N/A
N=128
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
Stress Disorders, Post-Traumatic · Helping Behavior · Help-Seeking Behavior · Stress · Relationship, Social
Bottom Line
View on ClinicalTrials.gov: NCT05345405 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report) — 28.37; 27.71 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dyadic CARE (Behavioral); Supporter-Only CARE (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report) |
28.37; 27.71 | — |
| PRIMARY Supporter Satisfaction With Intervention at 1 Month Post-baseline (Self Report) |
29.79; 29.60 | — |
| PRIMARY Change in Survivor Knowledge at 1 Month Post-baseline (Self Report) |
3.24; 0.20; 0.61 | — |
| PRIMARY Change in Supporter Knowledge at 1 Month Post-baseline (Self Report) |
4.61; 4.84; 0.33 | — |
| PRIMARY Change in Survivor Confusion About Help-seeking Behavior at 1 Month Post-baseline (Self Report) |
-2.21; -1.14; 0.86 | — |
| PRIMARY Change in Supporter Confusion About Helping Behavior at 1 Month Post-baseline (Self Report) |
-4.35; -3.70; -1.85 | — |
| PRIMARY Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Self Report) |
2.67; 3.02; 2.66 | — |
| PRIMARY Supporter Overt Hostile Reactions to Disclosure at 1 Month Post-baseline (Informant Report) |
1.41; 2.96; 2.49 | — |
| PRIMARY Supporter Subtly Unsupportive Reactions to Disclosure at 1 Month Post-baseline (Informant Report) |
2.04; 2.23; 3.34 | — |
| PRIMARY Change in Supporter Responsiveness at 1 Month Post-baseline (Informant Report) |
-2.21; -0.10; 0.14 | — |
| PRIMARY Change in Survivor PTSD Symptom Severity at 3 Months Post-baseline (Self Report) |
-12.12; -16.58; -16.25 | — |
| PRIMARY Survivor Provisional PTSD Diagnostic Status at 3 Months Post-baseline (Self Report) |
8; 5; 9 | — |
| PRIMARY Change in Survivor Stress at 3 Months Post-baseline (Self Report) |
-1.66; -2.42; -1.38 | — |
| PRIMARY Change in Supporter Stress at 3 Months Post-baseline (Self Report) |
-2.15; -1.22; -0.65 | — |
| PRIMARY Change in Survivor Perceived Relationship Quality at 3 Months Post-baseline (Self Report) |
-0.39; -1.60; -1.76 | — |
| PRIMARY Change in Supporter Perceived Relationship Quality at 3 Months Post-baseline (Self Report) |
0.35; 0.39; -2.10 | — |
| SECONDARY Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report) |
-0.21; 0.57; -0.19 | — |
| SECONDARY Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report) |
0.64; 0.49; 0.52 | — |
| SECONDARY Change in Survivor Depression at 3 Months Post-baseline (Self Report) |
-1.58; -3.00; -2.52 | — |
| SECONDARY Change in Supporter Depression at 3 Months Post-baseline (Self Report) |
-0.80; -0.72; 0.44 | — |
| SECONDARY Change in Survivor Anxiety at 3 Months Post-baseline (Self Report) |
-1.53; -1.50; -2.10 | — |
| SECONDARY Change in Supporter Anxiety at 3 Months Post-baseline (Self Report) |
0.33; 1.00; 0.33 | — |
| SECONDARY Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report) |
-2.95; -3.75; -4.00 | — |
| SECONDARY Change in Survivor Social Impairment at 3 Months Post-baseline (Self Report) |
-3.21; -0.40; -1.57 | — |
| SECONDARY Change in Survivor Flourishing at 3 Months Post-baseline (Self Report) |
0.21; 2.89; -2.90 | — |
| SECONDARY Change in Supporter Flourishing at 3 Months Post-baseline (Self Report) |
1.65; 5.22; -7.33 | — |
| SECONDARY Survivor Distress Associated With Supporter Negative Reactions at 1 Month Post-baseline (Self Report) |
1.28; 1.50; 1.37 | — |
| SECONDARY Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Informant Report) |
8.56; 9.53; 8.56 | — |
| SECONDARY Change in Survivor Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report) |
0.58; -1.80; -0.25 | — |
| SECONDARY Change in Survivor Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report) |
0.32; -0.40; 0.25 | — |
| SECONDARY Change in Survivor Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report) |
1.32; -0.79; -1.95 | — |
| SECONDARY Supporter Perceived Helping Ineffectiveness at 1 Month Post-baseline (Self Report) |
12.13; 12.78; 14.57 | — |
| SECONDARY Supporter Distress in Helping at 1 Month Post-baseline (Self Report) |
53.59; 55.99; 61.57 | — |
| SECONDARY Supporter Accommodation of Survivor PTSD Symptoms at 1 Month Post-baseline (Self Report) |
12.78; 8.64; 17.66 | — |
| SECONDARY Change in Survivor Cannabis Use Frequency at 3 Months Post-baseline (Self Report) |
-0.11; 0.63; -1.62 | — |
| SECONDARY Change in Survivor Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report) |
— | — |
| SECONDARY Change in Survivor Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report) |
— | — |
| SECONDARY Change in Survivor Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report) |
0.11; -0.05; 0.24 | — |
| SECONDARY Change in Survivor Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report) |
0.16; 0.29; -0.19 | — |
| SECONDARY Change in Survivor Cigarette Use Frequency at 3 Months Post-baseline (Self Report) |
-0.05; -0.16; -0.10 | — |
| SECONDARY Change in Survivor Cigarette Use Quantity at 3 Months Post-baseline (Self Report) |
-0.01; -1.05; -0.62 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05345405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.