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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
128
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 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.
University of Washington School of Medicine
Seattle, Washington, United States
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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, adapted from the Early Intervention Clinic Disclosure scale. Survivor will input a numerical response representing number of disclosures. Higher scores indicate more frequent disclosure.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Change in 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.
Time frame: Baseline & 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months
Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months