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

Not Applicable
Completed
Conditions
Sexual Assault
Stress
Social Interaction
Helping Behavior
Help-Seeking Behavior
Relationship, Social
Sexual Violence
Stress Disorders, Post-Traumatic
Interventions
Behavioral: Dyadic CARE
Behavioral: Supporter-Only CARE
Registration Number
NCT05345405
Lead Sponsor
University of Washington
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
126
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dyadic CAREDyadic CAREParticipants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.
Supporter-Only CARESupporter-Only CAREParticipants will receive supporter-only CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.
Primary Outcome Measures
NameTimeMethod
Change in survivor knowledge at 1 month post-baseline (self report)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 confusion about helping behavior at 1 month post-baseline (self report)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.

Supporter overt hostile reactions to disclosure at 1 month post-baseline (informant report)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 survivor confusion about help-seeking behavior at 1 month post-baseline (self report)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.

Supporter responsiveness at 1 month post-baseline (informant report)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.

Survivor satisfaction with intervention at 1 month post-baseline (self report)1 month

Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction

Supporter satisfaction with intervention at 1 month post-baseline (self report)1 month

Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction

Supporter subtly unsupportive reactions to disclosure at 1 month post-baseline (informant report)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)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.

Change in supporter knowledge at 1 month post-baseline (self report)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.

Survivor disclosure frequency to supporter at 1 month post-baseline (self report)1 month

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.

Change in supporter stress at 3 months post-baseline (self report)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 supporter perceived relationship quality at 3 months post-baseline (self report)Baseline, 3 months

Sum score on the Relationship Assessment Scale, completed by supporter. Range: 7 to 35; higher scores indicate greater relationship quality.

Change in survivor stress at 3 months post-baseline (self report)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.

Survivor provisional PTSD diagnostic status at 3 months post-baseline (self report)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 perceived relationship quality at 3 months post-baseline (self report)Baseline, 3 months

Sum score on the Relationship Assessment Scale, completed by survivor. Range: 7 to 35; higher scores indicate greater relationship quality.

Secondary Outcome Measures
NameTimeMethod
Change in survivor role impairment at 3 months post-baseline (self report)Baseline, 3 months

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.

Change in survivor social impairment at 3 months post-baseline (self report)Baseline, 3 months

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.

Change in survivor flourishing at 3 months post-baseline (self report)Baseline, 3 months

Sum score on Flourishing Index Measure, completed by survivor. Range: 0 to 120; higher scores indicate more flourishing.

Change in survivor typical alcohol consumption (frequency) at 3 months post-baseline (self report)Baseline, 3 months

Number of typical drinking days per week in past month reported by survivor on the Daily Drinking Questionnaire. Range: 0 to 7.

Survivor willingness to participate in criminal justice process at 1 month post-baseline (self report)1 month

Sum score score on measure created for this study, completed by survivor. Range: 0 to 10; higher scores indicate greater willingness.

Survivor participation in criminal justice process at 1 month post-baseline (self report)1 month

Mean score on measure created for this study, completed by survivor. Range: 0 to 1; higher scores indicate greater participation.

Change in survivor anxiety at 3 months post-baseline (self report)Baseline, 3 months

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.

Change in supporter flourishing at 3 months post-baseline (self report)Baseline, 3 months

Sum score on Flourishing Index Measure, completed by supporter. Range: 0 to 120; higher scores indicate more flourishing.

Survivor distress associated with supporter negative reactions at 1 month post-baseline (self report)1 month

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.

Change in survivor depression at 3 months post-baseline (self report)Baseline, 3 months

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.

Change in supporter depression at 3 months post-baseline (self report)Baseline, 3 months

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.

Supporter perceived helping ineffectiveness at 1 month post-baseline (self report)1 month

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.

Supporter distress in helping at 1 month post-baseline (self report)1 month

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.

Change in supporter anxiety at 3 months post-baseline (self report)Baseline, 3 months

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.

Supporter positive reactions to disclosure at 1 month post-baseline (informant report)1 month

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.

Change in survivor prescription amphetamine misuse frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14.

Change in survivor cigarette use frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of cigarette use in past 2 weeks, as reported by survivor. Range: 0 to 14.

Supporter accommodation of survivor PTSD symptoms at 1 month post-baseline (self report)1 month

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.

Change in survivor non-prescription opioid use frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of non-prescription opioid use in past 2 weeks, as reported by survivor. Range: 0 to 14.

Change in survivor typical alcohol consumption (quantity) at 3 months post-baseline (self report)Baseline, 3 months

Number of typical drinks per week in past month reported by survivor on the Daily Drinking Questionnaire

Change in survivor typical alcohol consumption (hours) at 3 months post-baseline (self report)Baseline, 3 months

Number of typical drinking hours per week in past month reported by survivor on the Daily Drinking Questionnaire.

Change in survivor cannabis use frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of cannabis use in past 2 weeks, as reported by survivor. Range: 0 to 14.

Change in survivor cigarette use quantity at 3 months post-baseline (self report)Baseline, 3 months

Number of cigarettes smoked in a typical day in past 2 weeks, as reported by survivor.

Change in survivor prescription opioid misuse frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by survivor. Range: 0 to 14.

Change in survivor methamphetamine use frequency at 3 months post-baseline (self report)Baseline, 3 months

Number of days of methamphetamine use in past 2 weeks, as reported by survivor. Range: 0 to 14.

Trial Locations

Locations (1)

University of Washington School of Medicine

🇺🇸

Seattle, Washington, United States

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