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

NCT ID: NCT05345405

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-07-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dyadic CARE

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Supporter-Only CARE

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Emily Dworkin

Assistant Professor, School of Medicine: Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily R Dworkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington School of Medicine

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35817294 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

STUDY00011982

Identifier Type: -

Identifier Source: org_study_id