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Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
NA trial testing Dyadic CARE in Stress Disorders, Post-Traumatic in 128 participants. Completed in 4 July 2024.
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 128 |
| Start date | 18 May 2022 |
| Primary completion | 4 July 2024 |
| Estimated completion | 4 July 2024 |
| Sites | 1 location across United States |
University of Washington
14 and older, any sex, with Stress Disorders, Post-Traumatic or Helping Behavior. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 28.37 | ± 3.39 |
| Supporter-Only CARE (Survivors) | 27.71 | ± 3.51 |
Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Supporters) | 29.79 | ± 2.65 |
| Supporter-Only CARE (Supporters) | 29.60 | ± 2.28 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 3.24 | ± 3.70 |
| Supporter-Only CARE (Survivors) | 0.20 | ± 3.47 |
| Waitlist Control (Survivors) | 0.61 | ± 4.75 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Supporters) | 4.61 | ± 2.93 |
| Supporter-Only CARE (Supporters) | 4.84 | ± 3.55 |
| Waitlist Control (Supporters) | 0.33 | ± 2.54 |
Sum score on 4-item measure created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater confusion.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | -2.21 | ± 4.04 |
| Supporter-Only CARE (Survivors) | -1.14 | ± 3.64 |
| Waitlist Control (Survivors) | 0.86 | ± 4.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Supporters) | -4.35 | ± 3.88 |
| Supporter-Only CARE (Supporters) | -3.70 | ± 3.42 |
| Waitlist Control (Supporters) | -1.85 | ± 3.23 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 2.67 | ± 0.21 |
| Supporter-Only CARE (Survivors) | 3.02 | ± 0.21 |
| Waitlist Control (Survivors) | 2.66 | ± 0.21 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 1.41 | ± 0.53 |
| Supporter-Only CARE (Survivors) | 2.96 | ± 0.49 |
| Waitlist Control (Survivors) | 2.49 | ± 0.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 2.04 | ± 0.57 |
| Supporter-Only CARE (Survivors) | 2.23 | ± 0.52 |
| Waitlist Control (Survivors) | 3.34 | ± 0.54 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | -2.21 | ± 5.90 |
| Supporter-Only CARE (Survivors) | -0.10 | ± 7.49 |
| Waitlist Control (Survivors) | 0.14 | ± 8.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | -12.12 | ± 17.54 |
| Supporter-Only CARE (Survivors) | -16.58 | ± 13.32 |
| Waitlist Control (Survivors) | -16.25 | ± 13.32 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Dyadic CARE (Survivors) | 8 | |
| Supporter-Only CARE (Survivors) | 5 | |
| Waitlist Control (Survivors) | 9 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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