Clinical trial NCT05345405: Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
Official title: Improving Social Support Quality Among Survivors Seeking Acute Post-Rape Care: Testing a Supporter-Targeted Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Helping Behavior
Help-Seeking Behavior
Stress
Relationship, Social
Sexual Assault
Sexual Violence
Social Interaction
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 128
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Survivor Satisfaction With Intervention at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Satisfaction With Intervention at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Change in Survivor Knowledge at 1 Month Post-baseline (Self Report)
timeFrame: Baseline, 1 month
measure: Change in Supporter Knowledge at 1 Month Post-baseline (Self Report)
timeFrame: Baseline, 1 month
measure: Change in Survivor Confusion About Help-seeking Behavior at 1 Month Post-baseline (Self Report)
timeFrame: Baseline, 1 month
measure: Change in Supporter Confusion About Helping Behavior at 1 Month Post-baseline (Self Report)
timeFrame: Baseline, 1 month
measure: Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Overt Hostile Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
timeFrame: 1 month
measure: Supporter Subtly Unsupportive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
timeFrame: 1 month
measure: Change in Supporter Responsiveness at 1 Month Post-baseline (Informant Report)
timeFrame: Baseline & 1 month
measure: Change in Survivor PTSD Symptom Severity at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Survivor Provisional PTSD Diagnostic Status at 3 Months Post-baseline (Self Report)
timeFrame: 3 months
measure: Change in Survivor Stress at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Stress at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Perceived Relationship Quality at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Perceived Relationship Quality at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Survivor Willingness to Participate in Criminal Justice Process at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Survivor Participation in Criminal Justice Process at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Change in Survivor Depression at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Depression at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Anxiety at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Anxiety at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Role Impairment at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Social Impairment at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Flourishing at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Flourishing at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Survivor Distress Associated With Supporter Negative Reactions at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Informant Report)
timeFrame: 1 month
measure: Change in Survivor Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Supporter Perceived Helping Ineffectiveness at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Distress in Helping at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Accommodation of Survivor PTSD Symptoms at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Change in Survivor Cannabis Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Cigarette Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Survivor Cigarette Use Quantity at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
Other outcomes:
measure: Survivor Disclosure Frequency to Supporter at 1 Month Post-baseline (Informant Report)
timeFrame: 1 month
measure: Supporter Negative Reactions to Disclosure at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Positive Reactions to Disclosure at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Survivor Perceived Cultural Responsiveness of Intervention at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Supporter Perceived Cultural Responsiveness of Intervention at 1 Month Post-baseline (Self Report)
timeFrame: 1 month
measure: Survivor Perceived Impact of Intervention at 1 Month Post-baseline (Self-report)
timeFrame: 1 month
measure: Supporter Perceived Impact of Intervention at 1 Month Post-baseline (Self-report)
timeFrame: 1 month
measure: Change in Supporter Typical Alcohol Consumption (Quantity) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Typical Alcohol Consumption (Frequency) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Typical Alcohol Consumption (Hours) at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Cannabis Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Prescription Opioid Misuse Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Non-prescription Opioid Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Prescription Amphetamine Misuse Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Methamphetamine Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Cigarette Use Frequency at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
measure: Change in Supporter Cigarette Use Quantity at 3 Months Post-baseline (Self Report)
timeFrame: Baseline, 3 months
Locations:
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Emily R Dworkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.