possible 
response. A follow up question could then ask the participant to choose ways in which their 
health could be improved if they did decide to make a change. There will be a section that will 
provide feedback on each participant’s self-reported readiness to change with regard to 
substance use. In the optional goal-setting section, the narrator will begin by briefly summarizing 
the state of each participant’s ambivalence regarding her substance use, and the factors pulling 
her in either direction. The narrator then asks if she would like to set a change goal. If she does 
not wish to do so, the narrator reflects her lack of readiness at this time and elicits information 

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regarding what signs would tell the participant that she did need to change.  If the participant 
does wish to set a change goal, the program will guide her through a brief change plan process. 
In this process, the participant will be asked when, why, and how she would like to make a 
change regarding her substance use and be given the option to create a personalized Safety 
Plan that incorporates the changes the woman has identified and/or any other changes she 
would like to add in free text.  All SHE participants will be provided with an optional one-page 
print-out of the Safety Plan as a resource.   
Booster session: Within three weeks of the intervention, women will complete a 15 
minute computerized booster session in which they will review the relevant components of the 
intervention session for each woman (e.g., pros and cons, feedback, and goal-setting) and their 
own personalized safety plan.  The booster session will bolster the effects of the intervention.  
Women will be given the option to revise their personalized Safety Plan, and can select from a 
menu of potential personal change goals; they can enter their own change goals in free text.  All 
participants will be provided with an optional one-page print-out of the Safety Plan as a 
resource.  
 
Methods - Open-Pilot Trial 
In Month 7, we will begin recruitment for the nonrandomized trial with 15 women to gain 
experience with the screening, assessment and intervention, and to inform subsequent 
refinement of protocol and procedures.  After the baseline assessments have been completed, 
the study participant will complete the SHE Program (an initial session plus booster session 
within three weeks prior to leaving the shelter) and complete 3- and 6-month follow-up 
assessments. After the completion of the SHE Program, participants will complete a computer 
based intervention specific End-of-Intervention Questionnaire, which will address participants’ 
perceptions of the helpfulness of each intervention component, including timing and length of 
the sessions and their level of comfort with research procedures. Participants will discuss their 
responses at an end-of-intervention exit interview with Dr. Zlotnick or a trained research 
assistant to aid in intervention revisions.  
 
Methods - Randomized Pilot Trial 
 
Women who are residents of a battered women’s shelter (the Women’s Center of Rhode 
Island [WCRI],Sojourner House, New Hope, or Battered Women’s Shelter of Summit and 
Medina Counties), who are at risk substance users within the 3 months prior to entering the 
shelter as determined by the screener, the NIDA-Modified ASSIST[78], and endorse IPV within 
the 3 months prior to entering the shelter as determined by the screener, the WAST[79] (Phase 
A) will be eligible for the RCT (Phase B).  Phase B will use a two-group, randomized, controlled 
design with 60 shelter residents.  After eligible participants consent to participating in the RCT 
and complete the computer-based baseline assessments the (computer) narrator will “flip a 
coin” and randomly assign participants to the SHE Program (an initial session plus booster 
session within three weeks after the initial session) or to the time and attention matched control 
condition (an initial session plus a booster session within three weeks after the initial session; 
both consisting of video viewing of popular shows and preference ratings).  Next study 
participants will complete their assigned computer-based intervention.  There will be 3- and 6-
month post-shelter computer-based follow up assessments (see figure 2 below).   
 
Figure 2: Methods for Phase B 
Screening
Randomization
Baseline 
Assessment-
Intervention 
Condition
Baseline 
Assessment-
Control 
Condition
2 Week
Booster Session
3-Month Follow-
Up Assessment
6-Month Follow-Up 
Assessment
Consent

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For those who have completed Phase A (i.e., the screener) and who are eligible (i.e., 
endorse at risk substance use and IPV in the three months prior to shelter stay), research staff 
will inform them about the clinical trial, explain the informed consent process, and explain the 
study procedures.  Refusal rates will be recorded and residents who refuse participation will be 
asked to provide their reasons for refusal.  Women who provide informed consent will be given 
the computer again, and complete an approximately 20-30-minute baseline assessment using 
the ACASI software.  The informed consent process, the computer-based baseline 
assessments, and computer-based sessions for both conditions will be conducted in a private 
space at the shelter.  Follow-up assessments will be conducted in a private room or at a location 
that is a convenient location for the woman and one that will provide a confidential, safe, and 
comfortable environment for the participant. If a follow-up assessment is being conducted at a 
woman’s home, the research team may ask her if she will allow the research team to use her 
internet connection to run the computer program on the Tablet PC. If a participant does not 
have internet access or does not allow the researchers to access her internet connection, the 
research team will use our own portable air card for wireless internet connection. Participants 
will be reminded that if they do not wish to use their internet connection, they can still participate 
in the study. All participants in this study will receive care as usual from shelter staff; no 
screening, referral, or counseling will be withheld in any way at any time.  
 
Randomization  
 
After the screening has been completed (Phase A), for those who are eligible who have 
provided informed consent, and who have completed baseline assessments, the (computer) 
narrator “flips a coin” and randomly assigns participants into control vs. SHE Program conditions 
(Phase B).   
 
The SHE Program condition 
 
SHE participants will receive a 50-minute intervention after randomization and a 15-
minute booster session with three weeks after the initial session on the Tablet PC. (The 
research team may modify the length of intervention sessions based on open trial feedback). 
The computer-based intervention and booster session will be conducted in a private space at 
the battered women’s shelter during participants’ shelter stay.  SHE will take place during 
participants’ shelter stay because women are more likely to initiate changes when they are in a 
supportive environment.   
 
Control condition 
 
Control group participants will complete the same assessment measures. After 
randomization, participants in the control condition will receive a 50-minute session and a 15-
minute booster session within three weeks after the initial session on the Tablet PC, which will 
comprise of the viewing of popular entertainers/shows videos. See above for description of the 
control condition.  This condition will control for time spent on the computer-based intervention, 
maintain blinding of research assistants, and mimic the interactivity of the computer-based 
intervention condition.  The control condition will be conducted in a private space at the shelter 
during participants’ shelter stay.  
 
Feasibility   
Our target enrollment of 60 women within an 18 month period appears to be feasible 
because there are high rates of substance use difficulties among battered sheltered women.  
Researchers estimate that about 42% of residents of battered women shelters are substance 
users[21].  Furthermore, we found in our study of a treatment for battered sheltered women with 

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posttraumatic stress disorder, where women with active substance dependence were ineligible 
and less likely to be referred to the study, 24% (n = 27) of participants assessed at baseline (n = 
112) still met full criteria for a substance use disorder in the last 3 months.  Moreover, there is a 
relatively high volume of women residents at our recruitment site, and our use of a computer-
delivered screener should facilitate disclosure[47]. 
 
 
Measures  
 
Participants who screen positive for substance use problems and IPV within the 3 
months prior to shelter stay during screening will complete an approximately 20-30 minute 
baseline assessment session on the Tablet PC.  Screening measures for at risk substance use 
and IPV are the same as the open trial and include the NIDA-Modified ASSIST[78] and the 
WAST[79], respectively.  Most measures for this study will be completed by participants using the 
Audio Computer-based Assisted Self-Interview (ACASI) software and the Tablet PC.  If there 
are any technical issues with the Tablet PC, paper copies of the same measures will be offered 
to participants to complete.  Like the data completed on the tablet, the paper versions of the 
measures will be de-identified data.  Measures will be administered to both groups of women at 
baseline (i.e., after screening and consent) and at 3- and 6 months after shelter discharge.  The 
baseline battery is designed to minimize assessment with the control group in order to take into 
account growing concerns regarding the motivational properties of assessment, leading to 
substantial Type II error in other MI-based intervention studies[94,95]. 
Demographic measures:  All participants will complete demographic information, 
including age, race, ethnicity, educational level, marital status, occupation, employment (status, 
# hours per week), socioeconomic status, etc.  See Table 1 for the time schedule for the study 
assessments.  
Acceptability: Satisfaction with CIAS Software Scale (SSS) assesses participant 
satisfaction on items tapping on likeability, ease of use, level of interest, and respectfulness[12].  
Participants will also complete the well-studied 8-item Client Satisfaction Questionnaire-Revised 
(CSQ-8-R) to assess satisfaction with the intervention[96]. These scales will be administered 
after each computer-based session (i.e., initial session and booster session) and administered 
to both conditions.   
The following measures will be administered to both groups of women at baseline and at 
3- and 6- months after leaving the shelter.  
Primary outcome measures: Alcohol and Substance use: Timeline Follow-Back (TLFB)-
modified computer version[97-99] has yielded comparable results to face-to-face interview 
administrations. The computer-based TLFB will assess drug use and heavy drinking (4+ 
standard drinks) days for the past week and the past 90 days from entering in the shelter. The 
TLFB will be done in person as well. For primary analysis, days using drugs and heavy drinking 
days will be combined to create a single variable that reflects the total number of days that 
women used drugs or had 4+ drinks.  The TLFB has excellent reliability[100], and is sensitive to 
change as used in this study[101,102].  (We will not collect collateral (i.e., from a significant other) 
reports of subjects’ use to corroborate yes/no use of substances because this could pose a risk 
to confidentiality for the participant, who might be particularly vulnerable if she is experiencing 
IPV).  To provide objective corroboration of self-reported drug use, hair sample testing 
(Psychemedics, Inc) at the 3- and 6-month will be obtained to give an approximately 90-day 
window of evidence for cocaine, marijuana, amphetamine, or opiate use. 
We will report correlations between self-report and biological measures of substance 
use.  Breath alcohol tests will be conducted at each follow-up assessment (i.e., at the 3 months 
and 6 months periods in order to insure that the client has consumed no alcohol prior to the 
assessment (breath alcohol content < .02). If the participant has been consuming alcohol, the 
assessment will be rescheduled. Urine drug screen results will also be reviewed to corroborate 

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self-report data at the 3- and 6- month assessments. Urine drug screens will use 
theCLIAwaived, Inc. Instant Drug Test Cup-7 Panel Cup (ICTC), be unobserved, and test for 
benzodiazepines, cocaine, methamphetamine, methadone, opioids, oxycodone, and THC.  .  
Secondary Outcomes: The Treatment Services Review (TSR)[103] will be used to assess 
total days of substance use services (both treatment and self-help utilization) received (including 
outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are 
reaching out to access recovery-related resources.  At baseline and at each follow-up point, the 
TSR will assess total days of substance use services received for a 90 day window. 
 IPV: The Composite Abuse Scale (CAS) is a widely used self-report of behaviors scale 
with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and 
harassment. The CAS has recently been published in the Centers for Disease Control and 
Prevention compendium of intimate partner violence measures[120].  It consists of 30 items 
presented in a six point format requiring respondents to answer “never”, “only once”, “several 
times”, “monthly”, “weekly” or “daily” in a twelve month period [121].   
The Cyber Stalking Scale measure is a 6 –item measure and assesses the use of 
technologies in stalking and harassment.  
Safety Behavior Checklist (SBC)[122,123] has 15 items that assess the use of strategies 
suggested to keep victim safe (e.g., hiding money and extra clothing). 
 
Theorized Mediators: The Confidence Ladder will be used to assess the participants’ 
levels of confidence regarding their ability (self-efficacy) to change and abstain from 
substances.  Readiness Ruler will be used to assess the degree to which participants’ are ready 
to cut down or quit alcohol or drugs.  
Women who participated in the SHE intervention will complete a computer-based measure at 
the 3- and 6-month follow-up assessment to determine the extent to which participants achieved 
their goals on their personalized plan; an indication of the degree to which the SHE intervention 
had an impact on behavioral change.  This measure will follow a similar format to the 
Effectiveness in Obtaining Resources Scale, which assesses battered women’s effectiveness in 
obtaining various resources. 
At follow up, if a participant is unable to meet in-person to complete the assessments 
(e.g. participant has moved out of state), she will be given the option of participating in the 
assessment over the phone. Phone sessions will consist of the research assistant administering 
all the follow up assessments listed above via a phone session, with the exception of 
breathalyzer, urine, and hair sample testing.  
 
Table 1:  Schedule of Assessments: 
 
Measure 
Intake 
Post 
intervention 
and booster  
3-months 
after shelter 
discharge 
6 months after 
shelter discharge 
Demographics 
X 
 
 
 
Timeline Followback 
X 
 
X 
X 
Hair Sampling Testing 
 
 
X 
X 
Breath Alcohol Testing 
 
 
X 
X 
Urine Drug Screening 
 
 
X 
X 
The Composite Abuse Scale 
X 
 
X 
X 
Safety Behavior Checklist 
X 
 
X 
X 
Treatment Services Review 
X 
 
X 
X 
Client Satisfaction Questionnaire  
 
X 
 
 
Satisfaction with CIAS Software Scale 
 
X 
 
 
Readiness Ruler 
X 
 
X 
X 

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Confidence Ruler 
X 
 
X 
X 
Cyber Stalking Scale 
X 
 
X 
X 
 
Retention  
 
The PI has had high retention rates (+ 85%) in treatment trials involving difficult-to-follow 
populations (e.g., substance using women with interpersonal violence and women with IPV. 
Furthermore, our prior research with battered residents leaving shelter, our follow up rates have 
been 82% retention at 6 months post-shelter and 80% at 9 months post shelter.  The current 
study will employ several approaches that we have found helpful in achieving these low attrition 
rates, including staff’s strong relationships with participants, efforts to value and appreciate the 
women’s participation in the study, and frequent personal contact with the women for the 
duration of the study. Research staff calls women to remind them of their appointments and 
maintain a list of two other people who will always know where the participant resides. We can 
contact the women through private message on Facebook via a generic Facebook page of “She 
A. Smith” with no information about who we are or what we do.  Dr. Zlotnick has used this 
retention strategy safely and successfully in a study of women residents of a battered women’s 
shelter in Ohio. Transportation is provided as deemed necessary to complete assessments. 
Further, compensation for participants’ time for assessments helps facilitate retention. Finally, 
Rhode Island’s small size and population stability (residents rarely move out of state) also 
facilitate participant retention.   
 
Limitations  
The limitations of this study include: potential issues related to disclosure of sensitive 
information, the use of self-reports, assessment reactivity and effect on measured outcomes, 
the inclusion of only English-speaking participants, and generalizability of study results to other 
substance using populations. 
 
Potential risks  
There are four potential low- to moderate-risks to subjects associated with this research 
project: 
Breach of confidentiality: Assessment procedures could reveal sensitive information 
about participants’ substance use 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 
participation (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 and substance use 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 participation in the research project.  
Social or legal consequences: Possible social or legal consequences due to revelations 
of IPV. 

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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 Women’s Center, Sojourner House, New Hope, or Battered Women’s 
Shelter of Summit and Medina Counties, and any other follow-up 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. Further procedures to minimize 
each of these risks are described below. 
 Recruitment and informed consent:  Shelter staff will inform research staff as new 
residents are admitted to the shelter. The RA will attend house meetings and schedule times to 
be at the shelters when new residents are available and will provide a description of the initial 
study phase, the screening phase (phase A). Shelter residents will be recruited to participate in 
a computer-based survey to help battered women be healthy.  Women who are interested in 
participating in the screener will receive an information sheet, which will be summarized (and 
read for those who prefer this) in a private setting. The information sheet (used to protect 
anonymity of those who did not qualify or chose not to participate in the full study) will indicate 
that the purpose of screening is to find women who may be eligible for a study on health risk 
factors and will describe what is involved with participating in the study.  Those women who 
verbally agree to participate will complete the 10-minute screener (there will be no identifiers at 
screening) using the CIAS software delivered on an easy to use, ultraportable Tablet PC.  
Women meeting study screening criterion (i.e., endorse substance use in the three months prior 
to shelter stay) will be given the opportunity to provide informed consent for the clinical trial, in a 
private setting. Research staff will carefully explain all aspects of the study to a potential recruit, 
including the risks and benefits and obtain participants’ written informed consent. Recruits will 
be informed of the intervention commitment, amount and general types of assessments, and the 
follow-up procedures. 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 reminded that they are not required to participate in the study and that they will receive 
the standard care provided by the Women’s Center, Sojourner House, New Hope, or Battered 
Women’s Shelter of Summit and Medina Counties regardless of whether or not they choose to 
participate.  Participants who give their consent will sign a copy of the document and will be 
given a signed copy of the informed consent document. Women who refuse to participate in the 
clinical trial will be provided referral information. 
The use of computer technology for gathering self-report data further enhances overall 
protection. Data will be encrypted in transit between user and server. Importantly, no identifying 
information will be entered into the ACASI. Given the sensitive nature of this research, the 
computer software will simply generate a code number for each participant. Additionally, all 
forms with participant information will be marked with a code number and not with the 
participants’ name. The PI will keep the link between the participant code number and name 
under lock-and-key. Any information about a participant will never be released to outsiders 
without their explicit consent, except in the event of abuse of children/elderly/handicapped 
(report to the State of Rhode Island) or a medical emergency, when pertinent medical 
information will be given to the medical personnel caring for the individual.  
 
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.  
A Certificate of Confidentiality will be obtained from the National Institutes of Health prior 
to the commencement of research. The purpose of this certificate is to protect the identity of 
research subjects participating in studies that collect sensitive information. Potential participants 

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will be informed that a Certificate of Confidentiality has been obtained for this project and that 
this certificate will protect the investigators from being forced to release any research data in 
which participants can be identified, even under court order or subpoena, although this 
protection is not absolute. 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. Dr. Zlotnick has successfully 
used this approach in previous studies involving substance using women and women with 
intimate partner violence (IPV). 
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.  Moreover, clinical backup will be provided during all assessments and during 
the intervention phase of the study by a licensed clinician to help facilitate any stabilization and 
referral process for participants who decompensate during assessment procedures.  The need 
for additional services will also be monitored during all follow-up assessments.   
To further address possible distress due to sensitive items, participants will be asked by the 
computer program if anything the computer has asked or done is making them feel upset right 
now. The computer program will notify the research team at completion of the screening, 
intervention session, or assessment, if any participant answers yes to this question. (Note that 
the computer program will not provide details regarding any answers, only that there is a need 
to follow-up with the participant verbally to evaluate the need for assistance).  At a minimum, all 
participants indicating some distress will be given a list of referral options. For the duration of 
the study, women who report significant homicide or suicide risk will be immediately referred for 
evaluation for psychiatric admission at a local emergency department and if in the shelter, the 
appropriate staff will also be notified.  All research personnel (i.e., interventionists, research 
assistants) will be trained in the protocol for homicidal or suicidal risk and research procedures 
for these situations.  A licensed clinician will be available at all times by pager.  Research staff 
will contact the licensed clinician if there are any safety concerns.   
Suicide or homicide risk:  All subjects will be closely monitored for significant suicidal 
and homicidal risks.  During any phase of the study, if study interventionists, supervisors, or 
research staff judge that a subject is a significant suicide risk, the subject will be evaluated 
immediately by emergency room clinical staff at the closest hospital.  If a subject reports active 
suicidal or homicidal ideation or plan during the SHE booster session, they will be evaluated 
individually by the study interventionist.  If the suicidal or homicidal plan warrants immediate 
action, the interventionist will initiate voluntary or involuntary hospitalization.  A licensed clinician 
will be available at all times by pager.  Research staff will contact the licensed clinician if there 
are any safety concerns.   
Referrals for additional care:  All participants screened will receive a standard health 
information brochure with further information and resources on the health topics mentioned in 
the screening survey including a list of local substance use treatment referrals and community 
resources. Likewise, all participants who consent for the open trial or RCT study will receive a 
list of appropriate substance use treatment referrals and community resources.  At any follow-up 
assessment, any participant who reports heavy drinking or the use of any illegal substances will 
be referred to appropriate treatment.  Likewise, at follow-up assessments, any participant who 
reports current intimate partner violence (IPV) will be provided with information on IPV and a list 
of local IPV resources.   
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.  
All phone calls will go through a confidential research line where the number is blocked. This 
line is answered, “Women and Infants Program,” and partner violence is never mentioned. 

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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. Follow-up 
interviews will be scheduled at a safe location. 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. 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 will be updated monthly to determine if the contact information they 
previously provided is still accurate and safe. 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., interventionist, research assistant) will be able to call the PI 
for advice on any case where there is a concern for the safety of the respondent and the PI will 
be available at all times by pager.   
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 assessments (3- and 6-month) about any 
occurrences of hospitalizations for medical, psychiatric, or substance use issues or emergency 
room visits, and whether or not any of these events were related to IPV in order to better gather 
information regarding any potential serious adverse events.  These events will be reported to 
the Data Safety Monitoring Board (DSMB). 
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 children, the research staff person involved will let the woman know that she 
as the mother is responsible for protecting her children 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. The research staff will encourage the woman to call child welfare herself as 
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 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 
The potential benefits to women participating in this study include close monitoring of 
participants’ alcohol and drug use as well as participants’ increased awareness of community 
resources for IPV and alcohol and drug-related issues. Half of the participants in this study will 
not receive any form of an “active” intervention, and thus are unlikely to receive any direct health 
benefit; however, women in both conditions will receive a list of local substance use treatment 
referrals and community resources.  Half of the participants will receive a brief intervention 
designed to increase the likelihood of reductions in substance use and IPV, self-change and/or 
obtaining community resources for alcohol and drug use.  
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 

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and logistically feasible, potentially leading to beneficial effects for large numbers of substance 
using women with IPV.   
 
Importance of the knowledge to be gained. An exploratory approach towards the 
development of an effective brief computer-based intervention for sheltered battered women 
with substance use problems could increase the likelihood of these women accessing services 
for their substance use difficulties and reducing their substance use and IPV severity. Further, 
there is promising evidence that the application of brief interventions to substance using women 
offers substantial benefits to the woman. The paucity of research targeting substance use 
problems with battered sheltered women and the potential success of implementing a computer-
based brief intervention in this population invites the proposed research investigation. 
  
Data Analysis:  
  
For this treatment development grant, assessment of feasibility and acceptability of the 
intervention and research procedures is the primary goal. Nonetheless, pilot data can be used 
to demonstrate whether the effects of treatment look promising across a set of outcome 
variables, to begin to examine distribution of outcome variables and ranges of correlations 
among variables across time to inform future analytic strategies, and to suggest, in concert with 
results from larger scale clinical trials in related fields, the range of effect sizes that would be 
reasonable to expect in a future trial.  As a result, we will obtain the between treatment condition 
effect size estimates at each assessment (e.g., Cohen’s d or h) as well as the correlation 
between the same dependent variable at adjacent assessments.  We anticipate we will have 
complete data on approximately 41 participants.  Sample size guidelines for treatment 
development from Rounsaville et al.[114] recommend 15 to 30 participants per cell.  Given that 
group means begin to stabilize by around 15, we believe a sample of ~20-21 in each condition 
should provide some information relevant to demonstrating potential promise for the 
intervention.      
 
Primary analyses will be intent-to-treat (using data from all treatment enrollees).  
Secondary completer analyses (including only subjects who attend at least the computer-based 
session) will also be conducted.  Analysis strategies used (hierarchical linear modeling [HLM]) 
can accommodate missing data, and can be used in a sample of 41 with a highly constrained 
covariance structure.  Outcome variables may be transformed to improve normality if needed.  If 
any outcome variable is too zero-inflated to be normalized through transformation, it will be 
analyzed with logistic regression or generalized estimating equation techniques in this small 
pilot study, and then with zero-inflated Poisson or negative binomial regression techniques in 
the subsequent fully-powered study. We will compare rates of missing data across conditions.  
Per recent clinical trials guidelines[115] analyses will adjust for baseline levels of dependent 
variables but will not test or adjust for any other baseline differences between conditions that 
result from randomization. Participants’ data will be directly exported from CIAS to a database 
immediately after each participant session. CIAS and ACASI data will be backed up daily and 
checked once per month for out of range values, missing data, and other quality issues. 
 Study Feasibility and Intervention Feasibility/Acceptability.  One of the primary goals of 
a treatment development study is to demonstrate the feasibility of the proposed treatment and of 
the study and recruitment methods[4].  As a result, we will assess the feasibility of the research 
procedures by examining study recruitment and refusal rates, participants’ willingness to be 
randomized, follow-up rates, and range of responses to study questionnaires.  We will assess 
the feasibility and acceptability of SHE by examining rates of intervention attendance, and rates 
of intervention completion (both the intervention session and booster session for both 
conditions).  For our rates of session completion, we expect at least 80% will complete both 
baseline and booster sessions based on our good attendance rates in our other IPV intervention 
studies[1,87,116].  We will also examine reasons for termination for consistent patterns.  We will 
examine the acceptability of both SHE and control conditions using data from Satisfaction with 
CIAS Software Scale[12] (i.e., an average score of 4 out of 5 on the CIAS satisfaction scale; at 

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least highly satisfied and engaged with software) and CSQ-8-R[96] (i.e., above the average score 
of 27 on the CSQ-8-R)(see Section C.3.11).  We will examine mean, mode, and median scores.    
     
Other Primary Outcomes. (1) In addition to examining pre-post changes in the 
intervention condition, we will calculate the effect size and 95% confidence intervals for number 
of substance using days [including drug-using and heavy drinking days (4+ standard drinks)]. 
Exploratory tests for differences between conditions will use HLM, with using days in the 6 
months prior to intake as a covariate. (2) Secondary Outcomes.  We will examine pre-post 
changes in the intervention condition, and calculate between-groups effect sizes and 95% CIs 
for (1) total days of treatment received measured by the TSR, and for (2) reduction in IPV 
severity using the CAS. IPV severity will be operationalized as the sum of the number of 
abusive acts endorsed on the CAS; a scoring method found to provide a valid measure of abuse 
severity IPV[117].  For exploratory tests for differences between conditions, we will use HLM with 
baseline scores as covariates.   
Assessment of processes and individualized treatment response.  This R34 treatment 
development study is underpowered to explore mediation effects (MacKinnon’s mediation power 
= 16%); a subsequent R01 will test the hypothesis that improvement in readiness to change and 
self-efficacy variables partially mediate the effects of SHE on our primary outcomes.  Similarly, 
though a full test of moderation will be conducted in a subsequent R01, we will explore potential 
predictors of intervention response including IPV severity and baseline substance use severity, 
and will conduct preliminary examinations of large minority differences in this study.   
 
Phase III Refinement of SHE 
 
Based upon our experience during the Development and Trial Phase, evaluation of the 
program, and feedback from participants, the Investigator Team will revise the intervention. 
These revisions and the published qualitative and quantitative results of this study will represent 
the final products of this R34 and will be used in conjunction with information regarding the 
recruitment methods and retention of participants in the application for an R01 to evaluate this 
new intervention for our target population.  
 
 
 
Figure 3: Timeline for R34 Research Activities   
 
Year 1 
Year 2 
Year 3 
1 
 
7    12 
 
 
 
 
28 
 
 
36 
Develop intervention; conduct 
focus groups & qualitative 
analysis 
 
 
Conduct open trial, refine 
intervention  
 
 
 
 
 
Recruit, randomize, & intervene 
 
 
 
Collect post-release & follow-up 
assessments 
 
 
 
Analyze data, prepare 
manuscripts, make final manual 
and scale revisions, write R01 
 
 
 
Economic Considerations: 

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Participants will receive gift cards and money (total equivalent up to $120) for their 
participation. Participants will receive a $5 gift card for completing screening, $30 for completing 
the baseline session and assessment before leaving the shelter, and $30 for 3 and 6 month 
follow-up assessments after leaving the shelter. Participants will also receive $5 for completing 
the booster session. Participants will receive an additional $10 for completing the hair sample 
testing. 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 will be reimbursed to 
the study participants at a rate of $10 per hour for up to a 2 hour time period when applicable. 
 
Safety Monitoring Plan: 
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 substance using 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 and Massachusetts who are unaffiliated with Brown, who have the relevant 
experience.   
The external DSMB will convene twice in Year 1, and then once during Year 2 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 this meeting and 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 of Risk. A report generated from each of these 
meetings will be retained at the study site and will be forwarded to the hospital’s IRBs and to 
NICHD. 
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' 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 the hospital IRB and to NIDA within 48 hours. 
In this study, we will use the FDA definition of serious adverse events (SAEs). RAs will 
report SAEs to the PI immediately.  Data and safety of patients will be monitored by the PI.  At a 
weekly meeting, 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 

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meetings. The PI will ensure that information on participants’ adverse effects are systematically 
collected and evaluated.   
    Dr. Zlotnick (or other key personnel if necessary) will immediately report any adverse events 
that are observed to the Women and Infants Internal Review Boards (IRB) and NIDA. The initial 
SAE report will be followed by submission of a completed SAE report to both institutions. 
Outcomes of SAEs will be periodically reported to NIH (NIDA). A summary of the SAEs that 
occurred during the previous year will be included in the annual progress report.    
 
 
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