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

Study Overview
=================
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.

Official Title
-----------------
Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention

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

Intervention / Treatment
-----------------
* Behavioral: Dyadic CARE
* Behavioral: Supporter-Only CARE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dyadic CARE<br>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<br>* 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.<br>|
| Active Comparator: Supporter-Only CARE<br>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<br>* 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.<br>|
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Survivor will input a numerical response. 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 | 
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivor willingness to participate in criminal justice process at 1 month post-baseline (self report) | Sum score score on measure created for this study, completed by survivor. Range: 0 to 10; higher scores indicate greater willingness. | 1 month | 
| Survivor participation in criminal justice process at 1 month post-baseline (self report) | Mean score on measure created for this study, completed by survivor. Range: 0 to 1; higher scores indicate greater participation. | 1 month | 
| Change in survivor depression at 3 months post-baseline (self report) | Sum score on the Depression 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 depression. | Baseline, 3 months | 
| Change in supporter depression at 3 months post-baseline (self report) | Sum score on the Depression 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 depression. | Baseline, 3 months | 
| Change in survivor anxiety at 3 months post-baseline (self report) | Sum score on the Anxiety 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 anxiety. | Baseline, 3 months | 
| Change in supporter anxiety at 3 months post-baseline (self report) | Sum score on the Anxiety 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 anxiety. | Baseline, 3 months | 
| Change in survivor role impairment at 3 months post-baseline (self report) | Sum score on Work/School/Responsibility Impairment subscale of the Behavioral Activation for Depression Scale (BADS), completed by survivor in reference to past week. Range: 0 to 30; higher scores indicate more impairment. | Baseline, 3 months | 
| Change in survivor social impairment at 3 months post-baseline (self report) | Sum score on Social Impairment subscale of the Behavioral Activation for Depression Scale (BADS), completed by survivor in reference to past week. Range: 0 to 30; higher scores indicate more impairment. | Baseline, 3 months | 
| Change in survivor flourishing at 3 months post-baseline (self report) | Sum score on Flourishing Index Measure, completed by survivor. Range: 0 to 120; higher scores indicate more flourishing. | Baseline, 3 months | 
| Change in supporter flourishing at 3 months post-baseline (self report) | Sum score on Flourishing Index Measure, completed by supporter. Range: 0 to 120; higher scores indicate more flourishing. | Baseline, 3 months | 
| Survivor distress associated with supporter negative reactions at 1 month post-baseline (self report) | Mean score on ratings of distress associated endorsed items on Negative Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions to survivor in past month. Range: 0 to 3; higher scores indicate more distress. | 1 month | 
| Supporter positive reactions to disclosure at 1 month post-baseline (informant report) | Sum score on Positive Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by survivor in reference to supporter's reactions in past month. Range: 0 to 16; higher scores indicate more frequent positive reactions. | 1 month | 
| Change in survivor typical alcohol consumption (quantity) at 3 months post-baseline (self report) | Number of typical drinks per week in past month reported by survivor on the Daily Drinking Questionnaire | Baseline, 3 months | 
| Change in survivor typical alcohol consumption (frequency) at 3 months post-baseline (self report) | Number of typical drinking days per week in past month reported by survivor on the Daily Drinking Questionnaire. Range: 0 to 7. | Baseline, 3 months | 
| Change in survivor typical alcohol consumption (hours) at 3 months post-baseline (self report) | Number of typical drinking hours per week in past month reported by survivor on the Daily Drinking Questionnaire. | Baseline, 3 months | 
| Supporter perceived helping ineffectiveness at 1 month post-baseline (self report) | Sum score on the Confusion subscale of the Impact on Friends measure, completed by supporter in reference to the past month. Range: 6 to 30; higher scores indicate greater perceived ineffectiveness. | 1 month | 
| Supporter distress in helping at 1 month post-baseline (self report) | Sum score on the Emotional Distress subscale of the Impact on Friends measure, completed by supporter in reference to the past month. Range: 24 to 120; higher scores indicate greater distress. | 1 month | 
| Supporter accommodation of survivor PTSD symptoms at 1 month post-baseline (self report) | Sum score on the Significant Others' Responses to Trauma Scale (SORTS), completed by supporter in reference to the past month. Range: 0 to 112; higher scores indicate greater accommodation. | 1 month | 
| Change in survivor cannabis use frequency at 3 months post-baseline (self report) | Number of days of cannabis use in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor prescription opioid misuse frequency at 3 months post-baseline (self report) | Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor non-prescription opioid use frequency at 3 months post-baseline (self report) | Number of days of non-prescription opioid use in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor prescription amphetamine misuse frequency at 3 months post-baseline (self report) | Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor methamphetamine use frequency at 3 months post-baseline (self report) | Number of days of methamphetamine use in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor cigarette use frequency at 3 months post-baseline (self report) | Number of days of cigarette use in past 2 weeks, as reported by survivor. Range: 0 to 14. | Baseline, 3 months | 
| Change in survivor cigarette use quantity at 3 months post-baseline (self report) | Number of cigarettes smoked in a typical day in past 2 weeks, as reported by survivor. | Baseline, 3 months |