Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors (CARE)

Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention

Communication and Recovery Enhancement (CARE) is a 2-session early intervention for survivors of recent sexual assault and their supporters that aims to improve supporters' ability to respond effectively. The goal of this pilot trial is to understand the acceptability and preliminary efficacy of two versions of CARE: a version in which survivors and supporters attend both sessions together (dyadic CARE) and a version in which supporters attend sessions alone (supporter-only CARE). Survivors aged 14+ with elevated posttraumatic stress symptoms will enroll with a supporter of their choosing. Dyads will be randomized to dyadic CARE, supporter-only CARE, or waitlist control, and will complete self-report assessments at baseline, post-session-1, and follow-ups (1, 2, and 3 months post-baseline). Results will be used to inform future changes to CARE and determine whether a fully-powered randomized controlled trial is warranted.

Study Overview

• Status: Completed
• Conditions: Stress; Stress Disorders, Post-Traumatic; Sexual Violence; Sexual Assault; Help-Seeking Behavior; Social Interaction; Helping Behavior; Relationship, Social
• Intervention / Treatment: Behavioral: Dyadic CARE; Behavioral: Supporter-Only CARE

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195-7238
      • University of Washington School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dyadic CARE; Participants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.	Behavioral: 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.
Active Comparator: Supporter-Only CARE; Participants will receive supporter-only CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report)	Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction	1 month
Supporter Satisfaction With Intervention at 1 Month Post-baseline (Self Report)	Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction	1 month
Change in Survivor Knowledge at 1 Month Post-baseline (Self Report)	Sum score on a knowledge questionnaire reflecting CARE concepts, completed by the survivor. Range: 8 to 40; higher scores indicate more knowledge about CARE concepts.	Baseline, 1 month
Change in Supporter Knowledge at 1 Month Post-baseline (Self Report)	Sum score on a knowledge questionnaire reflecting CARE concepts, completed by the supporter. Range: 9 to 45; higher scores indicate more knowledge about CARE concepts.	Baseline, 1 month
Change in Survivor Confusion About Help-seeking Behavior at 1 Month Post-baseline (Self Report)	Sum score on 4-item measure created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater confusion.	Baseline, 1 month
Change in Supporter Confusion About Helping Behavior at 1 Month Post-baseline (Self Report)	Sum score on the Confusion subscale of the Impact on Friends scale, completed by supporter. Range: 6 to 30; higher scores indicate greater confusion about helping behavior.	Baseline, 1 month
Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Self Report)	Single item representing frequency of disclosures to supporter in past month, completed by survivor, adapted from the Early Intervention Clinic Disclosure scale. Survivor will input a numerical response representing number of disclosures. Higher scores indicate more frequent disclosure.	1 month
Supporter Overt Hostile Reactions to Disclosure at 1 Month Post-baseline (Informant Report)	Sum score on Turning Against subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions in past month. Range: 0 to 24; higher scores indicate more frequent hostile negative reactions.	1 month
Supporter Subtly Unsupportive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)	Sum score on Unsupportive Acknowledgment subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions in past month. Range: 0 to 24; higher scores indicate more frequent subtly unsupportive reactions.	1 month
Change in Supporter Responsiveness at 1 Month Post-baseline (Informant Report)	Sum score on the Responsiveness subscale of the Perceived Responsiveness and Insensitivity scale, completed by survivor in reference to past month. Range: 0 to 40; higher scores indicate greater responsiveness.	Baseline & 1 month
Change in Survivor PTSD Symptom Severity at 3 Months Post-baseline (Self Report)	Sum score on PTSD Checklist-5 (PCL-5), completed by survivor in reference to past month. Range: 0-80; higher scores indicate greater severity of PTSD symptoms.	Baseline, 3 months
Survivor Provisional PTSD Diagnostic Status at 3 Months Post-baseline (Self Report)	Provisional PTSD diagnostic status based on PTSD Checklist-5 (PCL-5), completed by survivor in reference to past month. Survivors will be considered to have a provisional diagnosis if the following items are rated as 2 = "Moderately" or higher: one Criterion B item (questions 1-5), one Criterion C item (questions 6-7), two Criterion D items (questions 8-14), and two Criterion E items (questions 15-20).	3 months
Change in Survivor Stress at 3 Months Post-baseline (Self Report)	Sum score on the Stress subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by survivor in reference to past week. Range: 0 to 21; higher scores indicate greater stress.	Baseline, 3 months
Change in Supporter Stress at 3 Months Post-baseline (Self Report)	Sum score on the Stress subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by supporter in reference to past week. Range: 0 to 21; higher scores indicate greater stress.	Baseline, 3 months
Change in Survivor Perceived Relationship Quality at 3 Months Post-baseline (Self Report)	Sum score on the Relationship Assessment Scale, completed by survivor. Range: 7 to 35; higher scores indicate greater relationship quality.	Baseline, 3 months
Change in Supporter Perceived Relationship Quality at 3 Months Post-baseline (Self Report)	Sum score on the Relationship Assessment Scale, completed by supporter. Range: 7 to 35; higher scores indicate greater relationship quality.	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report)	Sum score score on measure created for this study, completed by survivor. Range: 0 to 10; higher scores indicate greater willingness.	1 month
Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report)	Mean score on measure created for this study, completed by survivor. Range: 0 to 1; higher scores indicate greater participation.	1 month
Change in Survivor Depression at 3 Months Post-baseline (Self Report)	Sum score on the Depression subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by survivor in reference to past week. Range: 0 to 21; higher scores indicate greater depression.	Baseline, 3 months
Change in Supporter Depression at 3 Months Post-baseline (Self Report)	Sum score on the Depression subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by supporter in reference to past week. Range: 0 to 21; higher scores indicate greater depression.	Baseline, 3 months
Change in Survivor Anxiety at 3 Months Post-baseline (Self Report)	Sum score on the Anxiety subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by survivor in reference to past week. Range: 0 to 21; higher scores indicate greater anxiety.	Baseline, 3 months
Change in Supporter Anxiety at 3 Months Post-baseline (Self Report)	Sum score on the Anxiety subscale of the Depression and Anxiety Stress Scales (DASS-21), completed by supporter in reference to past week. Range: 0 to 21; higher scores indicate greater anxiety.	Baseline, 3 months
Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report)	Sum score on Work/School/Responsibility Impairment subscale of the Behavioral Activation for Depression Scale (BADS), completed by survivor in reference to past week. Range: 0 to 30; higher scores indicate more impairment.	Baseline, 3 months
Change in Survivor Social Impairment at 3 Months Post-baseline (Self Report)	Sum score on Social Impairment subscale of the Behavioral Activation for Depression Scale (BADS), completed by survivor in reference to past week. Range: 0 to 30; higher scores indicate more impairment.	Baseline, 3 months
Change in Survivor Flourishing at 3 Months Post-baseline (Self Report)	Sum score on Flourishing Index Measure, completed by survivor. Range: 0 to 120; higher scores indicate more flourishing.	Baseline, 3 months
Change in Supporter Flourishing at 3 Months Post-baseline (Self Report)	Sum score on Flourishing Index Measure, completed by supporter. Range: 0 to 120; higher scores indicate more flourishing.	Baseline, 3 months
Survivor Distress Associated With Supporter Negative Reactions at 1 Month Post-baseline (Self Report)	Mean score on ratings of distress associated endorsed items on Negative Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions to survivor in past month. Range: 0 to 3; higher scores indicate more distress.	1 month
Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)	Sum score on Positive Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions in past month. Range: 0 to 16; higher scores indicate more frequent positive reactions.	1 month
Change in Survivor Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)	Number of typical drinks per week in past month reported by survivor on the Daily Drinking Questionnaire	Baseline, 3 months
Change in Survivor Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)	Number of typical drinking days per week in past month reported by survivor on the Daily Drinking Questionnaire. Range: 0 to 7.	Baseline, 3 months
Change in Survivor Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)	Number of typical drinking hours per week in past month reported by survivor on the Daily Drinking Questionnaire.	Baseline, 3 months
Supporter Perceived Helping Ineffectiveness at 1 Month Post-baseline (Self Report)	Sum score on the Confusion subscale of the Impact on Friends measure, completed by supporter in reference to the past month. Range: 6 to 30; higher scores indicate greater perceived ineffectiveness.	1 month
Supporter Distress in Helping at 1 Month Post-baseline (Self Report)	Sum score on the Emotional Distress subscale of the Impact on Friends measure, completed by supporter in reference to the past month. Range: 24 to 120; higher scores indicate greater distress.	1 month
Supporter Accommodation of Survivor PTSD Symptoms at 1 Month Post-baseline (Self Report)	Sum score on the Significant Others' Responses to Trauma Scale (SORTS), completed by supporter in reference to the past month. Range: 0 to 112; higher scores indicate greater accommodation.	1 month
Change in Survivor Cannabis Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of cannabis use in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)	Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of non-prescription opioid use in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)	Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of methamphetamine use in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Cigarette Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of cigarette use in past 2 weeks, as reported by survivor. Range: 0 to 14.	Baseline, 3 months
Change in Survivor Cigarette Use Quantity at 3 Months Post-baseline (Self Report)	Number of cigarettes smoked in a typical day in past 2 weeks, as reported by survivor.	Baseline, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Informant Report)	Single item representing frequency of survivor's disclosures to supporter in past month, completed by supporter, adapted from the Early Intervention Clinic Disclosure Scale. Participants were instructed to enter a numerical value corresponding to number of disclosures. Higher scores indicate more frequent disclosure.	1 month
Supporter Negative Reactions to Disclosure at 1 Month Post-baseline (Self Report)	Sum score on Negative Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by supporter in reference to supporter's reactions to survivor in past month. Range: 0 to 48; higher scores indicate more frequent negative reactions.	1 month
Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Self Report)	Sum score on Positive Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by supporter in reference to supporter's reactions to survivor in past month. Range: 0 to 16; higher scores indicate more frequent positive reactions.	1 month
Survivor Perceived Cultural Responsiveness of Intervention at 1 Month Post-baseline (Self Report)	Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.	1 month
Supporter Perceived Cultural Responsiveness of Intervention at 1 Month Post-baseline (Self Report)	Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.	1 month
Survivor Perceived Impact of Intervention at 1 Month Post-baseline (Self-report)	Sum score on survey created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.	1 month
Supporter Perceived Impact of Intervention at 1 Month Post-baseline (Self-report)	Sum score on survey created for this study, completed by supporter. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.	1 month
Change in Supporter Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)	Number of typical drinks per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.	Baseline, 3 months
Change in Supporter Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)	Number of typical drinking days per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.	Baseline, 3 months
Change in Supporter Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)	Number of typical drinking hours per week in past month reported by supporter on the Daily Drinking Questionnaire.	Baseline, 3 months
Change in Supporter Cannabis Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of cannabis use in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)	Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of non-prescription opioid use in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)	Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of methamphetamine use in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Cigarette Use Frequency at 3 Months Post-baseline (Self Report)	Number of days of cigarette use in past 2 weeks, as reported by supporter. Range: 0 to 14.	Baseline, 3 months
Change in Supporter Cigarette Use Quantity at 3 Months Post-baseline (Self Report)	Number of cigarettes smoked in a typical day in past 2 weeks, as reported by supporter.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Emily R Dworkin, PhD, University of Washington

Publications and helpful links

General Publications

• Dworkin ER, Ruzek JI, Cordova MJ, Fitzpatrick S, Merchant L, Stewart T, Santos JP, Mohr J, Bedard-Gilligan M. Supporter-focused early intervention for recent sexual assault survivors: Study protocol for a pilot randomized clinical trial. Contemp Clin Trials. 2022 Aug;119:106848. doi: 10.1016/j.cct.2022.106848. Epub 2022 Jul 9.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00011982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be archived in the National Archive of Criminal Justice Data. No direct or indirect identifiers will ever be included in the archived dataset. We will submit study instruments and data collection forms, project reports describing our methods, and Institutional Review Board documentation (including copies of consent forms). A syntax file will include (1) recoding of reverse-scored items; (2) calculation of scale scores; (3) addition of a filter variable indicating any cases not included in any final analyses and the corresponding reason for exclusion; and (5) variable and value labels. Technical documentation for the dataset will include variable codebooks with full study instruments and citations, naming conventions, missing value designations, value labels, known data anomalies, and a data user guide.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No