Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
Phase: NA
Conditions: Alcohol Use Disorder, Post Traumatic Stress Disorder
Sponsor: University of Massachusetts, Worcester

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1. TITLE 
Piloting Signs of Safety: A Deaf-accessible Therapy Toolkit for AUD and Trauma 
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
The current study is funded by the National Institute on Alcohol Abuse and Alcoholism 
(NIAAA). 
 
4. OBJECTIVES* 
The U.S. Deaf community – 500,000+ Americans who communicate using American Sign 
Language (ASL) – experiences nearly triple the rate of lifetime problem drinking compared to 
the general population and twice the rate of trauma exposure. Although there are validated 
treatments for comorbid alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in 
hearing populations, there are no evidence-based treatments to treat any behavioral health 
condition with Deaf clients. Current treatments fail to meet Deaf clients’ unique linguistic and 
cultural needs. Deaf people’s median English reading level falls at the fourth grade, and many 
have low health literacy due to reduced incidental learning (e.g., inability to communicate with 
hearing parents, overhear family conversations, or understand spoken health information on 
TV/radio/public service announcements). Written treatment materials, therefore, require plain 
text revisions, ASL translations, or ASL narrative storytelling. Equally important are materials 
that incorporate Deaf values and social norms, increasing clinicians’ cultural competence and 
enhancing client engagement.  
 
To address these barriers, the PI conducted a KL2 pilot study to develop a prototype of Signs of 
Safety: a Deaf-accessible toolkit to be used alongside a widely-disseminated protocol for 
addiction/PTSD – Seeking Safety. Seeking Safety has demonstrated efficacy for reduction of 
AUD and PTSD symptoms in hearing populations. Among available evidence-based protocols, 
Seeking Safety is the optimal choice to adapt for Deaf clients – its focus on simple coping skills 
that simultaneously target AUD and PTSD (or either alone) is an ideal match for Deaf people’s 
language and learning deficits, which prohibit use of verbal problem-solving and cognitive 
processing strategies that other psychotherapies require. Yet, Seeking Safety’s client materials 
rely on written English and are not well understood by Deaf clients. As such, the Signs of Safety 
toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; 
ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-
signing clinicians working with ASL interpreters.  
 
Data from the PI’s KL2 Signs of Safety single-arm pilot study (n = 13) show significant 
reductions in alcohol use frequency and PTSD severity from baseline to immediate post-
treatment follow-up. Participants also reported high levels of satisfaction with the model, and 
provided detailed feedback about how to further improve Signs of Safety for a professional-
quality, second iteration (See Section 5. d. for more detailed results). The proposed study builds 
upon the PI’s KL2 work by generating a final, professional iteration of Signs of Safety to be used 
in future efficacy work. Based on KL2 pilot results, we will create a second iteration of the Signs 
of Safety toolkit, including re-filming ASL teaching stories, re-designing visual handouts, and 

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revising the therapist companion guide. We will then develop a training program for Signs of 
Safety and certify four study clinicians.  
 
We propose to conduct a two-arm pilot RCT of Signs of Safety. We aim to enroll 60 Deaf 
adults with past-month PTSD and past-month alcohol consumption to participate in 12 weekly 
individual treatment sessions. The pilot RCT will compare the 12-session protocol of Seeking 
Safety + Signs of Safety toolkit with an assessment-only waitlist control. Across conditions, 
assessment will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-
month follow-up/week 16. We will analyze key aspects of feasibility for both study arms (e.g., 
recruitment, retention, assessment process). Primary clinical outcomes at immediate post-
treatment and one-month follow-up are past 30-day alcohol use frequency/quantity and past 30-
day PTSD severity. Exploratory analyses will be conducted to examine potential moderators and 
mediators of change (e.g., motivation for treatment, provider cultural competency, coping skills, 
self-compassion, understanding of health information) leading to positive outcome. Results from 
this study will produce feasibility and preliminary efficacy data to support for a full-scale RCT to 
evaluate Signs of Safety, and a community-engaged model for conducting RCTs with Deaf 
participants. 
 
5. BACKGROUND* 
 
a. Deaf people experience triple the rate of lifetime problem drinking and double the rate of 
trauma exposure compared to the general population. The U.S. Deaf community – a group of 
500,000+ Americans who communicate using American Sign Language (ASL) – reports nearly 
three times the rate of lifetime problem drinking compared to the general population (33.0% vs. 
12.3%). An estimated 15% of Deaf Americans meet criteria for current alcohol use disorder 
(AUD). High rates of comorbid trauma complicate the treatment course for this unique clinical 
population, with Deaf people twice as likely to experience lifetime and past-year trauma 
exposure compared to individuals in the general population. While 25% of hearing women report 
lifetime prevalence of domestic violence, this figure surpasses 50% among Deaf women. This 
disparity has also been documented for rates of sexual assault, sexual harassment, and child 
abuse.  
 
Risk for AUD is heightened among trauma survivors compared to individuals without history of 
trauma – 6.5 times more likely among hearing men with PTSD and 4.5 times more likely among 
hearing women with PTSD than those without PTSD. Among Deaf people in AUD treatment, 
74% report lifetime and 44% report past-year physical, emotional, or sexual abuse, as compared 
to 60% and 34% of hearing peers in treatment, respectively. Comorbid AUD/PTSD complicates 
treatment and affects multiple domains of functioning. Hearing individuals with this comorbidity 
have greater physical and social impairment, higher rates of mood, anxiety, and personality 
disorders, and increased trauma-related craving (i.e., craving substances in response to PTSD 
symptoms) compared to those with AUD alone. Deaf people show even greater impairment than 
hearing peers, with poorer outcomes in socialization, employment, and physical health. Although 
AUD treatment in the general population doesn’t typically focus on PTSD, given that most Deaf 
clients who enter behavioral health treatment have trauma histories and 74% of Deaf people in 
AUD treatment have experienced abuse, it is logical to integrate trauma treatment into 
interventions designed for this population. 

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b. Although there are validated treatments for comorbid AUD/PTSD in hearing 
populations, there are no evidence-based treatments for any behavioral health condition 
for use with Deaf people. Currently available treatments fail to meet the unique linguistic and 
cultural needs of Deaf clients. Deaf people’s median reading level falls at the fourth grade, and 
many present with low health literacy due to reduced incidental learning throughout the lifespan 
(e.g., inability to communicate with hearing parents, understand spoken health information on 
TV/radio/PSAs). Written English treatment materials, therefore, require plain text revisions or 
ASL translations. Additionally, treatments commonly used for PTSD (e.g., Cognitive Processing 
Therapy, Prolonged Exposure, EMDR) rely on the client’s ability to formulate a trauma narrative 
– either for restructuring maladaptive cognitions or exposing oneself to triggering content. Due 
to lack of early language exposure and poor educational experiences, many Deaf adults enter 
treatment unable to formulate a narrative or report a coherent timeline of events. This prohibits 
use of verbal problem-solving and cognitive processing strategies that these evidence-based 
therapies require.  
 
Equally important are treatment materials that increase clinician cultural competence and 
enhance client engagement by being inclusive of Deaf values and social norms, acknowledging 
Deaf people’s history of oppression, and embracing Deaf people’s identity as a cultural – not 
disability – group.  Whereas clinicians often adopt a medical view of “hearing impairment,” most 
Deaf clients do not view themselves as “impaired,” but as members of a rich community with 
shared experience, history, and culture.  
 
c. To address these access barriers, during her KL2, the PI assembled a multidisciplinary 
Deaf and hearing research team to create “Signs of Safety,” a culturally and linguistically 
Deaf-accessible toolkit to be used alongside an existing, present-focused, first-stage 
manualized treatment for trauma and addiction – Seeking Safety. Although there is 
preliminary-to-promising evidence for a number of other manualized treatments for comorbid 
AUD/PTSD – Prolonged Exposure (PE), modified Prolonged Exposure (mPE), Eye Movement 
Desensitization and Reprocessing (EMDR), Cognitive Processing Therapy (CPT), integrated 
Cognitive Behavioral Therapy (ICBT), Concurrent Treatment of PTSD and Substance Use 
Disorders Using Prolonged Exposure (COPE) – these treatments rely on the client’s ability to 
formulate a trauma narrative, either for restructuring maladaptive cognitions or exposing oneself 
to triggering content. Due to lack of early language exposure, poor educational experiences, and 
resulting long-term language dysfluency, most Deaf adults enter treatment unable to construct a 
narrative or a coherent timeline of events. Verbal problem-solving and cognitive processing 
strategies required by most evidence-based AUD/PTSD therapies are, therefore, contraindicated 
in the treatment of Deaf clients.  
 
Given this contraindication, our team selected Seeking Safety as the base intervention due to its 
present-focus (i.e., no need to retell the trauma narrative) and reliance on simple coping skills 
that simultaneously target AUD and PTSD. Session content engages clients in themes relevant to 
addiction and PTSD, and to help them learn a specific skill to target symptoms of both disorders 
(e.g., “Coping with Triggers,” “Asking for Help”). It has been used successfully with diverse 
populations, translated into 12 foreign languages, and aligns with many recommended practices 

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for Deaf-friendly treatment (i.e., skill-building and psychoeducation, structured sessions, case 
management, present focus, strength-based work).  
 
Recent studies of Seeking Safety with comorbid AUD/PTSD outcomes are as follows: 
 
(1) Najavits et al. (2018) conducted an RCT with 52 male and female veterans comparing 17 
sessions of Seeking Safety with Creating Change. There were no significant differences 
between conditions. Both led to reductions in alcohol use and PTSD symptoms from 
baseline to end-of-treatment. PTSD gains were sustained and reductions in alcohol use 
continued to improve through three-month follow-up. 
 
(2) A 2016 pilot study evaluating Seeking Safety among 24 outpatient military members 
reported significant reduction in alcohol and drug use as measured by the Brief Addiction 
Monitor, with both alcohol and drug abstinence among all participants at end of 
treatment.  
 
(3) Hien et al. (2015) conducted an RCT comparing 12-session Seeking Safety plus sertraline 
versus Seeking Safety plus placebo among 69 men and women with AUD/PTSD. Both 
conditions evidenced clinically significant improvement in AUD and PTSD at end of 
treatment and at 12-month follow-up.  
 
(4) Kaiser et al. (2015) evaluated 12-session Seeking Safety in a sample of 53 German female 
outpatients with current substance use disorder and PTSD. Among minimum completers 
(i.e., 6+ sessions attended, PTSD symptoms improved significantly by end-of-treatment, 
with gains sustained through three-month follow-up. Alcohol use improved significantly 
only at follow-up. 
 
(5) Myers at al. (2015) conducted an RCT comparing 25 sessions of Seeking Safety with 
Facilitated Twelve-Step among female survivors of intimate partner violence. There were 
no differences in PTSD or AUD outcomes between conditions at post-treatment; 
however, given the small sample size entered into the analyses (Seeking Safety n = 14; 
12-Step n = 4), the study may have been underpowered. 
 
(6) Zlotnick et al. (2009) conducted a pilot RCT comparing Seeking Safety plus TAU to 
TAU-only among 49 incarcerated women with substance use disorder and PTSD. Neither 
condition was superior; both showed improvements in PTSD and substance use from 
intake to 3- and 6-month follow-up. Only women in TAU showed a significant decrease 
in alcohol use from intake to 3-month follow-up.  
 
(7) Hien et al. (2009) compared 12 sessions of Seeking Safety versus Women’s Health 
Education among 353 women with substance use disorder and PTSD as part of NIDA’s 
Clinical Trials Network (CTN). Results indicated large, clinically significant reductions 
in PTSD, but no differences between conditions. No improvement in substance use was 
found for either condition, likely due to a 46% abstinence rate at baseline and resulting 
floor effects. Specific to alcohol outcomes, a secondary analysis by Hien et al. (2010) 
reported that participants with baseline alcohol misuse enrolled in Seeking Safety showed 

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significantly greater reductions in PTSD at follow-up compared to those enrolled in 
health education.   
 
Despite mixed results among general population samples, the PI’s secondary analysis of NIDA 
CTN data found that, among women with physical disabilities, those treated with Seeking Safety 
experienced sustained reductions in PTSD symptoms while women in Women’s Health 
Education experienced full PTSD recurrence by 12-month follow-up. Changes in AUD over 
time could not be investigated, as the majority of the sample reported no baseline alcohol use. 
Despite this limitation, our analysis provided preliminary support that Seeking Safety might be an 
engaging and effective approach for individuals with disabilities, including Deaf individuals.  
 
d. Results from the PI’s KL2 single-arm pilot study show reductions in alcohol use 
frequency and PTSD severity from baseline to immediate post-treatment. Participants in the 
Signs of Safety single-arm pilot study (n = 13) reported high levels of satisfaction, supported by a 
23% attrition rate (3/13), lower than the average rate of 27% observed in addiction longitudinal 
studies. Reported reasons for attrition were lack of interest, readiness, or motivation to engage in 
the study protocol. Our attrition rate is especially noteworthy given that participants retained in 
treatment completed the full 25-session treatment protocol and end-of-treatment assessment. 8 
participants (61.5%) became abstinent or evidenced clinically meaningful reduction in percent 
days of alcohol use by the end of treatment. Participants also exhibited a 10-point mean 
reduction on the PTSD Checklist for DSM-5 (PCL-5), a clinically meaningful improvement on 
this measure.  
  
Pilot participants also provided vital feedback about how to produce an improved version of 
Signs of Safety. Suggestions included, but are not limited to: revised ASL translations of certain 
recovery concepts; specific plot changes in the ASL Teaching Stories to better reflect the process 
of recovery from AUD and PTSD; changing gender of the therapist character; and inclusion of 
greater diversity with respect to age and sexual orientation of ASL Teaching Story characters. 
Our proposed aims will, therefore, build upon the PI’s KL2 work by generating a final, 
professional iteration of Signs of Safety, training study clinicians, and moving this behavioral 
therapies research program to a two-arm feasibility and pilot testing.  
 
6. INCLUSION AND EXCLUSION CRITERIA* 
We aim to enroll 60 Deaf adults from New England using rolling recruitment across two years. 
Based on the KL2 pilot results, we predict that 45 of 60 participants (conservative retention rate 
of 75%) will complete end-of-treatment assessment.  
 
Inclusion criteria: 
• Self-identification as a Deaf ASL user 
• Age 18 or older 
• Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification 
Test 
• Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time 
period; “subthreshold” = endorsement of at least two B-E criteria at a severity of 
“moderate” or higher) 

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• Ability to attend weekly study sessions at one of four study locations (Eastern, Central, or 
Western MA) 
• Ability to access a videophone (the standard telecommunication device for the Deaf 
community) 
 
Exclusion criteria: 
• Participation in concurrent therapies (Note: Participants in both study conditions will be 
asked to refrain from concurrent formal psychotherapy; however, aligning with the 
Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be 
tracked as a potential outcome mediator). 
• Members of the following special populations: Adults unable to consent; Individuals 
younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include 
pregnant women as participants; however, we will not assess participants’ pregnancy 
status.)  
 
Exclusion criteria are intentionally minimal to recruit a diverse sample. Other behavioral health 
comorbidities (e.g., mood/anxiety disorders, substance use disorders other than AUD) will not be 
excluded, given high rates of comorbidity.  
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A 
 
9. STUDY TIMELINES* 
The total duration of the study will be 3 years (Table 1). Primary analyses will be completed by 
end of year 3. We anticipate that it will take 2 years of rolling recruitment to enroll all study 
participants (Table 2). Participation in the study will last at most 6 months.  
 
Table 1: Study Timeline 
YEAR: 
1 
2 
3 
QUARTER: 1 2 
3 4 
1 2 
3 4 1 
2 3 4 
Create final, professional iteration of Signs of Safety toolkit 
 
 
 
 
 
 
 
 
 
 
 
 
Develop clinician training and supervision program 
 
 
 
 
 
 
 
 
 
 
 
 
Train and certify study clinicians (+back-up clinician)  
 
 
 
 
 
 
 
 
 
 
 
 
Pilot RCT preparation, IRB approval, registration on ClinicalTrials.gov 
 
 
 
 
 
 
 
 
 
 
 
 
Pilot RCT: Rolling recruitment, enrollment, and randomization (n=60) 
 
 
 
 
 
 
 
 
 
 
 
 
Ongoing fidelity rating, data entry, and analyses for safety monitoring 
 
 
 
 
 
 
 
 
 
 
 
 
Final data analyses, report/paper writing, and R01 preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2: Study Recruitment Flow Chart  
(“E” = # of participants actively enrolled in study protocol; “
” = # of participants completed study protocol) 
YEAR 1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Study start-up 
Rolling recruitment and study period 
(recruitment rate ≈ 1 per month x 3 sites) 
•     Create professional iteration of Signs of Safety 
• 
Train and certify study clinicians 
E = 3 
= 0 
E = 6 
= 0 
E = 9 
= 0 
E = 12 
= 0 
E = 15 
= 0 

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YEAR 2 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Rolling recruitment and study period  
(recruitment rate ≈ 3 per month; length of study period ≈ maximum 6 months per participant) 
E = 18 
= 0 
E = 18 
= 3 
E = 18 
= 6 
E = 18  
= 9 
E = 18 
= 12 
E = 18 
= 15 
E = 18 
= 18 
E = 18 
= 21 
E = 18 
= 24 
E = 18 
= 27 
E = 18 
= 30 
E = 18 
= 33 
YEAR 3 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
 
No recruitment; study period only  
(length of study period ≈ maximum 6 mo./participant) 
Study wrap-up 
E = 18 
= 
36 
E = 18 
= 39 
E = 18 
= 
42 
E = 15 
= 
45 
E = 12 
= 
48 
E = 9 
= 51 
E = 6 
= 54 
E = 3 
= 57 
E = 0 
= 60 
• 
Final follow-up 
• 
Data analyses 
• 
Optional exit 
interview 
 
10. STUDY ENDPOINTS* 
The primary and secondary clinical outcome measures are outlined in Table 3 below. 
 
 
Identification of serious psychiatric problem. If at any time a participant is identified as 
having a serious psychiatric problem that requires a higher level of care than our study can 
provide, this concern will be immediately reported to the PI, who will provide referral and 
bridging to appropriate treatment options for stabilization. Once stabilized, the participant will 
have the option to return to our study. 
 
Clinical emergencies. Study clinicians and Study Assessor will contact 911 in the event of a 
dangerous situation (or the PI for less urgent clinical crises), and will complete adverse events 
Table 3: Clinical Outcome Measures 
Variable 
Measure 
(primary outcome measures noted in bold font) 
Time Point 
Screen Baseline/ 
Pre-TX Week 4 Week 8 Week12/ 
Post-TX 
1-month 
Follow-up 
Alcohol Use 
and Craving 
AUD Identification Test (AUDIT)  
X 
 
 
 
 
 
Alcohol Timeline Followback 
 
X 
X 
X 
X 
X 
Comprehensive Effects of Alcohol Scale - Brief 
 
X 
X 
X 
X 
X 
Penn Alcohol Craving Scale (PACS)  
 
X 
X 
X 
X 
X 
PTSD 
PTSD Checklist for DSM-5 (PCL-5)  
X 
X 
X 
X 
X 
X 
Trauma Symptom Checklist – 40 (TSC-40)  
 
X 
 
 
X 
X 
Behavioral 
Health 
Behavior and Symptom Identification Scale  
(BASIS-24)  
 
X 
 
 
X 
X 
Mediators 
and 
Moderators 
of Change 
Coping Self-Efficacy Scale 
 
X 
X 
X 
X 
X 
Self-Compassion Scale – Short Form 
 
X 
X 
X 
X 
X 
Ask, Understand, Remember Assessment (AURA)  
 
X 
X 
X 
X 
X 
Stages of Change Readiness and Treatment 
Eagerness Scale (SOCRATES 8A)  
 
X 
 
 
X 
X 
Healthcare Provider Cultural Competency 
 
X 
 
 
X 
X 

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reports. The PI will intervene if at any time a participant’s distress cannot be contained or in 
cases where one appears truly unsafe (suicidal intent, threatening harm, or other unsafe 
behavior). Although it is anticipated that this reaction is highly unlikely, should it occur, the PI 
will provide debriefing and, if needed, will implement any actions required by Massachusetts 
law. 
 
Deterioration. After each assessment time point, the PI will review data to ascertain if any 
particular participants are reporting significant clinical deterioration (i.e., “clinically meaningful” 
increase of 10+ points on the PTSD Checklist for DSM-5, increase in AUD category of severity 
based on DSM-5 criteria). Should a participant be identified as experiencing significantly 
worsening distress over the course of the study, the PI will determine appropriate course of 
action (e.g., withdrawal from study and referral to outside treatment). Again, once stabilized, the 
participant would have the option to return to our study. 
 
11. PROCEDURES INVOLVED* 
 
The procedures are informed by data generated during the PI’s KL2 single-arm pilot study. We 
will create a professional-quality iteration of the Signs of Safety toolkit (see attached scripts), 
develop a clinician training program, and certify four study clinicians. Procedures for the 
proposed two-arm pilot RCT are as follows: 
 
Recruitment. Across two years of rolling recruitment, 60 Deaf adults with past-month PTSD 
and high-risk alcohol consumption, drinking behaviors, and alcohol-related problems will be 
enrolled in a two-arm pilot RCT. Recruitment materials will direct individuals to contact the 
research team via videophone. See Section 24: Local Recruitment Methods for more detail. 
 
Informed Consent. Interested individuals will be offered a one-hour videophone appointment 
during which the PI will conduct informed consent procedures and, for consenting individuals, 
eligibility screening. Prior to the scheduled video call, the PI will provide each participant with 
an electronic copy of the IRB-approved, written English informed consent form (e-Consent) via 
Research Electronic Data Capture (REDCap). See Section 30: Consent Process and Section 31: 
Process to Document Consent in Writing for additional detail.  
 
Screening. Individuals who consent to participate will then be immediately screened by the PI to 
determine eligibility. The PI will conduct a structured clinical interview via videophone to 
determine whether each individual satisfies inclusion and exclusion criteria. Past-month alcohol 
consumption will be assessed with the Alcohol Use Disorder Identification Test. “Subthreshold 
or full PTSD” will be assessed with the PTSD Checklist for DSM-5 (PCL-5).  
 
Study Conditions. After enrollment, the Study Assessor will conduct the baseline assessment 
via videophone. Participants will then be randomly assigned to one of two conditions: (1) 
Seeking Safety + Signs of Safety toolkit, or (2) assessment-only waitlist control. Randomization 
will occur within each study site and stratified by gender. The Biostatistician will generate a 
computerized random number series and place numbers in individual sealed opaque envelopes. 
The RC will open an envelope to randomly assign a treatment condition to the participant. Both 
the PI and Study Assessor will be blind to study condition. (Note: the Study Assessor will remain 
blind to study condition until the end of the post-treatment assessment, at which point she will 

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administer a client satisfaction measure that will unblind the Co-I to which subjects are in the 
waitlist control group.) 
 
Intervention: Participants randomized to receive the intervention will be provided weekly 
individual treatment with one of four ASL-fluent study clinicians, based on preferred location 
and transportation needs. Each participant in this condition will receive 12 one-hour sessions of 
treatment. The maximum length of treatment will be capped at six months and the total number 
of completed sessions will be tracked as a measure of participant adherence. Therapists will treat 
an approximately equal percentage of participants, in order to minimize confounding of therapist 
effect and study site on treatment outcome. 
 
Treatment sessions will be provided in each study clinician’s private practice office, in direct 
response to findings from the PI’s NIDCD R21, which revealed Deaf people’s communal fear of 
academic research settings due to a long history of mistreatment by doctors and biomedical 
researchers (e.g., eugenics) (Anderson, Wolf Craig, & Ziedonis, 2016; Anderson et al., 2018; 
Anderson, Wolf Craig, & Ziedonis, 2017; McKee, Schlehofer, & Thew, 2013; Lane, 2005). As 
such, study therapists must be independently licensed in MA and will take on professional 
liability for the cases that they see. Study therapists will be compensated $80 a session – a rate 
that is comparable to the average insurance reimbursement for individual therapy sessions with 
Deaf clients. Proof of sufficient liability insurance will be obtained from each study therapist 
prior to beginning the RCT.  
 
Waitlist Control: Following the final assessment at 16 weeks, waitlist control participants will be 
offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety protocol. This 
16 week waiting period is equivalent to the current waitlist to receive psychotherapy services 
through the PI’s outpatient clinic. Participants who are randomized to the waitlist, but express 
immediate need for services during the waitlist period will be provided referral to non-study 
treatment options (i.e., supportive psychotherapy provided either directly in ASL or with an ASL 
interpreter) and subsequently coded as a non-retained waitlist participant. 
 
Assessments. Using measures validated in the general population, we will assess clinical 
outcomes and mechanisms of change at baseline, two within-treatment time points (after session 
4 and 8), immediate post-treatment (within one week after session 12), and one-month follow-up. 
The Study Assessor, blind to study condition, will administer assessments as structured ASL 
interviews via videophone. (Note: the Study Assessor will remain blind to study condition until 
the end of the post-treatment assessment, at which point she will administer a client satisfaction 
measure that will unblind the Co-I to which subjects are in the waitlist control group.) Any 
Likert-scale-type questionnaires that are administered during the study interview will be 
presented directly in American Sign Language; the interviewer will also display a visual aid of 
the response options to assist participants in keeping track of changing Likert scales between 
various measures. 
 
Compared to in-person assessments, our proposed method of remote videophone assessment is 
more responsive to Deaf people’s transportation barriers, financial barriers, and technology 
preferences. This videophone method was used successfully in the Signs of Safety one-arm pilot 
study, as well as other previous studies with Deaf individuals. Participants will be compensated 

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$25 at each assessment time point (1 hour for baseline, 30 minutes for follow-up) via a Visa gift 
card sent to the mailing address of their choice. Participants not retained in treatment will be 
contacted for follow-up assessments at each scheduled time point for intent-to-treat analyses and 
examination of potential biases due to non-adherence.  
 
In the control condition, assessment will occur at baseline, week 4, week 8, week 12 (to 
approximate immediate post-treatment), and week 16 (to approximate one-month follow-up). 
Such repeated assessment in the control arm will allow us to quantify and control for 
participants’ natural change over time and assessment reactivity. 
 
Feasibility measures: We will collect data on recruitment, retention, and other key aspects of 
feasibility (Table 3). We will augment client satisfaction measures with questions specific to 
Signs of Safety. All intervention sessions will be videotaped, with 25% (3 sessions per 
participant) rated for fidelity on an ongoing basis by the Fidelity Consultant To quickly correct 
fidelity concerns, capture fidelity throughout the treatment process, and evaluate impact of site 
differences on study findings, one tape will be randomly selected from sessions 1 - 4; one from 5 
- 8; and one from 9 - 12. Sessions will be rated with the Seeking Safety Adherence Scale plus the 
Signs of Safety Fidelity Scale.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Measures of clinical outcome, moderators, and mediators: Using measures validated in the 
general population, we will assess clinical outcomes and mechanisms of change at baseline, two 
within-treatment time points (week 4 and 8), immediate post-treatment (within one week after 
session 12), and one-month follow-up. We will report internal consistency of all measures in our 
study sample when administered in ASL format, compared with the general population. 
Measures of clinical outcome are: the Alcohol Timeline Followback, which assesses daily 
drinking frequency and quantity for a selected range of 30 to 360 days (we will use 30 days); the 
Comprehensive Effects of Alcohol Scale – Brief Version, a 15-item measure of positive/negative 
expectancies and valuations of various possible consequences of drinking; the Penn Alcohol 
Craving Scale (PACS), a 5-item instrument assesses study participants’ self-report craving levels 
for alcohol; the PTSD Checklist for DSM-5 (PCL-5), a 20-item measure of DSM-5 PTSD 
symptoms that is reliably used to monitor symptom change; the Trauma Symptom Checklist – 40 
(TSC-40), a 40-item measure of the long-term effects of complex trauma; and the Behavior and 
Table 3: Feasibility Measures 
Component 
Feasibility Quantification 
Client  
Satisfaction 
- Seeking Safety End of Session Questionnaire* 
- Seeking Safety End of Treatment Questionnaire* 
- Client Satisfaction Questionnaire (post-TX)  
Treatment  
Fidelity 
- Rates of therapist integrity to the experimental 
condition 
Participant  
Adherence 
- Treatment receipt (i.e., number of sessions 
completed, comprehension of session content) 
- Rates of participants’ treatment enactment (i.e., 
completing “homework” between sessions) 
Assessment  
Process 
- Proportion of planned ratings completed 
- Duration of assessment call 
- Psychometrics of clinical outcome measures 
*Measures that include open-ended items for qualitative data analysis. 

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Symptom Identification Scale – 24 (BASIS-24), a 24-item measure of psychiatric and substance-
related symptoms and level of functioning.  
 
Given the limited scope of the proposed study and the resulting proposed sample size, we will 
collect only preliminary data on mechanisms of change and conduct exploratory analyses of 
these potential mechanisms. We identified potential mechanisms from published studies of 
Seeking Safety, the alcohol treatment literature, and Deaf mental health literature. Potential 
mediators are participants’ reported ability to use coping skills, practice self-compassion, and 
understand health information. Potential moderators are motivation for treatment and participant-
reported provider cultural competency. These constructs will be measured by the Coping Self-
Efficacy Scale, a 26-item measure of perceived ability to cope with past-month challenges; the 
Self-Compassion Scale – Short Form, a 12-item measure of self-compassion in instances of 
perceived failure, inadequacy, or suffering; the Ask, Understand, Remember Assessment (AURA), 
a 4-item measure of one’s ability to obtain, understand, and remember health information 
communicated by a provider; the Stages of Change Readiness and Treatment Eagerness Scale 
(SOCRATES 8A), a 19-item measure assessing readiness for change among individuals with 
AUD; and Patient-Reported Healthcare Provider Cultural Competency, a 9-item measure rating 
a provider’s ability to interact with patients from one’s cultural group.  
 
Exit Interview (optional). After a participant’s participation in the study is complete, they will 
be given the option to participate in a videophone exit interview. This interview will be 
conducted by an ASL-fluent interviewer. The participants will be asked their opinions about how 
the current study was designed and if any improvements can be made for future research studies 
(see Signs of Safety Exit Interview questions attached). For example, participants will be asked 
questions about their experience of participating in the research study, including logistics, 
accessibility, communication, and technology. The exit interview will take approximately 60 
minutes. Participants will receive an additional $50 Visa gift card if they choose to participant in 
the exit interview. 
 
12. DATA AND SPECIMEN BANKING* 
N/A 
 
13. Data Analysis and Management* 
 
Data will be entered into Research Electronic Data Capture (REDCap), a secure web-based data 
capture application that provides real-time data entry validation (e.g., data types, range checks). 
UMass Quantitative Methods Core personnel will customize the database to track recruitment, 
intervention delivery, and outcome assessments. Data will be exported to SAS and ATLAS.ti for 
analysis. 
 
Analyses will be conducted as intent-to-treat, with all randomized participants included in the 
analysis regardless of treatment adherence or missing data in any time points. We will use the 
mixed procedure (PROC MIXED) in SAS to analyze the longitudinal data by fitting the models 
described below – a procedure that allows for data that are missing at random by including all 
available data from each participant in the analysis. In the event that a participant has no 

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available outcome data, we will examine their sociodemographic characteristics to compare with 
those participants who do have available outcome data.  
 
Analytic plan for feasibility. For quantitative feasibility outcomes, we will calculate descriptive 
statistics for the overall sample and separated by treatment arm: mean number of participants 
screened and enrolled per week; rate of retention; clinician treatment fidelity (rates of integrity, 
rates of differentiation); participant adherence (number of sessions completed, rates of between-
session homework completion); and assessment process (proportion of assessments completed, 
mean duration of assessment calls). We will compare retention, fidelity, and adherence between 
the two treatment conditions using chi-square and t-tests.   
 
Precision of rate estimation: Based on pilot results, we anticipate at least 45 of the 60 enrolled 
participants will be retained through immediate post-treatment. See Section 25. Local Number of 
Subjects for more information on the estimated post-attrition sample size and retention rate.  
 
For qualitative feasibility outcomes, open-ended responses to the End of Session and End of 
Treatment Questionnaires will be analyzed in ATLAS.ti for themes regarding satisfaction with 
each study arm (e.g., What comments or suggestions do you have about today’s session?, How 
could this treatment be more helpful to you?). We will use an iterative, grounded theory 
approach employing two major techniques: (1) content analysis, where the number of similar 
responses will be tallied and described; and, (2) a summary of the answers to questions outlined 
by Casey (e.g., What ideas will be especially useful for the intervention?). 
 
Analytic plan for preliminary clinical outcomes. We will compare treatment arms using two 
primary clinical outcomes at immediate post-treatment and one-month follow-up: (1) past 30-day 
alcohol use frequency/quantity (from Alcohol Timeline Followback); and, (2) past 30-day PTSD 
severity (from PCL-5). For alcohol use, outcome variables are: % drinking days per week (i.e., 
days with 1+ drink); % binge drinking days per week (i.e., days with 5+ drinks for men, 4+ for 
women); and mean number of drinks per week. These variables will be calculated from daily 
data collected with the Alcohol Timeline Followback for 30 days (4 weeks) prior to the last drink 
before baseline assessment, throughout the 12-week intervention or waitlist period, and 
throughout the one-month follow up period. Such a weekly measure will allow for estimation of 
changes per weekly intervention session in the experimental condition as compared to waitlist 
control.  
 
Our initial unadjusted group comparisons at immediate post-treatment/week 12 and at the end of 
the one-month follow-up period/week 16 will use a standard t-test (or Wilcoxon non-parametric 
test, depending on the outcome distribution). Below, we describe models for analyzing adjusted 
group differences and for analyzing the longitudinal data. We acknowledge that, with the small 
sample size of this feasibility study, the following models may be optimistic in terms of their 
capability to reliably estimate and to test interactions. However, they will provide insight into 
possible effect sizes for planning the larger clinical trial. 
 
We will first compare differences in weekly drinking between the two study conditions at pre-, 
during, and post- intervention periods using mixed effects models (Model 1): 
 

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Y = b0 + b1*int_pr + b2*fu_pr + b3*e + b4*int_pr*e+ b5*fu_pr*e + other predictors (p_chars, 
c_chars, clinician, study site, etc.) + random effects 
 
Where: Y = alcohol use dependent variable; int_pr = 1 for intervention period, = 0 otherwise; 
fu_pr = 1 for follow-up period, = 0 otherwise; e = 1 for experimental arm, = 0 for control arm; 
p_chars are participant characteristics (e.g, age, gender); c_chars are clinician characteristics 
(e.g, age, gender); clinician indicators will capture differences in clinician approaches; and, study 
site indicators will capture differences in location of intervention delivery. Random effects (i.e., 
participants) will account for unmeasured participant characteristics. 
 
We will examine the linear time trend of intervention effects using interrupted time series 
analysis (Model 2): 
 
Y = a0 + a1*wk + a2*int_pr + a3*wk_aft + a4*e + a5*wk*e + a6*int_pr*e + a7*wk_aft*e + 
other predictors (p_chars, c_chars, clinician, study site, etc.) + random effects 
 
Where: Y = alcohol use dependent variable; wk = week number starting with 1 for the first week 
of data collection; int_pr = 1 for intervention period, = 0 otherwise;  wk_aft = # of week after the 
intervention starts; e = 1 for experimental arm, = 0 for control arm; and other predictors and 
random effects as defined in Model 1. Both models will include multilevel clustering to account 
for repeated measures from the same participant, as well as correlation among participants 
receiving intervention in the same study site.  
 
For PTSD symptoms, the primary outcome is past 30-day total symptom severity on the PCL-5. 
We will compare study conditions on the PCL-5 total symptom severity score at each time point 
using a mixed effects model (Model 3). Fixed effects are: study condition (experimental vs. 
control), time point (four indicator variables with baseline as the reference group), and 
interaction of study condition and time point. Similar to Models 1 and 2, we will adjust for 
participant and clinician characteristics; within-clinician, within-site, and repeated measures 
correlation; and random effects (i.e., unmeasured participant characteristics).  
 
Sample size and power calculation: Our proposed sample size is based on pilot results and the 
limited scope of the proposed pilot RCT. A clinically significant effect should be used for 
planning a future full-scale RCT. For example, a clinically significant change score for the PCL-
5 is 10 points, equal to an effect size of 0.47 using a standard deviation of 21.2. Our projected 
sample size of 22 completers per study arm will have 80% power to detect a large effect size 
(0.80) comparing two means using a two independent sample t-test for the unadjusted group 
comparisons. To detect a smaller effect size (e.g., clinically significant effect size of 0.47), a 
larger sample size would be needed, but is not feasible due to the scope of the proposed pilot 
RCT. We used the unadjusted t-test for the power calculations due to the largely unknown 
assumptions required to calculate the power for a mixed effects model; however, the mixed 
effects models will have more power than the unadjusted t-test due to the partitioning of the 
variance among the various components.  
 
Analytic plan for potential mechanisms of change. We will examine potential moderators and 
mediators of intervention effects. We will compare the two treatment arms on these variables at 

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each time point using mixed effects regression models similar to Model 3, described above. To 
test for a significant effect of moderators/mediators, we will follow the approach of Kraemer et 
al., as described below, and will classify baseline factors (e.g., stable patient characteristics, 
motivation for treatment, perceived provider cultural competency) as moderators and factors that 
may be related to the intervention as mediators, such as coping skills, self-compassion, and 
understanding of health information. 
 
In the mixed effects models, we will include the individual mediator (or moderator) as well as 
the treatment*mediator (or moderator) interaction term. We will maintain the hierarchy of the 
interaction and main effect, so that the main effect will stay in the model regardless of its 
significance if the interaction shows a significant effect. The interpretation of the 
treatment*mediator interaction is that the treatment has a differential effect on the outcome 
through the mediator; for example, participants who understood more of the health information 
presented during the intervention may have a different response to the treatment than those who 
understood less. In the case of moderators, the interaction would indicate a differential treatment 
effect in various subgroups of patients. The interpretation of the model will vary depending on 
whether the main effects are significant (and which ones) and whether the interaction is 
significant (with or without significant main effects). Because of the sample size for this pilot 
RCT, we cannot power the study to identify significant interactions (except for large effects), but 
can use the interaction effect size to better plan for future efforts. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
The PI, Co-I/AUD Research Consultant, and Biostatistician will monitor individual data over the 
course of the study to identify any participants who may need additional intervention. Frequency 
and quantity of weekly alcohol and drug use will be collected at the beginning of each session 
during the structured check-in process. PTSD symptoms will be collected at baseline, after 
session 4, after session 8, immediate post-treatment, and one-month post-treatment follow-up. 
Suicidal thoughts, plans, or intent will be assessed at the beginning of each session during the 
structured check-in if the participant reports feelings of depression, as well as at baseline, after 
session 4, after session 8, immediate post-treatment, and one-month post-treatment follow-up if 
the participant endorses suicidal ideation during clinical outcome assessments. Additionally, 
there is a check-out process at the end of each session (part of the manualized Seeking 
Safety/Signs of Safety protocol) that asks participants what they got out of the session and if any 
problems arose for them, and participants complete an end-of-session satisfaction questionnaire 
that assesses any points of dissatisfaction about the session.  
 
After each assessment time point, the PI, Co-I/AUD Research Consultant, and Biostatistician 
will review data to ascertain if any particular participants are reporting significant clinical 
deterioration (i.e., “clinically meaningful” increase of 10+ points on the PTSD Checklist for 
DSM-5, increase in AUD category of severity based on DSM-5 criteria). Should a participant be 
identified as experiencing significantly worsening distress over the course of the study, the PI, 
Co-I/AUD Research Consultant, and Biostatistician will determine appropriate course of action 
(e.g., withdrawal from study and referral to outside treatment). Once stabilized, the participant 
would have the option to return to our study. 
 
 

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If at any time a participant is identified by study clinicians or Study Assessor as having a serious 
psychiatric or substance use problem that requires a higher level of care than our study can 
provide, this concern will be immediately reported to the PI, who will provide referral and 
bridging to appropriate treatment options for stabilization. Again, once stabilized, the participant 
will have the option to return to our study.  
 
 
Should a participant arrive at a study session under the influence of drugs or alcohol, the study 
clinician will be trained to discontinue the session, reschedule the visit for a later date, and work 
with the participant to arrange safe transport home (e.g., being picked up by family member or 
friend, taking a taxi, etc.).  
 
Should a participant communicate distress and intent to withdraw from the study, the PI will 
provide the participant with a list of Massachusetts therapists who specialize in AUD and/or 
trauma therapy and provide services in ASL, should they desire treatment outside of the research 
study. 
 
Study clinicians and Study Assessor will be trained to follow written protocols and contact 911 
in the event of a dangerous situation. The PI will also be available for on-call phone consultation 
for less urgent clinical crises. The PI will intervene if at any time a participant’s distress cannot 
be contained or in cases where anyone appeared truly unsafe (e.g., suicidal intent, threatening 
harm, or other unsafe behavior). Although it is anticipated that this reaction is highly unlikely, 
should it occur, the PI will provide debriefing and, if needed, will call for assistance.  
 
 
As the PI is a licensed psychologist, in the event that a participant is found to pose imminent 
harm to themselves or others, the PI  will implement any actions required by Massachusetts law 
with regard to individuals who are determined to pose imminent harm to themselves or others. 
Therefore, an additional risk, though highly unlikely, is that a participant would need to be 
admitted to a psychiatric inpatient hospital against his or her will. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
 
It is unlikely that we will need to withdraw participants from the study. Participants will only be 
withdrawn if they pose harm to themselves or others (i.e., physical aggression, verbal threats). 
Although this reaction is highly unlikely, should it occur, the PI would debrief the participant 
and provide referral to crisis or therapy services outside of the research study as needed. In the 
event that a participant is found to pose imminent harm to themselves or others, as a licensed 
psychologist, the PI will implement any actions required by Massachusetts law with regard to 
individuals who are determined to pose imminent harm to themselves or others. Available data 
collected prior to withdrawal will be included in statistical analyses, unless the participant 
revokes consent during the withdrawal process.  
 
16. RISKS TO SUBJECTS* 
 
There is a potential risk of loss of confidentiality. There is a potential risk of discomfort or 
increased mental health symptoms associated with completing study interventions and 

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assessments. There is also a potential risk of experiencing alcohol withdrawal symptoms. We 
address each below: 
 
 
Risks associated with potential loss of confidentiality. There is a slight risk that research 
records (e.g., assessments, video recordings) might be obtained by unauthorized persons. There 
is a slight risk that research data files might be compromised and obtained or viewed by 
unauthorized persons. Our procedures for protecting against such risks are described in Section 
26: Confidentiality.  
 
 
Risks associated with study interventions and assessments. Potential risks to participants 
include an increase in mental health symptoms while participating in Seeking Safety/Signs of 
Safety therapy, a known risk of participating in treatment in general, but not a pattern that has 
previously been identified with Seeking Safety or in the Signs of Safety one-arm pilot study. 
Rather, participants in Seeking Safety are instructed not to delve deeply into trauma details, with 
the purpose of minimizing exposure and adverse responses to trauma triggers. Additionally, 
completing study-related assessments may cause potential risk to participants, including 
discomfort, embarrassment, triggers of PTSD symptoms, or triggers of substance cravings. Every 
possible effort will be made to ensure the safety of participants. Any adverse events will be 
reported to the UMMS Institutional Review Board. Our procedures for protecting against and 
managing such risks are described in Section 14: Provisions to Monitor the Data to Ensure the 
Safety of Subjects. 
 
 
Risks associated with reductions in alcohol use. Another potential risk to participants with 
severe AUD is symptoms of alcohol withdrawal. Study clinicians and Study Assessor will assess 
withdrawal symptoms on an as-needed basis (e.g., if participants report abrupt alcohol 
discontinuation) using the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). 
Team members will be instructed to discuss minor concerns during weekly research meetings; 
moderate-to-severe concerns will immediately be discussed with the Addiction Psychiatrist, who 
will be available for on-call phone consultation. Adverse events reports will be completed and 
submitted to the UMMS Institutional Review Board.  
 
Any serious adverse events, unanticipated problems, or breaches of confidentiality that occur 
during the intervention period and/or the one-month follow-up period will be reported to the 
UMMS Institutional Review Board and the NIAAA project officer within 48 hours. 
Additionally, an annual report will be submitted to the NIAAA project officer summarizing all 
adverse events. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
 
The following potential benefits cannot be guaranteed. Potential benefits to participants include:  
• Access to an evidence-based intervention (Seeking Safety) and treatment materials 
that they may not otherwise be able to access. 
• Decrease in mental health symptoms and addiction severity. 
• Increase in safe coping skills and ability to manage their trauma symptoms. 
 

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Additionally, Deaf individuals are often not consulted for their opinions about services rendered 
within their own community. Therefore, by being asked for input on future interventions and 
services for Deaf people, participants may experience increased feelings of empowerment and 
self-efficacy.  
 
18. VULNERABLE POPULATIONS* 
 
We will not specifically recruit members of vulnerable populations. We will not knowingly 
include pregnant women as participants; however, we will not assess participants’ pregnancy 
status. 
 
19. MULTI-SITE RESEARCH* 
N/A 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
 
Community-based participatory research is a central value in the planning and execution of the 
proposed study. The majority of our research team is composed of ASL-fluent researchers and/or 
members of the Deaf community. We will also hire a Deaf Community Advisor with lived 
experience of addiction and trauma recovery to provide expertise and input on Signs of Safety 
materials. See Section 23: Resources Available for more detail on our research team.  
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
 
A summary of the research findings will be shared through conference presentations, 
publications in peer-reviewed journals, and dissemination of SPARC research products- via ASL 
videos and plain written English products (written in simple, non-academic language and 
intended to be more accessible for community members). Individual data will not be available 
for release. 
 
22. SETTING 
 
Department of Psychiatry 
The UMMS Department of Psychiatry is home to the Division of Addiction Psychiatry, whose 
mission is to enhance understanding of the causes and consequences of addictive behavior, to 
strengthen recovery and rehabilitation methodologies, to develop new approaches to treatment, 
and to share knowledge in the field across the country and around the world. The Division’s 
current research efforts include, but are not limited to, developing cognitive behavioral therapy 
protocols for various subpopulations of individuals with alcohol use disorder, treating opioid 
dependence in young adults, treating nicotine use disorder, and developing mobile technology 
for improving the lives of individuals with substance use disorder. Current initiatives are 
intended to produce novel pharmacological interventions for treatment, identify brain regions 
associated with addictive behavior and inhibitory control, and develop treatments and cessation 
techniques specifically tailored to individual needs. To achieve these aims, the Division of 
Addiction Psychiatry collaborates with partner agencies, such as Veterans Affairs, and draws on 
the rich experience of highly acclaimed faculty members – leaders in their fields – whose 

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expertise ranges from psychopharmacology, to multiculturalism and addiction, to state-of-the-art 
psychosocial intervention techniques. While collaborating with our community-based partners 
and other research and educational institutions, the Division nurtures rising academic careers in 
the study of addiction and translates evidence-based treatments into clinical care practices. 
 
Another division of the Department of Psychiatry and home of the PI’s research lab, the Systems 
and Psychosocial Advances Research Center (SPARC), is a Massachusetts Department of 
Mental Health (DMH) Center of Excellence. SPARC is an internationally-recognized academic 
center conducting research on the development, implementation, and effectiveness of behavioral 
health services. SPARC provides a collaborative environment within which to conduct 
multifaceted research. SPARC faculty and staff are a multidisciplinary team of researchers, 
psychiatrists, psychologists, sociologists, rehabilitation professionals, statisticians, trainers, 
attorneys, policy-advisors, and persons with lived mental health experience dedicated to 
preventing the development or recurrence of mental health conditions, and improving the lives of 
individuals living with these challenges. Research consultation and analytic support are available 
on a daily basis from UMMS colleagues and staff.  
 
SPARC has a strong track record of NIH funding, long-standing partnerships with many national 
foundations, and is deeply committed to state and local issues – as evidenced by our numerous 
research and training grants with various state agencies and regional foundations. In FY 2016, 
SPARC leveraged Massachusetts DMH-supported infrastructure into over $9.8 million in 
external funding for research, training, and services. Some examples of our areas of expertise 
include clubhouses through the Program for Clubhouse Research, vocational rehabilitation 
models, parenting and mental health, women’s perinatal mental health, integrated care, 
multicultural research, and wellness, including tobacco cessation and mindfulness-based 
interventions. Additionally, SPARC has strong ties in the UMMS Department of Psychiatry with 
colleagues in the Divisions of Child/Adolescent and Addiction Psychiatry, the Center for 
Comparative Neuroimaging, and the National Center on Homelessness among Veterans. Their 
partnerships also extend to Commonwealth Medicine, several other UMMS departments, and the 
UMass Boston and Lowell campuses. 
 
SPARC encourages and supports lived experience and multicultural voice in all SPARC 
activities, and contributes to the development of dissemination strategies and products targeted to 
diverse users. National dissemination activities have grown to include a newsletter, issue briefs 
available via email and on the SPARC website, and two eJournals available through the Lamar 
Soutter Library institutional repository web site. SPARC leads efforts to disseminate evidence-
based practices and information on the latest mental health research; engage academics, 
providers, and individuals with lived mental health experience in a dialogue about research and 
evaluation; and assist faculty and staff in conducting clinical research and developing research 
partnerships with community agencies. SPARC is particularly focused on non-traditional 
translation of academic research, both in target audience (i.e., individuals with lived experience 
of utilizing mental health services and their families) and mechanism (i.e., user-friendly web-
based platforms that are accessible to individuals with severe mental illness). This infrastructure 
provides the platform for knowledge translation activities that actively engage individuals with 
severe mental illness, providers and researchers. 
 

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SPARC is located on two floors of the Chang Building on the UMMS campus on Maple Avenue 
in Shrewsbury, MA. The SPARC space includes offices, break rooms, and both small and large 
conference rooms. The space is clean, modern, handicap-accessible and facilitates teamwork and 
efficiency among SPARC faculty and staff and our collaborators. SPARC’s computer hardware 
and software equipment are located in this space and SPARC employees utilize restricted access 
UMMS servers encrypted with password protection that can be accessed both on site and 
remotely (Note: When the camcorder SD card is full, study therapists will secure card in a 
password-protected lock box and mail to UMMS research staff using UPS Next Day Air 
shipping. Research staff will then download and store the data onto our secure, encrypted drive 
at UMMS.) PCs are equipped with data management programs (e.g., Microsoft Access, 
Microsoft Excel, EndNote) for data coding and storage, statistical and qualitative data analysis 
software (e.g., SAS, SPSS, N6, STATA), and desktop publishing programs (e.g., Adobe 
PhotoShop, Quark Express, Microsoft Publisher) for use in knowledge dissemination. SPARC 
and UMMS provide our faculty access to the full range of telecommunication methods, including 
web-based video-conferencing options and wireless accessibility. 
 
Department of Quantitative Health Sciences 
The UMMS Department of Quantitative Health Sciences (QHS) is the newest UMMS 
department and was conceptualized by institutional leadership in 2007 and formed in 2009 with 
the recruitment of an inaugural chair, Dr. Catarina Kiefe, and vice-chair, Dr. Jeroan Allison. Drs. 
Kiefe and Allison are nationally-known quantitative scientists who were previously at the 
University of Alabama at Birmingham (UAB). Since establishing the Department in 2009, four 
senior researchers have also been recruited to lead the Divisions of the QHS: Dr. Arlene Ash 
(Biostatistics and Health Services Research), Dr. Robert Goldberg (Epidemiology), Dr. Thomas 
Houston (Health Informatics and Implementation Science), and Dr. John Ware (Outcomes 
Measurement). The Department has a complement of approximately 35 faculty in the various 
divisions as well as nearly 80 technical and professional staff, including project managers, 
biostatisticians, and data analysts. Our Biostatistician is Research Professor in QHS and the 
Director of the UMass Quantitative Methods Core. 
 
The vision of QHS is to contribute to the health of populations and individuals and to the 
transformation of health care through methodological innovation. In particular, QHS will 
become a premier nationally and internationally recognized resource for T2/T3 research, while 
contributing to UMMS's prominence in T1 research. This includes not only bringing basic 
science progress to fruition for individual patient-level and population health, but also, in a truly 
bidirectional fashion, allowing T2/T3 research to suggest lines of basic science research with the 
potential to fill important knowledge and health care gaps.  
 
The Mission of QHS is (a) to fulfill the quantitative health science needs of the academic 
medical center to become a leader in clinical and translational research; (b) to weave service to 
the academic medical center into discovery of new approaches to address the health care needs 
of the Nation; and (c) to train the next generation of scientists to fulfill the Vision. QHS also 
houses the Quantitative Methods Core, led by our Biostatistician. The Quantitative Methods 
Core provides integrated services for study design, development of measurement tools, study 
logistics, data collection, data management, and data analysis expertise for clinical and 

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translational researchers at UMMS. QHS is housed in the newly-completed Albert Sherman 
Center, a state-of-the-art biomedical facility that was designed around QHS’ needs.  
 
Clinician Private Practices in Massachusetts 
We will recruit and train four ASL-fluent study clinicians with private practices located in 
Eastern Massachusetts, Central Massachusetts, and Western Massachusetts (for participant 
convenience). Treatment sessions will be provided in each study clinician’s private practice 
office, in direct response to findings from the PI’s NIDCD R21, which revealed Deaf people’s 
communal fear of academic research settings due to a long history of mistreatment by doctors 
and biomedical researchers (e.g., eugenics) (Anderson, Wolf Craig, & Ziedonis, 2016; Anderson 
et al., 2018; Anderson, Wolf Craig, & Ziedonis, 2017; McKee, Schlehofer, & Thew, 2013; Lane, 
2005). As such, study therapists must be independently licensed in Massachusetts and will take 
on professional liability for all the cases that they see. Proof of sufficient liability insurance will 
be obtained from each study therapist prior to beginning the pilot RCT. Study therapists will be 
compensated at hourly rates comparable to the average insurance reimbursement for individual 
therapy sessions with Deaf clients ($80 a session). 
 
23. RESOURCES AVAILABLE 
 
PI: The Principal Investigator will be responsible for the overall administration and coordination 
of the proposed research project, including participant recruitment, informed consent procedures, 
eligibility screening, data collection, data analysis, and dissemination of results. Qualifications 
include: licensed psychologist, expertise in Deaf community health and Deaf clinical research; 
ASL fluency. 
 
Study Assessor: The Study Assessor will be responsible for conducting all outcome 
assessments. Qualifications include: expertise in Deaf community health and Deaf clinical 
research; ASL fluency; proficient interview skills. 
 
Co-I/AUD Research Consultant: The Co-I/AUD Research Consultant is an expert in AUD 
research and will provide guidance and consultation on AUD RCT methodological design. 
 
Addiction Psychiatrist: The Addiction Psychiatrist will be responsible for responding to on-call 
phone consultations regarding medical concerns (e.g., withdrawal symptoms). 
 
Biostatistician: The Biostatistician will oversee all statistical aspects of the study (e.g., data 
management, analysis) and supervising the database developer and statistical analyst. 
 
Statistical Analyst: The Statistical Analyst will work under the Biostatistician to assist with all 
statistical aspects of the study (e.g., data management, analysis). 
 
Research Coordinator: The research coordinator will be responsible for assisting the PI’s with 
the overall administration and coordination of the proposed research project, including 
participant recruitment, data collection, data analysis, and dissemination of results. Qualifications 
include: 2 years of experience working as a UMMS Research Coordinator. 
 

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Fidelity Consultant: The Fidelity Consultant will be responsible for conducting fidelity ratings 
for the study. Qualifications include certification in Seeking Safety fidelity rating. 
 
Study Therapists: Four ASL-fluent study clinicians independently licensed in Massachusetts 
will provide treatment sessions to participants within their own private practice. Clinicians will 
take on professional liability for all the cases, which will be seen in their own psychotherapy 
offices. Proof of sufficient liability insurance and will be obtained from each study therapist prior 
to beginning the pilot RCT. 
 
Deaf Community Advisor: The Deaf Community Advisor (DCA) is a member of the Deaf 
community with lived experience of recovery from trauma and addiction as well as experience 
working with the PI on previous research projects. The DCA will provide consultation and 
feedback on Signs of Safety toolkit and create recruitment materials. The DCA will not have 
contact with participants or access to study data.    
 
PTSD Research Consultant: The PTSD Research Consultant will not have contact with 
participants or access to study data. 
 
Exit Interviewer: The Exit Interviewer will conduct optional exit interviews that take place after 
all study procedures are completed. The exit interview will focus on participants’ experience the 
research study, including logistics, accessibility, communication, and technology. 
 
All study staff will be CITI trained and either added to the Project Personnel tab in eIRB or 
submitted to the IRB office with HRP-215 Non-UMass Personnel Form. 
 
24. LOCAL RECRUITMENT METHODS 
 
We will recruit participants using ASL YouTube videos and plain English flyers disseminated on 
Deaf listservs (e.g., MassDeafCare, MassDeafTerp), Deaf Facebook groups (e.g., The Voice of 
the Deaf Community in MA, MA Commission for the Deaf and Hard of Hearing, MA State 
Association of the Deaf), and sent to local Deaf-specialized agencies (e.g., Center for Living & 
Working, Deaf Inc., Advocates, Alternatives, Our Deaf Survivors Center, North Suffolk Mental 
Health, Northeast Independent Living Program). The PI has used these methods successfully in 
five previous and ongoing studies involving Deaf research participants. Please note that 
recruitment materials for the proposed study (ASL YouTube videos, flyers) will be created using 
expertise of the Deaf Community Advisor and, therefore, will be submitted to the UMMS IRB as 
a modification.  
 
25. LOCAL NUMBER OF SUBJECTS 
 
We will enroll 60 Deaf adults from Massachusetts. Based on pilot results, we anticipate at least 
45 participants will be retained through immediate post-treatment (60 enrolled participants x a 
conservative 0.75 retention rate), or 22 participants per treatment arm. This post-attrition sample 
size falls within the guidelines for a pilot RCT behavioral therapy study - “15 to 30 participants 
per cell” - and is “based on the pragmatics of recruitment and the necessities for examining 
feasibility.”  

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26. CONFIDENTIALITY  
 
Every effort will be made to protect participants’ confidentiality. Only members of the research 
team (except for the Deaf Community Advisor and PTSD Research Consultant) will have access 
to identifying information, which will be kept separate from participant data. An NIH Certificate 
of Confidentiality will be obtained to protect participants from disclosure of sensitive data, 
especially information related to substance use, similar to procedures used for the Signs of Safety 
one-arm pilot study. Any breach of confidentiality will be reported to the UMMS Institutional 
Review Board. 
 
 
All intervention sessions will be videotaped by study clinicians. The video camcorders will be 
stored in locked file drawers in locked therapy offices. When the camcorder SD card is full, the 
study therapists will secure the SD card in a password-protected lock box and mail to UMMS 
research staff using UPS Next Day Air shipping. Research staff will then download and store the 
data onto our secure password-protected, encrypted internal server hosted within the UMMS 
Systems and Psychosocial Advances Research Center (SPARC). Video recordings of 
intervention sessions are for fidelity testing only and will not be used for participant data 
collection; as such, the recordings will not be transcribed. Video recordings of the exit interview 
will be used for data analysis only. Any results will be reported by overall themes across 
participants; data will not be individually tied to specific participants. 
 
All data will be entered into Research Electronic Data Capture (REDCap), a secure, web-based 
application designed exclusively to support data capture for research studies.  REDCap is hosted 
locally by UMMS and employs user authentication and role-based security. The REDCap 
application resides in an isolated secure network segment designed for PHI, PII, and other types 
of regulated data. Web-based data entry is via an SSL cryptographic transport protocol. 
Additional security procedures are in place for data access. The environment logs are audited by 
IS. Paper data will be stored in locked file cabinets in locked offices. 
 
At the end of each treatment session, participants will complete the Seeking Safety End of 
Session Questionnaire via the web-based REDCap Survey interface using a 32GB 12.9inch iPad 
Pro that will be provided to each study clinician for the duration of the study. (These iPads will 
also be used to of show Signs of Safety video materials to participants.) Both the REDCap 
database and the iPad will be password-protected. 
 
Data will be exported to SAS and ATLAS.ti for quantitative and qualitative analysis, respectively. 
All analytic files will be stripped of personal identifiers. Only CITI-trained personnel with 
appropriate authorization and relevant project need will be allowed data access. All paper 
records, video recordings, and electronic data records will be destroyed three years after 
completion of the grant period, in accordance with NIH policy. Individual data will not be 
available for release. 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
 

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During the informed consent process, participants will be informed that they have the right to 
refrain from answering any questions. It will be emphasized that any information provided by the 
participant is completely voluntary and that they can leave the study at any time if they choose.  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
 
Prior to the beginning of the study, participants will be informed that there is no available 
compensation for research-related injury. This information will also be located on the Informed 
Consent Form. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
 
We do not anticipate economic burden to participants. Our proposed method of remote 
videophone assessment is responsive to Deaf people’s transportation barriers, financial barriers, 
and technology preferences. This method was used successfully in the Signs of Safety pilot study 
and previous studies with Deaf individuals. With clinicians in Eastern, Central, and Western 
MA, maximum travel time from highly Deaf-populated towns (e.g., Boston, Framingham, 
Springfield) to an available treatment site is less than 30 minutes. Such travel time will not be a 
barrier to recruitment and retention as this population is accustomed to traveling lengthy 
distances to receive treatment due to the rarity of Deaf-accessible providers. 
 
30. CONSENT PROCESS 
 
Interested individuals will be offered a one-hour videophone appointment during which the PI 
will conduct informed consent procedures. The PI will follow the UMMS Investigator Guidance 
for Informed Consent (HRP-802). 
 
Prior to the call, the PI will provide each participant with an electronic copy of the IRB-
approved, written English informed consent form (e-Consent) via Research Electronic Data 
Capture (REDCap). During the call, the PI will present each section of the e-Consent form in 
ASL (e.g., “What are the risks of being in this study?”, “What happens to information about 
me?”), pausing after each section for questions and discussion. Individuals who wish to enroll 
will sign the e-Consent form in REDCap, by typing in their name or using the “wet signature” 
feature. Rather than conduct informed consent in person, which would require study staff to 
travel across the state of MA, e-Consent is a newly evolving platform that can be leveraged to 
overcome these logistical barriers. e-Consent can be accessed by participants via computer, 
mobile phone, or tablet. 
 
Individuals who consent to participate will then be immediately screened by the PI to determine 
eligibility. 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
 
The PI will follow the UMMS Investigator Guidance for Documentation of Informed Consent 
(HRP-803). Written informed consent will be documented electronically using an e-Consent 
form via REDCap, a HIPAA-compliant, web-based electronic capture database. All study 

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procedures, potentials risks, and benefits will be explained in detail by the PI in ASL prior to 
obtaining written consent.  
 
32. DRUGS OR DEVICES  
N/A