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

Primary Purpose

Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dyadic CARE
Supporter-Only CARE
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Dyadic CARE

Supporter-Only CARE

Waitlist Control

Arm Description

Participants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 6, 2022
Last Updated
July 29, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05345405
Brief Title
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
Acronym
CARE
Official Title
Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior, Stress, Relationship, Social, Sexual Assault, Sexual Violence, Social Interaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dyadic CARE
Arm Type
Active Comparator
Arm Description
Participants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3.
Arm Title
Supporter-Only CARE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dyadic CARE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supporter-Only CARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survivor satisfaction with intervention at 1 month post-baseline (self report)
Description
Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction
Time Frame
1 month
Title
Supporter satisfaction with intervention at 1 month post-baseline (self report)
Description
Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction
Time Frame
1 month
Title
Change in survivor knowledge at 1 month post-baseline (self report)
Description
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
Title
Change in supporter knowledge at 1 month post-baseline (self report)
Description
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
Title
Change in survivor confusion about help-seeking behavior at 1 month post-baseline (self report)
Description
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
Title
Change in supporter confusion about helping behavior at 1 month post-baseline (self report)
Description
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
Title
Survivor disclosure frequency to supporter at 1 month post-baseline (self report)
Description
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.
Time Frame
1 month
Title
Supporter overt hostile reactions to disclosure at 1 month post-baseline (informant report)
Description
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
Title
Supporter subtly unsupportive reactions to disclosure at 1 month post-baseline (informant report)
Description
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
Title
Supporter responsiveness at 1 month post-baseline (informant report)
Description
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
1 month
Title
Change in survivor PTSD symptom severity at 3 months post-baseline (self report)
Description
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
Title
Survivor provisional PTSD diagnostic status at 3 months post-baseline (self report)
Description
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
Title
Change in survivor stress at 3 months post-baseline (self report)
Description
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
Title
Change in supporter stress at 3 months post-baseline (self report)
Description
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
Title
Change in survivor perceived relationship quality at 3 months post-baseline (self report)
Description
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
Title
Change in supporter perceived relationship quality at 3 months post-baseline (self report)
Description
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
Secondary Outcome Measure Information:
Title
Survivor willingness to participate in criminal justice process at 1 month post-baseline (self report)
Description
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
Title
Survivor participation in criminal justice process at 1 month post-baseline (self report)
Description
Mean score on measure created for this study, completed by survivor. Range: 0 to 1; higher scores indicate greater participation.
Time Frame
1 month
Title
Change in survivor depression at 3 months post-baseline (self report)
Description
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
Title
Change in supporter depression at 3 months post-baseline (self report)
Description
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
Title
Change in survivor anxiety at 3 months post-baseline (self report)
Description
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
Title
Change in supporter anxiety at 3 months post-baseline (self report)
Description
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
Title
Change in survivor role impairment at 3 months post-baseline (self report)
Description
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
Title
Change in survivor social impairment at 3 months post-baseline (self report)
Description
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
Title
Change in survivor flourishing at 3 months post-baseline (self report)
Description
Sum score on Flourishing Index Measure, completed by survivor. Range: 0 to 120; higher scores indicate more flourishing.
Time Frame
Baseline, 3 months
Title
Change in supporter flourishing at 3 months post-baseline (self report)
Description
Sum score on Flourishing Index Measure, completed by supporter. Range: 0 to 120; higher scores indicate more flourishing.
Time Frame
Baseline, 3 months
Title
Survivor distress associated with supporter negative reactions at 1 month post-baseline (self report)
Description
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
Title
Supporter positive reactions to disclosure at 1 month post-baseline (informant report)
Description
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
Title
Change in survivor typical alcohol consumption (quantity) at 3 months post-baseline (self report)
Description
Number of typical drinks per week in past month reported by survivor on the Daily Drinking Questionnaire
Time Frame
Baseline, 3 months
Title
Change in survivor typical alcohol consumption (frequency) at 3 months post-baseline (self report)
Description
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
Title
Change in survivor typical alcohol consumption (hours) at 3 months post-baseline (self report)
Description
Number of typical drinking hours per week in past month reported by survivor on the Daily Drinking Questionnaire.
Time Frame
Baseline, 3 months
Title
Supporter perceived helping ineffectiveness at 1 month post-baseline (self report)
Description
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
Title
Supporter distress in helping at 1 month post-baseline (self report)
Description
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
Title
Supporter accommodation of survivor PTSD symptoms at 1 month post-baseline (self report)
Description
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
Title
Change in survivor cannabis use frequency at 3 months post-baseline (self report)
Description
Number of days of cannabis use in past 2 weeks, as reported by survivor. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in survivor prescription opioid misuse frequency at 3 months post-baseline (self report)
Description
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
Title
Change in survivor non-prescription opioid use frequency at 3 months post-baseline (self report)
Description
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
Title
Change in survivor prescription amphetamine misuse frequency at 3 months post-baseline (self report)
Description
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
Title
Change in survivor methamphetamine use frequency at 3 months post-baseline (self report)
Description
Number of days of methamphetamine use in past 2 weeks, as reported by survivor. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in survivor cigarette use frequency at 3 months post-baseline (self report)
Description
Number of days of cigarette use in past 2 weeks, as reported by survivor. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in survivor cigarette use quantity at 3 months post-baseline (self report)
Description
Number of cigarettes smoked in a typical day in past 2 weeks, as reported by survivor.
Time Frame
Baseline, 3 months
Other Pre-specified Outcome Measures:
Title
Survivor disclosure frequency to supporter at 1 month post-baseline (informant report)
Description
Single item representing frequency of survivor's disclosures to supporter in past month, completed by supporter. Range: 1 to 5; higher scores indicate more frequent disclosure.
Time Frame
1 month
Title
Supporter negative reactions to disclosure at 1 month post-baseline (self report)
Description
Sum score on Negative Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by supporter in reference to supporter's reactions to survivor in past month. Range: 0 to 48; higher scores indicate more frequent negative reactions.
Time Frame
1 month
Title
Supporter positive reactions to disclosure at 1 month post-baseline (self report)
Description
Sum score on Positive Reactions subscale of the Social Reactions Questionnaire - Shortened, completed by supporter in reference to supporter's reactions to survivor in past month. Range: 0 to 16; higher scores indicate more frequent positive reactions.
Time Frame
1 month
Title
Survivor perceived cultural responsiveness of intervention at 1 month post-baseline (self report)
Description
Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.
Time Frame
1 month
Title
Supporter perceived cultural responsiveness of intervention at 1 month post-baseline (self report)
Description
Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.
Time Frame
1 month
Title
Survivor perceived impact of intervention at 1 month post-baseline (self-report)
Description
Sum score on survey created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.
Time Frame
1 month
Title
Supporter perceived impact of intervention at 1 month post-baseline (self-report)
Description
Sum score on survey created for this study, completed by supporter. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.
Time Frame
1 month
Title
Change in supporter typical alcohol consumption (quantity) at 3 months post-baseline (self report)
Description
Number of typical drinks per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.
Time Frame
Baseline, 3 months
Title
Change in supporter typical alcohol consumption (frequency) at 3 months post-baseline (self report)
Description
Number of typical drinking days per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.
Time Frame
Baseline, 3 months
Title
Change in supporter typical alcohol consumption (hours) at 3 months post-baseline (self report)
Description
Number of typical drinking hours per week in past month reported by supporter on the Daily Drinking Questionnaire.
Time Frame
Baseline, 3 months
Title
Change in supporter cannabis use frequency at 3 months post-baseline (self report)
Description
Number of days of cannabis use in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter prescription opioid misuse frequency at 3 months post-baseline (self report)
Description
Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter non-prescription opioid use frequency at 3 months post-baseline (self report)
Description
Number of days of non-prescription opioid use in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter prescription amphetamine misuse frequency at 3 months post-baseline (self report)
Description
Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter methamphetamine use frequency at 3 months post-baseline (self report)
Description
Number of days of methamphetamine use in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter cigarette use frequency at 3 months post-baseline (self report)
Description
Number of days of cigarette use in past 2 weeks, as reported by supporter. Range: 0 to 14.
Time Frame
Baseline, 3 months
Title
Change in supporter cigarette use quantity at 3 months post-baseline (self report)
Description
Number of cigarettes smoked in a typical day in past 2 weeks, as reported by supporter.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily R Dworkin, PhD
Phone
206-503-3287
Email
edworkin@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily R Dworkin, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7238
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily R Dworkin, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be archived in the National Archive of Criminal Justice Data. No direct or indirect identifiers will ever be included in the archived dataset. We will submit study instruments and data collection forms, project reports describing our methods, and Institutional Review Board documentation (including copies of consent forms). A syntax file will include (1) recoding of reverse-scored items; (2) calculation of scale scores; (3) addition of a filter variable indicating any cases not included in any final analyses and the corresponding reason for exclusion; and (5) variable and value labels. Technical documentation for the dataset will include variable codebooks with full study instruments and citations, naming conventions, missing value designations, value labels, known data anomalies, and a data user guide.
Citations:
PubMed Identifier
35817294
Citation
Dworkin ER, Ruzek JI, Cordova MJ, Fitzpatrick S, Merchant L, Stewart T, Santos JP, Mohr J, Bedard-Gilligan M. Supporter-focused early intervention for recent sexual assault survivors: Study protocol for a pilot randomized clinical trial. Contemp Clin Trials. 2022 Aug;119:106848. doi: 10.1016/j.cct.2022.106848. Epub 2022 Jul 9.
Results Reference
derived

Learn more about this trial

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

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