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

University of Washington

Status: Completed

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

Treatments: Behavioral: Dyadic CARE; Behavioral: Supporter-Only CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT05345405

STUDY00011982

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 3 patient groups

Dyadic CARE

Active Comparator group

Description:

Participants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.

Treatment:

Behavioral: Dyadic CARE

Supporter-Only CARE

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supporter-Only CARE

Waitlist Control

No Intervention group

Description:

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.