Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
Phase: NA
Conditions: Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior, Stress, Relationship, Social, Sexual Assault, Sexual Violence, Social Interaction
Sponsor: University of Washington

CARE Trial Protocol 
***Reporting guidelines taken from SPIRIT 2013 statement*** 

Administrative Information 
1. Title
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual 
Assault Survivors (CARE) 
2. Trial registration
2a. Trial identifier and registry name 
If not yet registered, name of intended registry 
ClinicalTrials.gov ID: NCT05345405 
3. Protocol version
Date:  
April 14, 2025 
Version:  
4 
4. Funding
(Sources and types of financial, material, and other support)
Department of Justice, Office on Violence Against Women Grant #2020-SI-AX-0007 
5. Roles and responsibilities
5a. Names, affiliations, and roles 
Name 
Study Role 
Affiliation 
Emily Dworkin 
Principal Investigator 
UW 
Michele Bedard-Gilligan Co-Investigator 
UW 
JP Santos 
Research Coordinator 
UW 
Margee Quinn 
Research Coordinator 
UW 
Jenna Mohr 
Research Assistant 
UW 
Carolina Ibarra 
Research Assistant 
UW 
Angela Simler 
Research Assistant 
UW 
Jenna Mohr 
Research Assistant 
UW 
Maddie Lacoste 
499 Research Assistant 
UW 
Sarah Ton 
499 Research Assistant 
UW 
Olivia Baldwin 
499 Research Assistant 
UW 
Abril Beretta 
Volunteer Research Assistant 
UW 
Skye Fitzpatrick 
Advisory Board Member- Researcher 
York University 

Rebecca Campbell 
Advisory Board Member- Researcher 
Michigan State 
Josef Ruzek 
Advisory Board Member- Researcher 
Retired 
Matthew Cordova 
Advisory Board Member- Researcher 
Palo Alto University 
Tara Wolfe 
Advisory Board Member- Practitioner 
FORMERLY- WA Office of Crime Victim 
Advocacy 
Richard Torrance 
Advisory Board Member- Practitioner 
WA Office of Crime Victim Advocacy 
Terri Stewart 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Annette Simpson 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Laura Merchant 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
George Gonzalez 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Whitney Hellyer 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Candice L Orfao 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Maria Lee 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Roshelle Cleland 
Advisory Board Member- Practitioner 
Lutheran Community Services Northwest 
Millini Goodman 
Advisory Board Member- Practitioner 
Lutheran Community Services Northwest 
Vanya Nanda 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Minu Ranna-Stewart 
Advisory Board Member- Practitioner 
Harborview Abuse and Trauma Center 
Natalia Garcia 
Inclusivity Consultant 
UW/Seattle VA 
Isha Metzger 
Inclusivity Consultant 
University of Georgia 
Natalie Watson-Singleton Inclusivity Consultant 
Spelman University 
Soo Jeong Youn 
Inclusivity Consultant 
Massachusetts General Hospital / Harvard Medical 
School 
 
5b. Name and contact information for the trial sponsor 
N/A 
5c. Role of study sponsor and funders 
OVW has no role or ultimate authority in the study design, collection, analysis or 
interpretation of the data, writing the report, or the decision to submit the report for 
publication. 
5d. Composition, roles, and responsibilities  
Composition, roles, and responsibilities of the coordinating centre, steering committee, 
endpoint adjudication committee, data management team, and other individuals or 
groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) 
N/A 
 
 

Introduction 
 
6. Background and rationale 
6a. Description of research question and justification for undertaking the trial 
Including summary of relevant studies (published and unpublished) examining benefits 
and harms for each intervention 
Sexual assault is a common form of trauma: approximately 36% of women, 17% of 
men, and 34–47% of transgender and gender diverse individuals are sexually assaulted 
in their lifetime. Three quarters of survivors have elevated symptoms of posttraumatic 
stress disorder (PTSD) one month after sexual assault. Natural recovery of PTSD 
symptoms is common, but 41% of survivors still have PTSD 12 months later. There is 
evidence that early interventions— those delivered within 3 months of trauma—are 
effective. Early interventions have reduced PTSD severity among sexual assault 
survivors. Existing early interventions focus only on sexual assault survivors and do 
not target the social contexts in which survivors’ recovery occurs. However, these 
social contexts are important to recovery. Nearly all survivors seek help from 
supporters (e.g., friends, family, romantic partners), often soon after assault. 
Unfortunately, most survivors receive negative reactions when they seek help, and 
these reactions increase risk for psychopathology. Importantly, supporters do not 
necessarily respond in negative ways with malicious intent, but instead due to a lack of 
knowledge about effective responses, a lack of knowledge about survivors’ 
preferences, or difficulty managing their emotional reactions. To our knowledge, one 
prior preventative intervention has aimed to improve responses to disclosures. 
Supporting Survivors and Selves trained groups of undergraduate students in support 
skills in anticipation of receiving a future disclosure of interpersonal violence. In a 
randomized clinical trial, this intervention led to improvements in intended responses 
but did not change actual responses among those who prospectively received a 
disclosure. There is currently no empirically-supported intervention to improve 
supporters’ ability to respond effectively to survivors in the immediate aftermath of 
sexual assault and thereby improve survivors’ downstream outcomes. We created 
CARE (Communication and Recovery Enhancement) to address the lack of early 
interventions to improve supporters’ responses. CARE is intended for survivors of 
past-10-week sexual assault and a support person of their choice. It involves two 
telehealth sessions with a clinician and a supporter, with the survivor present (dyadic 
version) or without the survivor present (supporter-only version). 
6b. Explanation for choice of comparators 
This pilot randomized clinical trial uses a unmasked, prospective, parallel group, 
superiority design.  
Participants are allocated 1:1:1 (unstratified) to dyadic CARE, supporter-only CARE, 
or waitlist control. Assessments are completed via self-report at baseline, post session 
1, and 1, 2, and 3 months postbaseline. 
 

7. Objectives  
(Specific objectives or hypotheses) 
The goal of this protocol is to describe our methods for a pilot randomized clinical trial of 
dyadic and supporter-only CARE. Our goals are to understand feasibility, acceptability, and 
preliminarily characterize efficacy. We hypothesize: ​
H1: Dyadic and supporter-only CARE will be rated as acceptable by survivors and supporters 
at 1-month follow-up. 
H2: Dyadic and supporter-only CARE will lead to increases in survivor 
and supporter knowledge from baseline to 1-month follow-up. 
H3: Dyadic and supporter-only CARE will improve disclosure experiences 
(i.e., increasing survivor disclosure frequency, reducing supporter 
negative reactions, increasing supporter responsiveness) at 1- 
month follow-up compared to waitlist. 
H4: Dyadic CARE and supporter-only CARE will improve functional 
outcomes among survivors (i.e., PTSD, stress, relationship quality) and 
supporters (i.e., stress, relationship quality) at 3-month follow-up 
compared to waitlist. 
 
8. Description of trial design  
Type of trial  
(eg, parallel group, crossover, factorial, single group) 
Parallel group, three arm 
Allocation ratio 
1:1:1 
Framework  
(eg, superiority, equivalence, noninferiority, exploratory) 
Superiority 
 
 

Methods: Participants, Interventions, and Outcomes 
 
9. Study setting 
Description of study settings 
Remote 
Reference to where list of study sites can be obtained 
N/A 
 
10. Eligibility Criteria 
Inclusion criteria 
Inclusion Criteria (Survivors): 
●​ Age 14+ years 
●​ Can speak/read English or Spanish 
●​ Have access to a Zoom-capable device 
●​ Screened for eligibility within 10 weeks of sexual assault, defined as any 
unwanted, distressing sexual contact (e.g., unwanted touching, coerced sexual 
activity, rape) 
●​ Able to attend first study session within 2 weeks of screening 
●​ Elevated PTSD symptoms at screening as operationalized by a Primary Care 
PTSD Screen score of 2/5 or above 
●​ Able to identify an eligible supporter 
●​ Have a way to receive survey links and complete surveys privately (i.e., without 
potential device or account access by the supporter) 
Inclusion Criteria (Supporters): 
●​ Age 14+ years 
●​ Can speak/read English or Spanish 
●​ Have access to a Zoom-capable device 
●​ Able to attend first study session within 2 weeks of survivor's screening 
●​ Are in contact with the survivor at least once a week 
●​ In the opinion of the survivor, are able to make an independent decision about 
whether or not to participate in the study 
●​ Have a way to receive survey links and complete surveys privately (i.e., without 
potential device or account access by the survivor) 
Exclusion criteria 
Exclusion Criteria (Survivors): 
●​ Active psychosis 
●​ Active suicidal intent 

Exclusion Criteria (Supporters): 
●​ Perpetrated the sexual assault 
●​ Engaged in severe past-year violence or abuse (as defined by the survivor) 
against the survivor 
●​ The survivor has not told the supporter about the sexual assault at the time of 
screening and was not already planning to tell the supporter 
●​ In the opinion of the survivor, relational conflict exists between the survivor 
and supporter that potentially could be exacerbated by program participation 
Eligibility criteria for study centers (if applicable) 
N/A 
Eligibility criteria for individuals who will perform the interventions 
The intervention will be delivered by either the principal investigator (a licensed 
clinical psychologist) or a staff member trained by the principal investigator 
 
11. Interventions 
11a. Interventions for each group with sufficient detail to allow replication, 
including how and when they will be administered 
Intervention 
Both telehealth sessions will be 90 min and will be delivered using a slide deck 
and a script. Sessions will be audio recorded for supervision and fidelity 
tracking. Clients will be sent an electronic and/or paper workbook following 
session 1. The clinician will complete a clinical note regarding content coverage 
and clinical observations. In session 2, the note will document attendance, 
homework completion, and skills practice. We will also assess homework 
completion and skills practice via survivor and supporter self-report at 1-month 
follow-up. 
 
Dyadic CARE 
Dyadic CARE involves two telehealth sessions with a clinician, the survivor, 
and a supporter of the survivor's choice. Session content uses 
cognitive-behavioral strategies (e.g., encouraging non-avoidance) to encourage 
communication and improve supporters' responses in trauma-related 
conversations. Between sessions, both the survivor and the supporter are 
instructed to review session content and have guided discussions with the 
assistance of a workbook. 
 
Supporter-Only CARE 
Supporter-only CARE involves two telehealth sessions with a clinician and a 
supporter of the survivor's choice, without the survivor present. Session content 
uses cognitive-behavioral strategies (e.g., encouraging non-avoidance) to 

encourage communication and improve supporters' responses in trauma-related 
conversations. Between sessions, both the survivor and the supporter are 
instructed to review session content and have guided discussions with the 
assistance of a workbook. 
 
Comparison 
Waitlist Control 
After completing baseline, participants will be invited to schedule a CARE 
session in 3 months (i.e., after the completion of all study assessments). The 
version of CARE received at that point will be selected by the survivor. 
Participants will complete self-report assessments at post-session-1, Month 1, 
Month 2, and Month 3.  
11b. Criteria for discontinuing or modifying allocated interventions for a given trial 
participant 
Participants who withdraw consent for participation will no longer be contacted by 
study staff or sent automated reminders to complete study tasks.  
 
Participants will be withdrawn from the research if at any point if it becomes known 
that a participant does not meet eligibility criteria for the study, if a participant’s 
condition deteriorates, or if it becomes known that they require a higher level or 
different type of care that is incompatible with study participation.  If this occurs, 
participants will be asked to withdraw from the study and appropriate referrals will be 
made. 
  
Once enrolled, both survivors and supporters may choose to opt out of all study 
questionnaires and still receive the intervention, although they will not be paid for 
questionnaires. Survivors and supports are permitted to individually withdraw without 
affecting the eligibility of the other participant (i.e., if a survivor withdraws or cannot 
be reached, the supporter may still receive the intervention and be paid for 
questionnaires), but the survivor participant may request to withdraw both themselves 
and their supporter from the study at any time. 
11c. Strategies to improve adherence to intervention protocols, and any procedures 
for monitoring adherence 
All assessments will occur via online self-report surveys. These will be auto-generated 
from our secure online system, and participants will receive reminders from the 
clinician within one week of not completing surveys, to remind participants to submit 
their answers. Survivors and supporters will be paid $10, $10, $20, $30, and $40 for 
baseline, post-session-1, 1-month, 2-month, and 3-month assessments, respectively 
(total possible per person: $110). Participants may choose to be paid via preloaded 
debit card or emailed gift card. 
 

Staff will do weekly checks and audits of all study interactions & documentation to 
ensure protocol adherence.  
11d. Relevant concomitant care and interventions that are permitted or prohibited 
during the trial 
Participants will not be restricted from accessing any care or interventions during the 
course of the trial. It is likely that individuals recruited from the Harborview Abuse and 
Trauma Center and other key recruitment sites will receive treatment for 
sexual-assault-related distress while enrolled in the study. 
 
12. Outcomes 
 
See ClinicalTrials.gov 
 
13. Participant timeline  
(A schematic diagram is highly recommended) 

 
14. Sample size 
Estimated number of participants needed to achieve study objectives 
60-72 dyads (120-144 participants) 
How sample size was determined 
Including clinical and statistical assumptions supporting any sample size calculations 
As this is a pilot trial, the sample size was selected primarily for feasibility rather than 
significance testing. 

 
15. Recruitment 
Recruitment sites and procedures; site-specific and general strategies for achieving adequate 
participant enrollment to reach target sample size 
Our primary partnership is with a sexual assault nurse examiner (SANE) program embedded in 
a large, urban level 1 trauma center that conducts SANE exams in the emergency department 
and schedules all patients for follow-up visits with a SANE and social worker 1-2 weeks later. 
SANEs and social workers pass out study flyers to patients and their supporters in the 
emergency department and at follow-up visits. Research staff are available on site at follow-up 
visits so that interested survivors could be screened as part of their visit. We also reached 
non-treatment-seeking survivors via mass emails to the enrolled student body at the University 
of Washington. 
 
 

Methods: Assignment of Interventions (for Controlled Trials) 
 
16. Allocation 
16a. Sequence generation 
Participants will be randomly assigned to intervention or control via a 
computer-generated randomization schedule. Randomization will not be stratified.  
16b. Allocation concealment mechanism 
The participant management system will not reveal the randomization condition until 
the patient has completed all baseline measures. 
16c. Implementation 
The web developers responsible for hosting the surveys and participant management 
site (Rivulent Web Design) will generate the allocation sequence. The study clinician 
assigned to the dyad will enroll participants and assign them to interventions. 
 
17. Blinding (masking) 
17a. Who will be blinded after assignment to interventions (eg, trial participants, 
care providers, outcome assessors, data analysts), and how 
Due to the nature of the intervention, neither participants nor study staff can be blinded 
to allocation. Baseline and follow-up assessments will occur via self-report; thus, no 
blinding of clinical assessors is needed.  
17b. If blinded, circumstances under which unblinding is permissible, and 
procedure for revealing a participant’s allocated intervention during the trial 
N/A 
 

Methods: Data Collection, Management, and Analysis 
 
18. Data collection methods 
18a. Plans for assessment and collection of outcome, baseline, and other trial data 
Including any related processes to promote data quality (eg, duplicate measurements, 
training of assessors) and a description of study instruments (eg, questionnaires, 
laboratory tests) along with their reliability and validity, if known. Reference to where 
data collection forms can be found, if not in the protocol 
All assessments will occur via online self-report surveys. Survey invitations and 
reminders will be sent via email or text message. Participants will complete follow-up 
questionnaires after session 1 and at 1, 2, and 3 months post-baseline to assess changes 
in knowledge, disclosure, and symptoms. We selected these time points because 
recovery occurs most rapidly within the first 3 months post-assault (Dworkin et al., 
2021).  
Survivors and supporters will be paid $10, $10, $20, $30, and $40 for baseline, 
post-session-1, 1-month,  2-month, and 3-month assessments, respectively (total 
possible per person: $110). Participants may choose to be paid via preloaded debit card 
or emailed gift card and will be provided with referrals. 
18b. Plans to promote participant retention and complete follow-up 
List of any outcome data to be collected for participants who discontinue or deviate from 
intervention protocols 
The following steps will be taken to promote retention: 
●​ We will collect extensive contact data from participants and attempt to reach 
them for all follow-up assessments unless directed otherwise. 
●​ Participants will receive text, email, and/or phone call reminders to complete 
the study surveys.  
●​ Survivors and supporters will be paid $10, $10, $20, $30, and $40 for baseline, 
post-session-1, 1-month, 2-month, and 3-month assessments, respectively (total 
possible per person: $110). Participants may choose to be paid via preloaded 
debit card or emailed gift card. 
●​ The study clinician will emphasize the importance of completing study surveys. 
●​ The study clinician will instruct participants to complete the post-intervention 
survey once they terminate the initial CARE appointment. 
 
19. Data management 
Plans for data entry, coding, security, and storage 
Including any related processes to promote data quality (eg, double data entry; range 
checks for data values). Reference to where details of data management procedures can 
be found, if not in the protocol. 
Entry and coding 
Data will be completely digital; no data entry will be needed. In some cases, 
scale scores will be automatically calculated by custom programming. When this does 

not occur, study staff will create SPSS syntax and a data dictionary referencing scoring 
procedures.  
Security and storage 
All data will be identified only by a Personalized Identification Number (PIN). 
Data will be collected using a secure server supporting 128-bit encryption. This level of 
encryption provides the highest level of protection against hackers, computer break-ins, 
etc. The CSHRB owns a secure server (hosted by Digital Fortress, Inc.) to which 
participants log in using a unique PIN created for study purposes. IP address is not 
stored, and data are identified only by the PIN, not the participant’s name. Data transfer 
will be protected using a Secure Socket Layer with 128-bit encryption (internet security 
provided by VeriSign). This is the same level of encryption used for online banking 
transactions. The server is physically located in a secure, commercially protected 
co-location facility with 24 hour locked and monitored key-card access, within a 
locked room, within a locked server rack, with a locking face-plate protecting the 
server itself from physical access without authorization. Electronic protection is 
provided by a commercial-grade firewall, with continuous monitoring of the server for 
any attempts at electronic invasion. The password to the account will only be known to 
the Principal Investigator, Mentors, and other relevant research staff. All data stored in 
the online repository will be encrypted using the official Advanced Encryption 
Standard (AES) algorithm and with a 128-bit key length. A master list of names and 
code numbers will be stored on a password-protected computer under the supervision 
of the Principal Investigator, and will be available only to research staff on this project. 
Research assistants will receive training that includes emphasis upon the 
importance of confidentiality of information, and all personnel on the project 
(including graduate and undergraduate research assistants and study staff) will 
complete the required NIH training in protection of human research participants. All 
staff will sign confidentiality statements. Data will be retained on computers with 
restricted and password protected access, without links to the master code list. All data 
based on this research will be reported in aggregate form. No individual respondents 
will be identified. The link between identifiers and the research data will be destroyed 
after the records retention period required by state and/or federal law. 
 
20. Statistical methods 
20a. Statistical methods for analyzing primary and secondary outcomes 
Reference to where other details of the statistical analysis plan can be found, if not in the 
protocol 
Analyses will be conducted with the intent-to-treat sample. As this study is not 
powered to detect statistical significance, we will examine the direction and magnitude 
of effects to preliminarily understand efficacy and test significance in an exploratory 
manner only. Within-group ds will be calculated as the mean-level difference in scores 
from baseline to follow-up for each condition divided by the standard deviation of 
change scores. Between-group ds will represent relative change between conditions 
and will be calculated as the difference between within-group ds. 

 
Acceptability (H1) 
We will use descriptive statistics to summarize acceptability ratings among dyads 
randomized to dyadic or supporter-only CARE. We will use independent-samples 
t-tests and between-group ds to compare acceptability by condition. 
 
Efficacy (H2–4) 
We will calculate within- and between-group ds to represent mean changes on focal 
outcomes. We will use the reliable change index to quantify whether change is unlikely 
to be attributable to measurement error, and we will report odds ratios for differences in 
percent with reliable improvement by condition. We will also report the percent of 
participants meeting diagnostic criteria based on the PCL at baseline and 
3-month follow-up.​
 
Paired sample t-tests will evaluate mean changes from baseline to follow-up. We will 
test time-by-condition interactions in random-effects models using maximum 
likelihood estimation to account for missing data. We will test covariates including 
relationship type, study clinician, participant age, and prior assault history. We will 
conduct sensitivity analyses with English and Spanish-language participants separately. 
20b. Methods for any additional analyses  
(eg, subgroup and adjusted analyses) 
We will test moderation and visually examine results across groups as a function of: 
●​ Baseline PTSD severity and PCL score > cutoff of 33 
●​ Relationship type (friend, parent, partner, other) 
●​ Caregiver burden (Impact on Friends - Ineffectiveness Subscale) 
 
We will conduct sensitivity analyses in the following samples: 
●​ English speakers only 
20c. Analysis population and missing data 
Definition of analysis population related to nonadherence (eg, as randomized analysis), 
and any statistical methods to handle missing data (eg, multiple imputation) 
We will use an intent to treat analysis, in which participants will be retained in 
the group to which they were originally randomized. Outcome data from all 
participants will be included in analyses. We will also explore the use of 
randomization-based efficacy estimators (White, 2005). 
 

Methods: Monitoring 
 
21. Data monitoring 
21a. Data monitoring committee 
Composition of data monitoring committee (DMC) 
N/A 
Summary of its role and reporting structure 
N/A 
Statement of whether it is independent from the sponsor and competing 
interests 
Reference to where further details about its charter can be found, if not in the 
protocol 
N/A 
Alternatively, an explanation of why a DMC is not needed 
Given that this is a pilot trial of an intervention with minimal risks, we will not 
retain a data monitoring committee. 
21b. Description of any interim analyses and stopping guidelines 
Including who will have access to these interim results and make the final decision to 
terminate the trial 
No interim analyses will be conducted.  
We will employ the following stopping rule for the clinical trial: if there is clear 
evidence of harm. Although we do not expect any physical harms or serious 
psychological harms beyond minimal distress, we have several procedures for 
monitoring harm from the intervention, including asking participants to contact us if 
they experience any adverse events, offering additional resources to those with very 
high levels of mental health symptoms and problem drinking that we identify through 
data monitoring, and providing resources after baseline and at every follow-up time 
point. We do not expect there to be overwhelming evidence of the harm of the 
intervention, but we will monitor this and stop the trial if this is indicated. We also do 
not expect that there will be no likelihood of demonstrated treatment benefit (futility) 
for the intervention as compared to control. 
 
22. Harms 
Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported 
adverse events and other unintended effects of trial interventions or trial conduct 
All participants will be fully informed of how to contact the investigators and/or the UW IRB 
to report complaints or adverse events via explicit instructions in the consent form. The PI and 
co-I Bedard-Gilligan are well-versed in the requirements and procedures for monitoring and 
reporting adverse events and complaints to the IRB for review. Dr. Bedard-Gilligan has 
managed this process as PI of several previous clinical trials and will work closely with Dr. 

Dworkin to provide guidance and consultation in this process. All adverse events will be 
reviewed by Dr. Dworkin and other members of the treatment team to determine the 
seriousness of the adverse events. The PI and co-Is have a wealth of experience in managing 
adverse psychological events both in the context of clinical trials research and clinical practice 
and are competent to handle any adverse psychological events which may arise. We will 
follow institutional policies for reporting serious adverse events (SAEs) and adverse events 
(AEs) to the IRB and OVW. On a daily basis, Dr. Dworkin will be responsible for data and 
safety monitoring and will provide continuous, close data monitoring. Dr. Dworkin will follow 
UW’s SAE reporting policy in promptly reporting SAEs to the UW Institutional Review Board 
(IRB) and to OVW. Dr. Dworkin will report all SAEs to the IRBs within 24 hours. A report of 
all non-serious adverse events will be provided to the IRB yearly. The PI and co-Is will meet 
twice a year regarding safety and monitoring procedures. This meeting will be used to review 
any problems in implementing procedures. Dr. Dworkin will also monitor safety data as part of 
the yearly review. Safety evaluations will include AEs and longitudinal symptom measures. 
Safety evaluations will also consider factors external to the study, such as scientific or 
therapeutic developments that may have an impact on the safety of the participants or the 
ethics of the study.    
 
23. Auditing 
Frequency and procedures for auditing trial conduct, if any, and whether the process will be 
independent from investigators and the sponsor 
No auditing will be conducted. 
 
 

Ethics and Dissemination 
 
24. Research ethics approval 
Plans for seeking research ethics committee/institutional review board (REC/IRB) approval 
We have obtained ethical approval from the University of Washington IRB.  
 
25. Protocol amendments 
Plans for communicating important protocol modifications (eg, changes to eligibility criteria, 
outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial 
registries, journals, regulators) 
Any modifications to the protocol which could impact the conduct of the study, potential 
benefits to the participants or participant safety, including changes to study objectives, study 
design, target population, sample sizes, study procedures, or significant administrative aspects, 
will require a formal amendment to the protocol. This amendment will be approved by the 
study PI and the IRB prior to implementation. 
 
Administrative changes (i.e., minor corrections and/or clarifications that have no effect on the 
way the study is conducted) will be documented by the PI, and approved by the IRB if 
necessary. 
 
26. Consent or assent 
26a. Who will obtain informed consent or assent from potential trial participants or 
authorized surrogates, and how (see Item 32) 
During the phone screening, the research staff person will explain the screening process 
and the broader study and obtain verbal informed consent for screening from the 
survivor. The study clinician will obtain verbal informed consent at the initial study 
appointment from both dyad members. Both dyad members will then complete a 
separate electronic consent form on their own before the baseline assessment that again 
presents information about the broader study and involves consent to be randomized 
and participate in the intervention.  
26b. Additional consent provisions for collection and use of participant data and 
biological specimens in ancillary studies, if applicable 
N/A 
 
27. Confidentiality 
How personal information about potential and enrolled participants will be collected, shared, 
and maintained in order to protect confidentiality before, during, and after the trial 
We have taken precautions to ensure that privacy is protected. 
●​ Participants will be told that they can decline to answer any questions they do 
not want to answer. 

●​ Data will be collected using a secure server. IP address will not be stored, and 
data will be identified only by the PIN, not the participant’s name. Data transfer 
will be encrypted with the same level of encryption used for online banking 
transactions. The password to the account will only be known to the Principal 
Investigator, Co-Investigators, and research coordinator. 
●​ Electronic data will be stored in secure servers and accessed only via a 
password-protected interface. Direct identifiers will be stored separately from 
research data, and linked only with an ID number. The linkage code will be kept 
in a computer file with restricted access and will not be available to the public 
or individuals not directly involved in the research. We will maintain the link 
for 1 year after the end of the study to ensure that all data are accounted for and 
no further subject contact is required. Only members of the research team will 
have access to the data, with the research team signing confidentiality 
agreements. Computer data will be stored on a main server that is firewall and 
password protected, with appropriate back up procedures in place. No names 
will be associated with study data or with published reports, which will only 
contain data in aggregated form. Access to subject data will be limited to study 
staff, on an as-needed basis, for research purposes only. We need to retain 
contact information (e.g., phone numbers, emails) in order to contact 
participants for follow-up assessments. We will retain this contact information 
in a password protected computer system. These data will not be shared with 
individuals who are not directly involved in the study. 
●​ The research team will not have access to survivor files for recruitment 
purposes and will not be involved in identifying or initiating contact with 
participants. Instead, clinical staff who already have access to survivor files as 
part of their regular clinical duties will be responsible for identifying potential 
participants and informing them about the study, while staying independent 
from enrollment, consent, intervention delivery, and data collection procedures. 
●​ All participants will be informed of exceptions to confidentiality (i.e., current, 
imminent suicidality/homicidality; current child abuse, elder abuse) both 
verbally and in the written consent form at their initial baseline evaluation. 
Participants will be informed that in cases of reported current threat to safety to 
either self or others, or abuse of a vulnerable population, mandatory reporting 
laws apply, and confidentiality may be broken in order to ensure safety. There 
will be no subject identifying features on entered data. 
●​ We will be covered by a Privacy Certificate from the National Institute of 
Justice. This certificate offers the highest protection available by law for 
research data. 
●​ Research assistants will receive training that includes emphasis upon the 
importance of confidentiality of information, and all personnel on the project 
(including graduate and undergraduate research assistants and study staff) will 
complete the required NIH training in protection of human research 
participants. 
●​ Participants will be instructed to complete telehealth sessions in a private 

location, and privacy will be verbally verified with participants by study staff 
before the session begins. Participants will be instructed to not say names 
during study sessions. Zoom appointments will take place on a 
HIPAA-compliant platform and the waiting room feature will be used to 
prevent unauthorized access. 
 
28. Declaration of interests 
Financial and other competing interests for principal investigators for the overall trial and each 
study site 
None 
 
29. Access to data 
Statement of who will have access to the final trial dataset, and disclosure of contractual 
agreements that limit such access for investigators 
 
 
30. Ancillary and post-trial care 
Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer 
harm from trial participation 
N/A 
 
31. Dissemination policy 
31a. Plans for investigators and sponsor to communicate trial results  
To participants, healthcare professionals, the public, and other relevant groups (eg, via 
publication, reporting in results databases, or other data sharing arrangements), 
including any publication restrictions 
Results will be presented in peer-reviewed journal articles (with appropriate deposit in 
publicly-accessible databases as required as a condition of DOJ funding), conference 
presentations, and community presentations.  
31b. Authorship eligibility guidelines and any intended use of professional writers 
The research team will adhere to the American Psychological Association’s (2001) 
publication credit guidelines for authors (p. 350-351; Principle 6.23, a-c). 
  
Authorship order is based on scientific contributions to the research and the 
manuscript.  Proposed authorship order is subject to renegotiation if an author fails to 
fulfill his/her agreed upon role in a timely manner. If the manuscript has not progressed 
within 6 months of the date of this agreement, the data return to the authorship pool 
and another author may be designated to take the lead on the paper. 

31c. Plans, if any, for granting public access to the full protocol, participant-level 
dataset, and statistical code 
No plans to grant public access. 
 
 

Appendices 
 
32. Informed consent procedures 
Model consent form and other related documentation given to participants and authorised 
surrogates 
33. Biological specimens 
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or 
molecular analysis in the current trial and for future use in ancillary studies, if applicable 
N/A 
 
 
 

Survivor Consent Form 
1 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
 UNIVERSITY OF WASHINGTON 
Survivor Consent Form (Stage 2) 
KEY STUDY INFORMATION 
We are asking whether you want to consent to participate in a research study. The research study 
aims to understand whether a program is helpful to survivors and their supporters.  
Participation involves:   
1. Two ~90 minute telehealth CARE program appointments that focus on how you and your 
supporter can communicate in ways that may help you recover. You will be randomly selected 
to get the program in one of three ways: 
a. Option 1: You and your supporter attend the program appointments together starting 
today. The first 90-minute appointment would start after your finish your questionnaires, 
so your entire appointment time today would be ~2.5 hours. You will both get a workbook 
to work on together after your appointment. 
b. Option 2: Your supporter attends the program appointments alone starting today and will 
be asked to meet with you to teach you about what they learned using a workbook that we 
will give both of you.  
c. Option 3: You choose which version of the program you want, and you get it in 3 months.  
2. Five online questionnaires: We will invite both you and your supporter to fill out online 
questionnaires today and every month for the next 3 months.  You will each earn $110 total if 
you complete all of these questionnaires. You will be paid: 
a. $10 for a 20-minute questionnaire at the beginning of the appointment today 
b. $10 for a 5-minute questionnaire at the end of the appointment today 
c. $20 for a 20-minute questionnaire in 1 month 
d. $30 for a 20-minute questionnaire in 2 months 
e. $40 for a 20-minute questionnaire in 3 months 
The possible benefits of consenting to participate are learning more about yourself or 
understanding yourself better, improving communication between you and your supporter, or 
helping other people who have been sexually assaulted by contributing to research on this topic.  
The possible risks are that you might find the questionnaires to be sensitive or upsetting. You 
might not get your preferred version of the program or get it right away. You might feel 
distressed if you or your supporter do not want to participate or use the CARE skills. It is 
possible that participating in this program could call attention to problems you are having in your 
relationship. 
This study is confidential. The information you share with us will be kept confidential and will 
not be stored with your name or contact information. We will not share your responses with your 
supporter, and we will not share your supporter’s responses with you. Only the research team 
will have access to this information. There is an important exception: if you tell us about a 
serious threat to your safety or someone else’s safety, we will need to tell someone else. 
Participation is completely voluntary (meaning it’s up to you). This study is not a part of any 
other clinical services you may be receiving and will not affect any other services you get. You 
can choose not to participate or end your participation at any time without any consequences. 
If you don’t want to participate but still want support, we will help connect you with services. 

Survivor Consent Form 
2 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
DETAILED STUDY INFORMATION 
Researchers:  
Dr. Emily Dworkin, Principal Investigator 
Dept. of Psychiatry and Behavioral Sciences, University of Washington 
206-221-6932, edworkin@uw.edu 
Dr. Michele Bedard-Gilligan, Co-Investigator 
Dept. of Psychiatry and Behavioral Sciences, University of Washington 
206-616-4215, mab29@uw.edu 
Researchers’ Statement 
We are asking you to be in a research study that is funded by the Department of Justice’s Office 
on Violence Against Women. The purpose of this statement is to give you the information you 
will need to help you decide whether to be in the study or not. Please read the form carefully. 
You may ask questions about the purpose of the research, what we would ask you to do, the 
possible risks and benefits, your rights as a volunteer, and anything else about the research or this 
form that is not clear. When we have answered all your questions, you can decide if you want to 
be in the study or not. This process is called “informed consent.”   
You may choose to review this form and make a decision about participating separately from 
your supporter, or together. You may also talk privately about your decision to participate with 
your supporter, without the researcher present, should you wish to do so. However, to 
participate, both you and the person you came to this appointment with must agree to participate.   
PURPOSE OF THE STUDY 
We are doing a study of a program that aims to help survivors and their supporters communicate 
in ways that may help survivors recover after an unwanted sexual experience. The study’s goal is 
to understand whether this program is helpful. We aim to enroll a total of 60-72 survivors and 
60-72 of their supporters in this study.  
STUDY PROCEDURES 
Participation in this voluntary study takes 3 months and involves two parts:  
(1)  Filling out 5 questionnaires 
How the questionnaires work: 
We will ask you and your supporter to both fill out a 20-minute questionnaire at the 
beginning of the appointment today, then fill out the same questionnaire again in 1, 2, and 
3 months. We will ask you to fill out a 5-minute questionnaire at the end of the 
appointment today. If your appointment today is interrupted, you will be sent this survey 
when you complete your appointment (which must occur within the next 14 days). We 
will send you a link for each questionnaire. You will have 14 days to complete each 
questionnaire.  
Payment for questionnaires: 
You will each earn $110 total if you complete all of these questionnaires. You will be 
paid: 
a. $10 for the 20-minute questionnaire at the beginning of the appointment today 
b. $10 for the 5-minute questionnaire at the end of the appointment today 
c. $20 for the 20-minute questionnaire in 1 month 

Survivor Consent Form 
3 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
d. $30 for the 20-minute questionnaire in 2 months 
e. $40 for the 20-minute questionnaire in 3 months 
You can choose to get an emailed gift card from a variety of retailers (including Amazon, 
CVS, Target, and Safeway), or get a pre-loaded Visa cash card (which you may pick up 
at Harborview or have mailed to you).  
The kinds of questions you will be asked:  
The questionnaires will ask sensitive questions about your feelings and mood, your 
opinions about your relationships, your ability to function in your life, and characteristics 
of the unwanted sexual experience.  
We will also ask you questions about your relationship with the person who came to this 
appointment with you today. Their surveys will include questions about you. To help 
make sure both of you know who we mean when we ask you questions about each other, 
we will mention their first name in your surveys, and your first name in their surveys.  
You do not have to answer any questions you do not wish to answer. You can stop filling 
out questionnaires at any time. You can choose to not fill out a questionnaire at all. Here 
are some examples of the most sensitive questions: 
In the past month, how much have you been bothered by: 
● Avoiding memories, thoughts, or feelings related to the unwanted sexual 
experience? 
● Having strong negative feelings such as fear, horror, anger, guilt, or 
shame? 
Have any of the following unwanted sexual experiences happened?  
● Someone had oral sex with me or made me have oral sex with them without 
my consent by using force, for example holding me down with their body 
weight, pinning my arms, or having a weapon. 
● A man put his penis into my vagina, or someone inserted fingers or objects 
without my consent by taking advantage of me when I was too drunk or out 
of it to stop what was happening. 
If you had to decide today whether or not you want to participate in the legal 
process for the unwanted sexual experience, what would you choose? 
Getting your contact information:  
We will ask you to give us your preferred contact information (your phone number, 
email, or social media information) so that we can contact you to send you the follow-up 
questionnaires. Your name and contact information will never be stored with the answers 
you give in the questionnaires. The information that you share is up to you, but we cannot 
send you questionnaires if we do not have contact information.  
(2)  Getting the CARE program 
What the program involves: 
This program is not therapy. There are different options for getting the program, but all of 
them involve getting information about how to communicate with each other in ways that 
support your healing. The option that you get is decided randomly (like flipping a coin).  

Survivor Consent Form 
4 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
● Option 1: You and your supporter attend a ~90 minute long CARE program 
appointment together today and a second appointment in about 2 weeks. The first 90-
minute appointment would start after your finish your questionnaires, so your entire 
appointment time today would be ~2.5 hours. After the appointment today, you will 
both be sent a workbook that goes over what you learned and gives you some 
exercises to practice your new skills. You will be asked to meet with each other 
privately to practice your skills after your appointment today. In the event that you 
are unable to complete the first CARE program appointment today, please be aware 
that this appointment must be completed within 14 days. Your second CARE 
program appointment must be completed within 30 days. 
● Option 2: Your supporter attends a ~90 minute long CARE program appointment 
alone today and a second appointment in about 2 weeks. After the appointment today, 
you would both still be sent a workbook that goes over what the supporter learned 
and gives you some exercises to practice your new skills. You would be asked to 
meet with each other privately after your appointment so that your supporter can 
teach you the skills that they learned in the program. With this option, you would still 
get the benefits of the program without having to be in the appointments. We are 
testing out this option because we know that attending an appointment can be hard 
when someone is going through a crisis, and having some people get the program in 
this way would tell us whether the program works just as well without the survivor 
there.  
● Option 3: You choose which version of the program you want (with your supporter 
or your supporter alone), and you get that version in 3 months.  
We are unable to make changes to your version of the program after it is assigned. 
If you get the program where you attend sessions together, both you and your supporter 
will need to be present for sessions to receive the program. If you get the version of the 
program where your supporter attends sessions alone, you will only be able to receive the 
program if they attend the sessions.  
Audiorecording the program appointments: 
We will audiorecord the appointments so that we can make sure that the clinician is 
covering all the topics they need to cover. If you give us any feedback about the program 
during the appointments, we will use the recordings to type out and save the feedback 
without your name attached. We will not use this recording for any other purpose and 
will destroy it as soon as we have checked it. 
Payment for the program appointment: 
Neither you nor your supporter will be paid for participating in the program: you will 
only be paid for questionnaires. You can still get paid for filling out the questionnaires 
even if you do not participate in the program.  
Participation in this research is voluntary. That means it’s your decision. 
● To enroll in the study, both you and your supporter must both consent to 
participate. However, you should each make your own decision about whether you want 
to participate. You may also tell us that you no longer want both you and your supporter 
to participate, in which case we will withdraw both of you from the study. However, you 
cannot replace your supporter with a different person. 

Survivor Consent Form 
5 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
● It’s up to you whether you complete the questionnaires. You may skip over any 
questions you do not want to answer or decide to stop participating at any time. You can 
still receive the program even if you don’t fill out the questionnaires. If one person drops 
out after enrolling, the other person can still fill out questionnaires. 
● It’s up to you whether you complete the program appointments. You can end your 
participation in the program at any time- even during an appointment. Even if you or your 
supporter choose to opt out of program appointments, you can still do questionnaires and 
be paid.  
● This study and the program we are studying are not part of your clinical services. 
Deciding not to participate will not affect any services you get at any other site serving 
survivors of unwanted sexual experiences (e.g., Harborview). Your decision to 
participate, and everything you tell us today, will not be recorded anywhere in your 
clinical files.    
RISKS, STRESS, OR DISCOMFORT 
There might be risks associated with being in this study.  
● The main risk of this study is that we will be asking you sensitive and private questions. 
These questions may make you feel uncomfortable or may feel intrusive.  
● You might feel uncomfortable about your supporter being asked questions about their 
relationship with you and their experiences supporting you. 
● If your supporter does not attend program sessions, you will not be able to continue with 
the program alone or replace them with another supporter.  
● It is possible that participating in this program could call attention to problems you are 
having in your relationship. 
● It is possible that you might not get your preferred version of the program, which could 
be disappointing or distressing.  
● It is possible that you might be chosen to get the program in 3 months. If you would 
prefer to get the program right away, waiting to get the program might be disappointing 
or distressing. It is possible that problems could emerge within the 3 months that might 
affect whether this program is right for you; if this happens, we might need to refer you to 
other services instead of continuing with the program.  
● Although this program is based on research about what is helpful, some people may not 
find it helpful.  
● You might feel distressed if you want to participate and/or use the CARE skills and your 
supporter does not, or if your supporter wants to participate and/or use the CARE skills 
and you do not. 
● It is possible that participating in this program could call attention to problems in your 
relationship. It is possible that this could be distressing or affect your relationship.  
● If someone else has access to the account or device where you receive links to surveys for 
this study, and unintentionally or intentionally accesses that account or device while you 
are actively taking a survey (before you finish the last question and submit your 
responses), they could see your survey responses. To prevent this, it is important that you 

Survivor Consent Form 
6 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
receive links at a private account, complete all surveys on a private device with security 
features enabled, and submit your survey as soon as possible.  
If you feel upset, or if you have any questions or need assistance, you can tell the clinician, or 
you can contact any of the study personnel listed above.   
 
ALTERNATIVES TO TAKING PART IN THIS STUDY 
If you choose not to participate in this study but still want resources to help you cope, we can 
provide you with a list of information and referrals located within the community, and help 
connect you with services if you wish. 
BENEFITS OF THE STUDY 
You might not experience any direct benefits from participating in this study. Here are some 
possible benefits: 
● You might learn more about yourself, your experience with unwanted sexual contact, 
and your relationships as you fill out the questionnaire, which could be helpful.  
● Your supporter might learn new ways to support you by being a part of this program, and 
you and your supporter might learn more helpful ways to communicate with each other 
and work together to support your recovery.  
● Participating in this study could help people who have been sexually assaulted. To learn 
how to help survivors of unwanted sexual experiences, we need to do studies to see 
what’s helpful. This is one of those studies. If we learn that this program is helpful, we 
will be able to make it available to other people who have been sexually assaulted.  
● Participating in this study is a way to support research on the topic of sexual assault. 
CONFIDENTIALITY OF RESEARCH INFORMATION 
Any identifiable information collected about you will be used only for research and statistical 
purposes. We will use the information gathered in this study in two main ways: 
● We will create research reports and presentations about this study that summarize its 
findings without singling out any one participant. Your name and identifying information 
will not be included in any research reports or presentations of this research. 
● A file containing answers to questionnaires from everyone who participates will be given 
to the National Archive of Criminal Justice Data so it can be shared with other 
researchers doing similar work at other locations. Everyone’s answers will be labeled 
with an ID number. The file will be checked to make sure that there is nothing in it that 
could tell anyone who you are. There will be no names, contact information, or any other 
personally-identifying information in the file.  
Everything you tell us will be confidential. We will not share your responses with your 
supporter, and we will not share your supporter’s responses with you. We have taken steps to 
protect your confidentiality.   
● The questionnaires will be completed using a secure server, which provides the highest 
available level of protection for your confidentiality.  
● All of your questionnaire responses will be labeled with an ID number, rather than your 
name, the name of the person participating in this study with you, or any other 

Survivor Consent Form 
7 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
information that would tell people who you are. Only the research team will know your 
ID number. That way, no one will be able to figure out your identity or the identity of the 
person participating in this study with you, even if they looked at the answers to your 
questionnaires.  
● We will put your ID number, name, and contact information in a special secured 
computer file. This file will be separate from all other information you give us as part of 
the study. The research team are the only ones who will have access to this file, and we 
will not share it with others. We will only use this file to contact you to complete the 
study, pay you for your participation, and find your ID number. We will retain your name 
and contact information until the end of the record retention period required by state 
and/or federal law.  
● We have obtained a Privacy Certificate from the National Institute of Justice. This helps 
us protect your privacy. The Certificate means that we do not have to give out identifying 
information about you even if we are asked to by a court of law. We will use the 
Certificate to resist any demands for identifying information.  We can’t use the 
Certificate to withhold your research information if you give your written consent to give 
it to an insurer, employer, or other person. Also, you can share information about yourself 
or your part in this research if you wish. The Certificate expires when the funding for this 
study ends.  Currently this is 10/31/24.  Any data collected after expiration is not 
protected as described above.  Data collected prior to expiration will continue to be 
protected even after the expiration date.   
We also ask you to take some steps to protect your own and each others’ confidentiality. 
• To make sure that no one can see your survey responses while you are in the middle of 
taking a survey, we ask you to make sure that no one else has access to the phone, laptop, 
or email accounts where you receive your survey links. You can do this by only asking us 
to send your survey links to an account or device that no one other than you has access to, 
and that you submit your surveys as soon as possible.    
• It is important to remember that the first name of the person you are participating in this 
study with will show up in the questions we ask you, and your first name will show up in 
their questions. Because of this, we ask you to help protect each others’ confidentiality by 
not sharing the link to the questionnaire with anyone else, and filling out the 
questionnaire on a private, secure device. 
● We encourage you to ensure that you are attending this session from a private location, 
and make sure that others cannot hear or see what’s happening.  
● We encourage you to check in with each other if there is anything that you would prefer 
the other person not share in this appointment. If you would like to do this, we will put 
you into a Zoom breakout room before we begin.  
However, there are some important exceptions to confidentiality: 
● The confidentiality of the data cannot be guaranteed if you report future criminal intent.  
● If we learn that you intend to harm yourself or others, or that anyone is at imminent risk 
of harm, we must report that to the authorities.  
● If you tell us about child/elder abuse, we are not allowed to report that unless you give us 
permission. We will give you the option of giving us permission but it will be up to you. 

Survivor Consent Form 
8 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
● Government or university staff sometimes review studies such as this one to make sure 
they are being done safely and legally. If a review of this study takes place, your records 
may be examined. The reviewers will protect your privacy. The study records will not be 
used to put you at legal risk of harm. 
INFORMATION FOR ADOLESCENTS 
You do not need permission from a parent or guardian to be in this study. This is because, in 
Washington State, teens age 13-17 are allowed to seek help for mental health concerns without 
parental consent.  
If you tell us about past abuse, we will not tell anyone without your permission. Instead, we 
will give you the option of talking with us about the pros and cons of contacting the authorities, 
and different options for doing so. We will only tell the authorities if you fill out a form saying 
it’s okay. 
FUTURE USE OF DATA 
Data identified only by your ID number (not your name, contact information, or any other 
information that may identify you) may be shared with other researchers doing similar work on 
other campuses, be combined with data from other campuses in some research reports, and/or 
may be used to develop procedures used in future studies. These data will be retained 
indefinitely, identified only by the ID number.  
OTHER INFORMATION 
You may refuse to participate or withdraw from this study at any time without penalty or 
loss of benefits to which you are otherwise entitled. 
If at any point we determine that you are not eligible for this study, if your condition deteriorates, 
or if it becomes known that you require a higher level or different type of care, we will withdraw 
you from the study and not invite you to complete any remaining surveys or sessions. We will 
provide you referrals for services if this happens. 
You should not incur any expenses from your participation in this research. You are free to 
participate in other programs such as support groups, treatment, therapy, etc. while involved in 
the study.   
If you become concerned about problems you’re experiencing related to the unwanted sexual 
experience, or if you experience discomfort as a result of your participation, you can contact one 
of the researchers listed above to discuss your concerns. We will be happy to provide referrals 
for services. You can contact study personnel by phone or email during regular business hours.  
RESEARCH-RELATED INJURY 
If you think you have been harmed from this research, contact one of the study investigators 
right away. They will treat you or refer you for treatment. You may also reach out to them if you 
have questions about the study or your rights as a participant. Their contact information is at the 
beginning of this form.  
Subject’s Statement 
This study has been explained to me.  I volunteer to take part in this research.  I have had a 
chance to ask questions and discuss this decision with my supporter, if I wish to do so.   
If I have questions later about the research, or if I have been harmed by participating in this 
study, I can contact one of the researchers listed on the first page of this consent form.  If I have 

Survivor Consent Form 
9 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
questions about my rights as a research subject, I can call the Human Subjects Division at (206) 
543-0098 or call collect at (206) 221-5940. 
[  ] I accept. I want to participate in this study.  
[  ] I do not accept.  
 

 
1 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
UNIVERSITY OF WASHINGTON 
Supporter Consent Form (Stage 2) 
KEY STUDY INFORMATION 
We are asking whether you want to consent to participate in a research study. The research study aims to 
understand whether a program is helpful to survivors and their supporters. Participation involves:   
1. Two ~90 minute CARE telehealth program appointments that focus on how you and the survivor 
can communicate in ways that may help them recover. You will be randomly selected to get the program 
in one of three ways: 
a. Option 1: You and the survivor attend the program appointments together starting today. The 
first 90-minute appointment would start after your finish your questionnaires, so your entire 
appointment time today would be ~2.5 hours. You will both get a workbook to work on together 
after your first appointment. 
b. Option 2: You attend the program appointments alone starting today.  The first 90-minute 
appointment would start after your finish your questionnaires, so your entire appointment time 
today would be ~2.5 hours. You will be asked to meet with the survivor privately after your first 
appointment and teach them about what you learned using a workbook that we will give both of 
you.  
c. Option 3: The survivor chooses which version of the program they want, and you get it in 3 
months.  
2. Five online questionnaires: We will invite both you and the survivor to fill out online questionnaires 
today and every month for the next 3 months.  You will each earn $110 total if you complete all of 
these questionnaires. You will be paid: 
a. $10 for a 20-minute questionnaire at the beginning of the appointment today 
b. $10 for a 5-minute questionnaire at the end of the appointment today 
c. $20 for a 20-minute questionnaire in 1 month 
d. $30 for a 20-minute questionnaire in 2 months 
e. $40 for a 20-minute questionnaire in 3 months 
The possible benefits of consenting to participate are learning more about yourself or understanding yourself 
better, helping the survivor in your life, or helping people who have been sexually assaulted by contributing to 
research on this topic.  
The possible risks are that you might find the questionnaires to be sensitive or upsetting. You might not get 
your preferred version of the program or get it right away. and being in the program might make some people 
feel upset. You might feel distressed if you or the survivor do not want to participate or use the CARE skills. It 
is possible that participating in this program could call attention to problems you are having in your 
relationship. 
This study is confidential. The information you share with us will be kept confidential and will not be stored 
with your name or contact information. We will not share your responses with the survivor, and we will not 
share the survivor’s responses with you. Only the research team will have access to the information you share 
with us. There is an important exception: if you tell us about a serious threat to your safety or someone else’s 
safety, we will need to tell someone else. 
Participation is completely voluntary (meaning it’s up to you). This study is not a part of any other clinical 
services you may be receiving and will not affect any other services you get. You can choose not to participate 
or end your participation at any time without any consequences. 
If you don’t want to participate but still want support, we will help connect you with services. 

 
2 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
DETAILED STUDY INFORMATION 
Researchers:  
Dr. Emily Dworkin, Principal Investigator 
Dept. of Psychiatry and Behavioral Sciences, University of Washington 
206-221-6932, edworkin@uw.edu 
Dr. Michele Bedard-Gilligan, Co-Investigator 
Dept. of Psychiatry and Behavioral Sciences, University of Washington 
206-616-4215, mab29@uw.edu 
Researchers’ Statement 
We are asking you to be in a research study that is funded by the Department of Justice’s Office on Violence 
Against Women. The purpose of this statement is to give you the information you will need to help you decide 
whether to be in the study or not. Please read the form carefully. You may ask questions about the purpose of 
the research, what we would ask you to do, the possible risks and benefits, your rights as a volunteer, and 
anything else about the research or this form that is not clear. When we have answered all your questions, you 
can decide if you want to be in the study or not. This process is called “informed consent.”   
You may choose to review this form and make a decision about participating separately from the survivor, or 
together. You may also talk privately about your decision to participate with the survivor, without the researcher 
present, should you wish to do so. However, to participate, both you and the survivor must agree to participate.   
PURPOSE OF THE STUDY 
We are doing a study of a program that aims to help survivors and their supporters communicate in ways that 
may help survivors recover after an unwanted sexual experience. The study’s goal is to understand whether this 
program is helpful. We aim to enroll a total of 60-72 survivors and 60-72 of their supporters in this study.  
STUDY PROCEDURES 
Participation in this voluntary study takes 3 months and involves two parts:  
(1)  Filling out 5 questionnaires 
How the questionnaires work: 
We will ask you and the survivor to both fill out a 20-minute questionnaire at the beginning of the 
appointment today, then fill out the same questionnaire again in 1, 2, and 3 months. We will ask you to 
fill out a 5-minute questionnaire at the end of the appointment today. If your appointment today is 
interrupted, you will be sent this survey when you complete your appointment (which must occur within 
the next 14 days). We will send you a link for each questionnaire. You will have 14 days to complete 
each questionnaire. 
Payment for questionnaires: 
You will each earn $110 total if you complete all of these questionnaires. You will be paid: 
a. $10 for the 20-minute questionnaire at the beginning of the appointment today 
b. $10 for the 5-minute questionnaire at the end of the appointment today 
c. $20 for the 20-minute questionnaire in 1 month 
d. $30 for the 20-minute questionnaire in 2 months 
e. $40 for the 20-minute questionnaire in 3 months 
You can choose to get an emailed gift card from a variety of retailers (including Amazon, CVS, Target, 
and Safeway), or get a pre-loaded Visa cash card (which you may pick up at Harborview or have mailed 
to you).  

 
3 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
The kinds of questions you will be asked:  
The questionnaires will ask sensitive questions about what it has been like for you to support the 
survivor, what you know about how to support survivors, and your personal demographic 
characteristics.  
We will also ask you questions about your relationship with the survivor. Their surveys will include 
questions about you. To help make sure both of you know who we mean when we ask you questions 
about each other, we will mention their first name in your surveys, and your first name in their surveys.  
You do not have to answer any questions you do not wish to answer. You can stop filling out 
questionnaires at any time. You can choose to not fill out a questionnaire at all. Here are some examples 
of the most sensitive questions: 
Indicate how much you agree or disagree with the following statements about what it’s been like to 
try and help the survivor. 
● I feel preoccupied with the details of the assault. 
● I feel disturbed dealing with his/her assault. 
How often did you respond in each of the following ways? 
● Told them that they were irresponsible or not cautious enough. 
● Got so upset that you needed reassurance from them. 
Getting your contact information:  
We will ask you to give us your preferred contact information (your phone number, email, or social 
media information) so that we can contact you to send you the follow-up questionnaires. Your name and 
contact information will never be stored with the answers you give in the questionnaires. The 
information that you share is up to you, but we cannot send you questionnaires if we do not have contact 
information.  
(2)  Getting the CARE program 
What the program involves: 
This program is not therapy. There are different options for getting the program, but all of them involve 
getting information about how to communicate with each other in ways that support the survivor’s 
healing. The option that you get is decided randomly (like flipping a coin).  
● Option 1: You and the survivor attend a ~90 minute long CARE program appointment together 
today and a second appointment in 2 weeks. The 90-minute appointment would start after your finish 
your questionnaires, so your entire appointment time today would be ~2.5 hours. After the 
appointment today, you will both be sent a workbook that goes over what you learned and gives you 
some exercises to practice your new skills. You will be asked to meet with each other privately to 
practice your skills after your appointment today. In the event that you are unable to complete the 
first CARE program appointment today, please be aware that this appointment must be completed 
within 14 days. Your second CARE program appointment must be completed within 30 days. 
● Option 2: You attend a ~90 minute long CARE program appointment alone today and a second 
appointment in 2 weeks. After the appointment today, you would both still be sent a workbook that 
goes over what the supporter learned and gives you some exercises to practice your new skills. You 
would be asked to meet with each other privately after your appointment to teach the survivor the 
skills that you learned in the program. This way, the survivor still get the benefits of the program 
without having to be in the appointment. We are testing out this option because we know that 
attending an appointment can be hard when someone is going through a crisis, and having some 
people get the program in this way would tell us whether the program works just as well without the 
survivor there. In the event that you are unable to complete the first CARE program appointment 

 
4 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
today, please be aware that this appointment must be completed within 14 days. Your second CARE 
program appointment must be completed within 30 days. 
● Option 3: The survivor chooses which version of the program they want, and you get that version in 
3 months.  
We are unable to make changes to your version of the program after it is assigned. If you get the 
program where you attend sessions together, both you and the survivor will need to be present for 
sessions to receive the program. If you get the version of the program where you attend sessions alone, 
the survivor will only be able to receive the program if you attend the sessions.  
Audiorecording the program appointments: 
We will audiorecord the appointments so that we can make sure that the clinician is covering all the 
topics they need to cover. If you give us any feedback about the program during the appointments, we 
will use the recordings to type out and save the feedback without your name attached. We will not use 
this recording for any other purpose and will destroy it as soon as we have checked it. 
Payment for the program appointment: 
Neither you nor the survivor will be paid for participating in the program: you will only be paid for 
questionnaires. You can still get paid for filling out the questionnaires even if you do not participate in 
the program.  
Participation in this research is voluntary. That means it’s your decision. 
● To enroll in the study, both you and the survivor must both consent to participate. However, you 
should each make your own decision about whether you want to participate.  The survivor also has the 
right to tell us that they no longer want both themselves and you to participate, in which case we will 
withdraw both of you from the study. However, the survivor cannot replace you with a different 
supporter. 
● It’s up to you whether you complete the questionnaires. You may skip over any questions you do not 
want to answer or decide to stop participating at any time. You can still receive the program even if you 
don’t fill out the questionnaires. If one person drops out after enrolling, the other person can still fill out 
questionnaires.  
● It’s up to you whether you complete the program appointments. You can end your participation in 
the program at any time- even during an appointment. Even if you or the survivor choose to opt out of 
program appointments, you can still do questionnaires and be paid.  
● This study and the program we are studying are not part of your clinical services. Deciding not to 
participate will not affect any services you get at any other site serving survivors of unwanted sexual 
experiences (e.g., Harborview). Your decision to participate, and everything you tell us today, will not 
be recorded anywhere in any clinical files.    
RISKS, STRESS, OR DISCOMFORT 
There might be risks associated with being in this study.  
● The main risk of this study is that we will be asking you sensitive and private questions. These questions 
may make you feel uncomfortable or may feel intrusive.  
● You might feel uncomfortable about the survivor being asked questions about their relationship with you 
and their experiences being supported by you. 
● If you do not attend program sessions, the survivor will not be able to continue with the program alone 
or replace you with another supporter.  

 
5 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
● It is possible that you might not get your preferred version of the program, which could be disappointing 
or distressing.  
● It is possible that you might be chosen to get the program in 3 months. If you would prefer to get the 
program right away, waiting to get the program might be disappointing or distressing.  
● Being in the program may remind you of problems you’re having and could make you feel upset.  
● Although this program is based on research about what is helpful, some people may not find it helpful.  
● You might feel distressed if you want to participate and/or use the CARE skills and the survivor does 
not, or if the survivor wants to participate and/or use the CARE skills and you do not. 
● It is possible that participating in this program could call attention to problems you are having in your 
relationship. It is possible that this could be distressing or affect your relationship.  
● If someone else has access to the account or device where you receive links to surveys for this study, 
and unintentionally or intentionally accesses that account or device while you are actively taking a 
survey (before you finish the last question and submit your responses), they could see your survey 
responses. To prevent this, it is important that you receive links at a private account, complete all 
surveys on a private device with security features enabled, and submit your survey as soon as possible.  
If you feel upset, or if you have any questions or need assistance, you can tell the clinician, or you can contact 
any of the study personnel listed above.   
ALTERNATIVES TO TAKING PART IN THIS STUDY 
If you choose not to participate in this study but still want resources to help you cope, we can provide you with 
a list of information and referrals located within the community, and help connect you with services if you wish. 
BENEFITS OF THE STUDY 
You might not experience any direct benefits from participating in this study. Here are some possible 
benefits: 
● You might learn more about yourself, your experience providing support, and your relationships as you 
go through this study, which could be helpful.  
● You might learn new ways to support the survivor by being a part of this program, and you and the 
survivor might learn more helpful ways to communicate with each other and work together to support 
their recovery.  
● Participating in this study could help people who have been sexually assaulted. To learn how to help 
survivors of unwanted sexual experiences, we need to do studies to see what’s helpful. This is one of 
those studies. If we learn that this program is helpful, we will be able to make it available to other 
people who have been sexually assaulted.  
● Participating in this study is a way to support research on the topic of unwanted sexual experiences. 
CONFIDENTIALITY OF RESEARCH INFORMATION 
Any identifiable information collected about you will be used only for research and statistical purposes. We will 
use the information gathered in this study in two main ways: 
● We will create research reports and presentations about this study that summarize its findings without 
singling out any one participant. Your name and identifying information will not be included in any 
research reports or presentations of this research. 
● A file containing answers to questionnaires from everyone who participates will be given to the National 
Archive of Criminal Justice Data so it can be shared with other researchers doing similar work at other 

 
6 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
locations. Everyone’s answers will be labeled with an ID number. The file will be checked to make sure 
that there is nothing in it that could tell anyone who you are. There will be no names, contact 
information, or any other personally-identifying information in the file.  
Everything you tell us will be confidential. We will not share your responses with the survivor, and we will 
not share the survivor’s responses with you. We have taken steps to protect your confidentiality.   
● The questionnaires will be completed using a secure server, which provides the highest available level of 
protection for your confidentiality.  
● All of your questionnaire responses will be labeled with an ID number, rather than your name, the name 
of the person participating in this study with you, or any other information that would tell people who 
you are. Only the research team will know your ID number. That way, no one will be able to figure out 
your identity or the identity of the person participating in this study with you, even if they looked at the 
answers to your questionnaires.  
● We will put your ID number, name, and contact information in a special secured computer file. This file 
will be separate from all other information you give us as part of the study. The research team are the 
only ones who will have access to this file, and we will not share it with others. We will only use this 
file to contact you to complete the study, pay you for your participation, and find your ID number. We 
will retain your name and contact information until the end of the record retention period required by 
state and/or federal law.  
● We have obtained a Privacy Certificate from the National Institute of Justice. This helps us protect your 
privacy. The Certificate means that we do not have to give out identifying information about you even if 
we are asked to by a court of law. We will use the Certificate to resist any demands for identifying 
information.  We can’t use the Certificate to withhold your research information if you give your written 
consent to give it to an insurer, employer, or other person. Also, you can share information about 
yourself or your part in this research if you wish. The Certificate expires when the funding for this study 
ends.  Currently this is 10/31/24.  Any data collected after expiration is not protected as described above.  
Data collected prior to expiration will continue to be protected even after the expiration date.   
We also ask you to take some steps to protect your own and each others’ confidentiality. 
● To make sure that no one can see your survey responses while you are in the middle of taking a survey, 
we ask you to make sure that no one else has access to the phone, laptop, or email accounts where you 
receive your survey links. You can do this by only asking us to send your survey links to an account or 
device that no one other than you has access to, and that you submit your surveys as soon as possible.    
● It is important to remember that the first name of the person you are participating in this study with will 
show up in the questions we ask you, and your first name will show up in their questions. Because of 
this, we ask you to help protect each others’ confidentiality by not sharing the link to the questionnaire 
with anyone else, and filling out the questionnaire on a private, secure device.  
● We encourage you to ensure that you are attending this session from a private location, and make sure 
that others cannot hear or see what’s happening.  
● We encourage you to check in with each other if there is anything that you would prefer the other person 
not share in this appointment. If you would like to do this, we will put you into a Zoom breakout room 
before we begin.  
However, there are some important exceptions to confidentiality: 
● The confidentiality of the data cannot be guaranteed if you report future criminal intent.  
● If we learn that you intend to harm yourself or others, or that anyone is at imminent risk of harm, we 
must report that to the authorities.  

 
7 
 
Please review this form before your appointment. You will have a chance to discuss this form with a study staff 
member and then sign it during your appointment. You don’t need to sign it in advance.  
● If you tell us about child/elder abuse, we are not allowed to report that unless you give us permission. 
We will give you the option of giving us permission but it will be up to you. 
● Government or university staff sometimes review studies such as this one to make sure they are being 
done safely and legally. If a review of this study takes place, your records may be examined. The 
reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm. 
INFORMATION FOR ADOLESCENTS 
You do not need permission from a parent or guardian to be in this study. This is because, in Washington 
State, teens age 13-17 are allowed to seek help for mental health concerns without parental consent.  
If you tell us about past abuse, we will not tell anyone without your permission. Instead, we will give you 
the option of talking with us about the pros and cons of contacting the authorities, and different options for 
doing so. We will only tell the authorities if you fill out a form saying it’s okay. 
FUTURE USE OF DATA 
Data identified only by your ID number (not your name, contact information, or any other information that may 
identify you) may be shared with other researchers doing similar work on other campuses, be combined with 
data from other campuses in some research reports, and/or may be used to develop procedures used in future 
studies. These data will be retained indefinitely, identified only by the ID number.  
OTHER INFORMATION 
You may refuse to participate or withdraw from this study at any time without penalty or loss of benefits 
to which you are otherwise entitled. 
If at any point we determine that you are not eligible for this study, if your condition deteriorates, or if it 
becomes known that you require a higher level or different type of care, we will withdraw you from the study 
and not invite you to complete any remaining surveys or sessions. We will provide you referrals for services if 
this happens. 
You should not incur any expenses from your participation in this research. You are free to participate in other 
programs such as support groups, treatment, therapy, etc. while involved in the study.   
If you become concerned about problems you’re experiencing related to supporting the survivor, or if you 
experience discomfort as a result of your participation, you can contact one of the researchers listed above to 
discuss your concerns. We will be happy to provide referrals for services. You can contact study personnel by 
phone or email during regular business hours.  
RESEARCH-RELATED INJURY 
If you think you have been harmed from this research, contact one of the study investigators right away. They 
will treat you or refer you for treatment. You may also reach out to them if you have questions about the study 
or your rights as a participant. Their contact information is at the beginning of this form.  
Subject’s Statement 
This study has been explained to me.  I volunteer to take part in this research.  I have had a chance to ask 
questions and discuss this decision with the survivor, if I wish to do so.   
If I have questions later about the research, or if I have been harmed by participating in this study, I can contact 
one of the researchers listed on the first page of this consent form.  If I have questions about my rights as a 
research subject, I can call the Human Subjects Division at (206) 543-0098 or call collect at (206) 221-5940. 
[  ] I accept. I want to participate in this study.  
[  ] I do not accept.