Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Supporter Satisfaction With Intervention at 1 Month Post-baseline (Self Report)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Supporter Satisfaction With Intervention at 1 Month Post-baseline (Self Report)
时间窗: 1 month
Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction
Change in Survivor Knowledge at 1 Month Post-baseline (Self Report)
时间窗: Baseline, 1 month
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.
Change in Supporter Knowledge at 1 Month Post-baseline (Self Report)
时间窗: Baseline, 1 month
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.
Change in Survivor Confusion About Help-seeking Behavior at 1 Month Post-baseline (Self Report)
时间窗: Baseline, 1 month
Sum score on 4-item measure created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater confusion.
Change in Supporter Confusion About Helping Behavior at 1 Month Post-baseline (Self Report)
时间窗: Baseline, 1 month
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.
Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Self Report)
时间窗: 1 month
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.
Supporter Overt Hostile Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
时间窗: 1 month
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.
Change in Supporter Responsiveness at 1 Month Post-baseline (Informant Report)
时间窗: Baseline & 1 month
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.
Change in Supporter Stress at 3 Months Post-baseline (Self Report)
时间窗: Baseline, 3 months
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.
Change in Survivor Perceived Relationship Quality at 3 Months Post-baseline (Self Report)
时间窗: Baseline, 3 months
Sum score on the Relationship Assessment Scale, completed by survivor. Range: 7 to 35; higher scores indicate greater relationship quality.
Supporter Subtly Unsupportive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
时间窗: 1 month
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.
Change in Survivor PTSD Symptom Severity at 3 Months Post-baseline (Self Report)
时间窗: Baseline, 3 months
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.
Survivor Provisional PTSD Diagnostic Status at 3 Months Post-baseline (Self Report)
时间窗: 3 months
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).
Change in Survivor Stress at 3 Months Post-baseline (Self Report)
时间窗: Baseline, 3 months
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.
Change in Supporter Perceived Relationship Quality at 3 Months Post-baseline (Self Report)
时间窗: Baseline, 3 months
Sum score on the Relationship Assessment Scale, completed by supporter. Range: 7 to 35; higher scores indicate greater relationship quality.
Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report)
时间窗: 1 month
Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction
次要结局
- Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report)(1 month)
- Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report)(1 month)
- Change in Survivor Depression at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Supporter Depression at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Anxiety at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Supporter Anxiety at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Survivor Distress Associated With Supporter Negative Reactions at 1 Month Post-baseline (Self Report)(1 month)
- Change in Survivor Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Social Impairment at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Flourishing at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Cigarette Use Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Supporter Flourishing at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)(1 month)
- Change in Survivor Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Supporter Perceived Helping Ineffectiveness at 1 Month Post-baseline (Self Report)(1 month)
- Supporter Accommodation of Survivor PTSD Symptoms at 1 Month Post-baseline (Self Report)(1 month)
- Change in Survivor Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Supporter Distress in Helping at 1 Month Post-baseline (Self Report)(1 month)
- Change in Survivor Cannabis Use Frequency at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
- Change in Survivor Cigarette Use Quantity at 3 Months Post-baseline (Self Report)(Baseline, 3 months)
研究者
Emily Dworkin
Assistant Professor, School of Medicine: Psychiatry
University of Washington
