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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05345405
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Emily Dworkin, 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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Helping Behavior Help-Seeking Behavior Stress Relationship, Social Sexual Assault Sexual Violence Social Interaction Behavioral: Dyadic CARE Behavioral: Supporter-Only CARE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dyadic CARE
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
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.

Active Comparator: Supporter-Only CARE
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
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.

No Intervention: Waitlist Control
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.



Primary Outcome Measures :
  1. Survivor satisfaction with intervention at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Sum score on Client Satisfaction Scale, completed by survivor. Range: 8 to 32; higher scores indicate greater satisfaction

  2. Supporter satisfaction with intervention at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Sum score on Client Satisfaction Scale, completed by supporter. Range: 8 to 32; higher scores indicate greater satisfaction

  3. Change in survivor knowledge at 1 month post-baseline (self report) [ Time Frame: 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.

  4. Change in supporter knowledge at 1 month post-baseline (self report) [ Time Frame: 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.

  5. Change in survivor confusion about help-seeking behavior at 1 month post-baseline (self report) [ Time Frame: 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.

  6. Change in supporter confusion about helping behavior at 1 month post-baseline (self report) [ Time Frame: 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.

  7. Survivor disclosure frequency to supporter at 1 month post-baseline (self report) [ Time Frame: 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.

  8. Supporter overt hostile reactions to disclosure at 1 month post-baseline (informant report) [ Time Frame: 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.

  9. Supporter subtly unsupportive reactions to disclosure at 1 month post-baseline (informant report) [ Time Frame: 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.

  10. Supporter responsiveness at 1 month post-baseline (informant report) [ Time Frame: 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.

  11. Change in survivor PTSD symptom severity at 3 months post-baseline (self report) [ Time Frame: 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.

  12. Survivor provisional PTSD diagnostic status at 3 months post-baseline (self report) [ Time Frame: 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).

  13. Change in survivor stress at 3 months post-baseline (self report) [ Time Frame: 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.

  14. Change in supporter stress at 3 months post-baseline (self report) [ Time Frame: 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.

  15. Change in survivor perceived relationship quality at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Sum score on the Relationship Assessment Scale, completed by survivor. Range: 7 to 35; higher scores indicate greater relationship quality.

  16. Change in supporter perceived relationship quality at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Sum score on the Relationship Assessment Scale, completed by supporter. Range: 7 to 35; higher scores indicate greater relationship quality.


Secondary Outcome Measures :
  1. Survivor willingness to participate in criminal justice process at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Sum score score on measure created for this study, completed by survivor. Range: 0 to 10; higher scores indicate greater willingness.

  2. Survivor participation in criminal justice process at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Mean score on measure created for this study, completed by survivor. Range: 0 to 1; higher scores indicate greater participation.

  3. Change in survivor depression at 3 months post-baseline (self report) [ Time Frame: 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.

  4. Change in supporter depression at 3 months post-baseline (self report) [ Time Frame: 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.

  5. Change in survivor anxiety at 3 months post-baseline (self report) [ Time Frame: 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.

  6. Change in supporter anxiety at 3 months post-baseline (self report) [ Time Frame: 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.

  7. Change in survivor role impairment at 3 months post-baseline (self report) [ Time Frame: 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.

  8. Change in survivor social impairment at 3 months post-baseline (self report) [ Time Frame: 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.

  9. Change in survivor flourishing at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Sum score on Flourishing Index Measure, completed by survivor. Range: 0 to 120; higher scores indicate more flourishing.

  10. Change in supporter flourishing at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Sum score on Flourishing Index Measure, completed by supporter. Range: 0 to 120; higher scores indicate more flourishing.

  11. Survivor distress associated with supporter negative reactions at 1 month post-baseline (self report) [ Time Frame: 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.

  12. Supporter positive reactions to disclosure at 1 month post-baseline (informant report) [ Time Frame: 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.

  13. Change in survivor typical alcohol consumption (quantity) at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of typical drinks per week in past month reported by survivor on the Daily Drinking Questionnaire

  14. Change in survivor typical alcohol consumption (frequency) at 3 months post-baseline (self report) [ Time Frame: 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.

  15. Change in survivor typical alcohol consumption (hours) at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of typical drinking hours per week in past month reported by survivor on the Daily Drinking Questionnaire.

  16. Supporter perceived helping ineffectiveness at 1 month post-baseline (self report) [ Time Frame: 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.

  17. Supporter distress in helping at 1 month post-baseline (self report) [ Time Frame: 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.

  18. Supporter accommodation of survivor PTSD symptoms at 1 month post-baseline (self report) [ Time Frame: 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.

  19. Change in survivor cannabis use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of cannabis use in past 2 weeks, as reported by survivor. Range: 0 to 14.

  20. Change in survivor prescription opioid misuse frequency at 3 months post-baseline (self report) [ Time Frame: 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.

  21. Change in survivor non-prescription opioid use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of non-prescription opioid use in past 2 weeks, as reported by survivor. Range: 0 to 14.

  22. Change in survivor prescription amphetamine misuse frequency at 3 months post-baseline (self report) [ Time Frame: 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.

  23. Change in survivor methamphetamine use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of methamphetamine use in past 2 weeks, as reported by survivor. Range: 0 to 14.

  24. Change in survivor cigarette use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of cigarette use in past 2 weeks, as reported by survivor. Range: 0 to 14.

  25. Change in survivor cigarette use quantity at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of cigarettes smoked in a typical day in past 2 weeks, as reported by survivor.


Other Outcome Measures:
  1. Survivor disclosure frequency to supporter at 1 month post-baseline (informant report) [ Time Frame: 1 month ]
    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.

  2. Supporter negative reactions to disclosure at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    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.

  3. Supporter positive reactions to disclosure at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    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.

  4. Survivor perceived cultural responsiveness of intervention at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.

  5. Supporter perceived cultural responsiveness of intervention at 1 month post-baseline (self report) [ Time Frame: 1 month ]
    Sum score on survey created for this study, completed by survivor. Range: 4 to 16; higher scores indicate greater perceived cultural responsiveness of intervention.

  6. Survivor perceived impact of intervention at 1 month post-baseline (self-report) [ Time Frame: 1 month ]
    Sum score on survey created for this study, completed by survivor. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.

  7. Supporter perceived impact of intervention at 1 month post-baseline (self-report) [ Time Frame: 1 month ]
    Sum score on survey created for this study, completed by supporter. Range: 4 to 20; higher scores indicate greater perceived impact of intervention.

  8. Change in supporter typical alcohol consumption (quantity) at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of typical drinks per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.

  9. Change in supporter typical alcohol consumption (frequency) at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of typical drinking days per week in past month reported by supporter on the Daily Drinking Questionnaire. Range: 0 to 7.

  10. Change in supporter typical alcohol consumption (hours) at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of typical drinking hours per week in past month reported by supporter on the Daily Drinking Questionnaire.

  11. Change in supporter cannabis use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of cannabis use in past 2 weeks, as reported by supporter. Range: 0 to 14.

  12. Change in supporter prescription opioid misuse frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of prescription opioid use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.

  13. Change in supporter non-prescription opioid use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of non-prescription opioid use in past 2 weeks, as reported by supporter. Range: 0 to 14.

  14. Change in supporter prescription amphetamine misuse frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of prescription amphetamine use not as prescribed in past 2 weeks, as reported by supporter. Range: 0 to 14.

  15. Change in supporter methamphetamine use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of methamphetamine use in past 2 weeks, as reported by supporter. Range: 0 to 14.

  16. Change in supporter cigarette use frequency at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of days of cigarette use in past 2 weeks, as reported by supporter. Range: 0 to 14.

  17. Change in supporter cigarette use quantity at 3 months post-baseline (self report) [ Time Frame: Baseline, 3 months ]
    Number of cigarettes smoked in a typical day in past 2 weeks, as reported by supporter.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05345405


Contacts
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Contact: Emily R Dworkin, PhD 206-503-3287 edworkin@uw.edu

Locations
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United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98195-7238
Contact: Emily R Dworkin, PhD         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Emily R Dworkin, PhD University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily Dworkin, Assistant Professor, School of Medicine: Psychiatry, University of Washington
ClinicalTrials.gov Identifier: NCT05345405    
Other Study ID Numbers: STUDY00011982
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders