Supporter-Only CARE for Help-Seeking Behavior

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Washington School of Medicine, Seattle, WA
Help-Seeking Behavior+7 More
Dyadic CARE - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Help-Seeking Behavior
  • Moral Injury
  • Violence, Sexual
  • Helping Behavior
  • Social Interactions
  • Sexual Assault
  • Stress (Psychology)
  • Relationship, Social

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

20 Primary · 25 Secondary · Reporting Duration: 3 months

1 month
Supporter accommodation of survivor PTSD symptoms at 1 month post-baseline (self report)
Supporter distress in helping at 1 month post-baseline (self report)
Supporter negative reactions to disclosure at 1 month post-baseline (self report)
Supporter overt hostile reactions to disclosure at 1 month post-baseline (informant report)
Supporter perceived cultural responsiveness of intervention at 1 month post-baseline (self report)
Supporter perceived helping ineffectiveness at 1 month post-baseline (self report)
Supporter perceived impact of intervention at 1 month post-baseline (self-report)
Supporter positive reactions to disclosure at 1 month post-baseline (informant report)
Supporter positive reactions to disclosure at 1 month post-baseline (self report)
Supporter responsiveness at 1 month post-baseline (informant report)
Supporter satisfaction with intervention at 1 month post-baseline (self report)
Supporter subtly unsupportive reactions to disclosure at 1 month post-baseline (informant report)
Survivor disclosure frequency to supporter at 1 month post-baseline (informant report)
Survivor disclosure frequency to supporter at 1 month post-baseline (self report)
Survivor distress associated with supporter negative reactions at 1 month post-baseline (self report)
Survivor participation in criminal justice process at 1 month post-baseline (self report)
Survivor perceived cultural responsiveness of intervention at 1 month post-baseline (self report)
Survivor perceived impact of intervention at 1 month post-baseline (self-report)
Survivor satisfaction with intervention at 1 month post-baseline (self report)
Survivor willingness to participate in criminal justice process at 1 month post-baseline (self report)
3 months
Survivor provisional PTSD diagnostic status at 3 months post-baseline (self report)
Baseline, 1 month
Change in supporter confusion about helping behavior at 1 month post-baseline (self report)
Change in supporter knowledge at 1 month post-baseline (self report)
Change in survivor confusion about help-seeking behavior at 1 month post-baseline (self report)
Change in survivor knowledge at 1 month post-baseline (self report)
Baseline, 3 months
Change in supporter anxiety at 3 months post-baseline (self report)
Change in supporter cannabis use frequency at 3 months post-baseline (self report)
Change in supporter cigarette use frequency at 3 months post-baseline (self report)
Change in supporter cigarette use quantity at 3 months post-baseline (self report)
Change in supporter depression at 3 months post-baseline (self report)
Change in supporter flourishing at 3 months post-baseline (self report)
Change in supporter methamphetamine use frequency at 3 months post-baseline (self report)
Change in supporter non-prescription opioid use frequency at 3 months post-baseline (self report)
Change in supporter perceived relationship quality at 3 months post-baseline (self report)
Change in supporter prescription amphetamine misuse frequency at 3 months post-baseline (self report)
Change in supporter prescription opioid misuse frequency at 3 months post-baseline (self report)
Change in supporter stress at 3 months post-baseline (self report)
Change in supporter typical alcohol consumption (frequency) at 3 months post-baseline (self report)
Change in supporter typical alcohol consumption (hours) at 3 months post-baseline (self report)
Change in supporter typical alcohol consumption (quantity) at 3 months post-baseline (self report)
Change in survivor PTSD symptom severity at 3 months post-baseline (self report)
Change in survivor anxiety at 3 months post-baseline (self report)
Change in survivor cannabis use frequency at 3 months post-baseline (self report)
Change in survivor cigarette use frequency at 3 months post-baseline (self report)
Change in survivor cigarette use quantity at 3 months post-baseline (self report)
Change in survivor depression at 3 months post-baseline (self report)
Change in survivor flourishing at 3 months post-baseline (self report)
Change in survivor methamphetamine use frequency at 3 months post-baseline (self report)
Change in survivor non-prescription opioid use frequency at 3 months post-baseline (self report)
Change in survivor perceived relationship quality at 3 months post-baseline (self report)
Change in survivor prescription amphetamine misuse frequency at 3 months post-baseline (self report)
Change in survivor prescription opioid misuse frequency at 3 months post-baseline (self report)
Change in survivor role impairment at 3 months post-baseline (self report)
Change in survivor social impairment at 3 months post-baseline (self report)
Change in survivor stress at 3 months post-baseline (self report)
Change in survivor typical alcohol consumption (frequency) at 3 months post-baseline (self report)
Change in survivor typical alcohol consumption (hours) at 3 months post-baseline (self report)
Change in survivor typical alcohol consumption (quantity) at 3 months post-baseline (self report)
Baseline, following completion of first intervention session (average of 90 minutes post baseline)
Change in supporter confusion about helping behavior at post session 1 (self report)
Change in supporter knowledge at post session 1 (self report)
Change in survivor confusion about help-seeking behavior at post session 1 (self report)
Change in survivor knowledge at post session 1 (self report)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Waitlist Control
1 of 3
Supporter-Only CARE
1 of 3
Dyadic CARE
1 of 3
Active Control

144 Total Participants · 3 Treatment Groups

Primary Treatment: Supporter-Only CARE · No Placebo Group · N/A

Waitlist ControlNoIntervention Group · 1 Intervention: Waitlist Control · Intervention Types:
Supporter-Only CARE
Behavioral
ActiveComparator Group · 1 Intervention: Supporter-Only CARE · Intervention Types: Behavioral
Dyadic CARE
Behavioral
ActiveComparator Group · 1 Intervention: Dyadic CARE · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Trial Background

Prof. Emily Dworkin, Assistant Professor, School of Medicine: Psychiatry
Principal Investigator
University of Washington
Closest Location: University of Washington School of Medicine · Seattle, WA
Photo of Seattle  1Photo of Seattle  2Photo of Seattle  3
2004First Recorded Clinical Trial
1 TrialsResearching Help-Seeking Behavior
37 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have access to a Zoom-capable device.
You have elevated PTSD symptoms at screening as operationalized by a Primary Care PTSD Screen score of 2/5 or above.
You have a way to receive survey links and complete surveys privately (i.e.
You are able to attend the first study session within 2 weeks of the screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.