Stress Disorders, Post-TraumaticCARENCT05345405
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
A study testing Dyadic CARE and Supporter-Only CARE in people with Stress Disorders, Post-Traumatic and Helping Behavior, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior
- What is being tested?
- Dyadic CARE and Supporter-Only CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
- 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)
Who cannot join
- Active psychosis
- Active suicidal intent
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Medicine
Seattle, Washington, 98195-7238
About this study
Official title: Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
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.
- Conditions
- Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior, Stress, Relationship, Social, Sexual Assault
- Being tested
- Dyadic CARE, Supporter-Only CARE
- Medical subject headings
- Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic CAREBehavioural
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 CAREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic CARE | Active comparator | Participants will receive dyadic CARE following baseline and will complete self-report assessments at post-session-1, Month 1, Month 2, and Month 3. Receives: Behavioral: Dyadic CARE |
| Supporter-Only CARE | Active comparator | 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. Receives: Behavioral: Supporter-Only CARE |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start18 May 2022
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Dworkin, University of Washington
- Investigators
- Emily R Dworkin, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345405
- Sponsor's protocol ID
- STUDY00011982
- Acronym
- CARE
- Status last verified
- Jun 2025
- First submitted
- 6 Apr 2022
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35817294
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
- ClinicalTrials.gov ID
- NCT05345405
- Acronym / sponsor ID
- CARE / STUDY00011982
- Conditions
- Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior, Stress, Relationship, Social, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dyadic CARE | Active comparator | Behavioral: Dyadic 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 CARE | Active comparator | Behavioral: Supporter-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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- Active psychosis
- Active suicidal intent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic CAREDyadic 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. | Behavioural | Dyadic CARE |
| Supporter-Only CARESupporter-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. | Behavioural | Supporter-Only CARE |
Primary outcome
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
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
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.
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.
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.
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.
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, 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)
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.
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.
Change in Supporter Responsiveness at 1 Month Post-baseline (Informant Report)
Time frame: 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 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.
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).
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.
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.
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.
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.
25 secondary outcomes
Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Change in Survivor Depression at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Supporter Depression at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Anxiety at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Supporter Anxiety at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Social Impairment at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Flourishing at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Supporter Flourishing at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Survivor Distress Associated With Supporter Negative Reactions at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
Time frame: 1 month
Change in Survivor Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Supporter Perceived Helping Ineffectiveness at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Supporter Distress in Helping at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Supporter Accommodation of Survivor PTSD Symptoms at 1 Month Post-baseline (Self Report)
Time frame: 1 month
Change in Survivor Cannabis Use Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Cigarette Use Frequency at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Change in Survivor Cigarette Use Quantity at 3 Months Post-baseline (Self Report)
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35817294Dworkin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily R Dworkin, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic CARE and Supporter-Only CARE in people with Stress Disorders, Post-Traumatic and Helping Behavior, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report) (time frame: 1 month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.