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

NCT05345405 | Completed Results

• 1 other identifier: STUDY00011982
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic; Helping Behavior; Help-Seeking Behavior; Stress; Relationship, Social; Sexual Assault; Sexual Violence; Social Interaction

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (25)

• Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report)

  1 month

• Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report)

  1 month

• Change in Survivor Depression at 3 Months Post-baseline (Self Report)

  Baseline, 3 months

• Change in Supporter Depression at 3 Months Post-baseline (Self Report)

  Baseline, 3 months

• Change in Survivor Anxiety at 3 Months Post-baseline (Self Report)

  Baseline, 3 months

Other Outcomes (17)

• Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Informant Report)

  1 month

• Supporter Negative Reactions to Disclosure at 1 Month Post-baseline (Self Report)

  1 month

• Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Self Report)

  1 month

Study Arms (3)

Dyadic CARE

ACTIVE COMPARATOR

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

Supporter-Only CARE

ACTIVE COMPARATOR

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

Waitlist Control

NO INTERVENTION

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.

Interventions

Dyadic CARE BEHAVIORAL

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.

Dyadic CARE

Supporter-Only CARE BEHAVIORAL

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.

Supporter-Only CARE

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• Active psychosis
• Active suicidal intent
• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington School of Medicine

Seattle, Washington, 98195-7238, United States

Location

Related Publications (1)

• 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.

  PMID: 35817294 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Helping Behavior; Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Social Behavior; Behavior

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Washington

edworkin@uw.edu

206-503-3287

Study Officials

• Emily R Dworkin, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 25, 2022
• Study Start: May 18, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

US (1)