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Supporter-Targeted Intervention for Sexual Assault Survivors (CARE Trial)

N/A

Recruiting

Led By Emily R Dworkin, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Can speak/read English or Spanish

Age 14+ years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

CARE Trial Summary

This trial is testing whether a 2-session intervention called CARE can help improve supporters' ability to respond effectively to survivors of sexual assault. There are two versions of CARE being tested: one in which survivors and supporters attend both sessions together, and one in which supporters attend sessions alone.

Who is the study for?

This trial is for individuals aged 14 or older who have experienced recent sexual assault and show signs of post-traumatic stress. They must be in regular contact with a supporter, have access to Zoom, and can attend sessions soon after screening. Both English or Spanish speakers are welcome. Supporters cannot participate if they might breach the survivor's privacy.Check my eligibility

What is being tested?

The trial tests two versions of CARE: one where survivors and their supporters attend recovery sessions together (dyadic CARE), and another where only supporters do so (supporter-only CARE). Participants will be randomly assigned to these interventions or placed on a waitlist, with assessments over three months.See study design

What are the potential side effects?

Since this intervention involves psychological support rather than medication, traditional side effects are not expected. However, discussing traumatic events may temporarily increase distress or emotional discomfort.

CARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak and read either English or Spanish.

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I am 14 years old or older.

CARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 supporter perceived relationship quality at 3 months post-baseline (self report)

+13 more

Secondary outcome measures

Change in supporter anxiety 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)

+22 more

Other outcome measures

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)

+14 more

CARE Trial Design

3Treatment groups

Active Control

Group I: Dyadic CAREActive Control1 Intervention

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

Group II: Waitlist ControlActive Control1 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.

Group III: Supporter-Only CAREActive Control1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,794 Total Patients Enrolled

1 Trials studying Sexual Assault

200 Patients Enrolled for Sexual Assault

Emily R Dworkin, PhDPrincipal InvestigatorUniversity of Washington

Media Library

Dyadic CARE Clinical Trial Eligibility Overview. Trial Name: NCT05345405 — N/A

Sexual Assault Research Study Groups: Dyadic CARE, Waitlist Control, Supporter-Only CARE

Sexual Assault Clinical Trial 2023: Dyadic CARE Highlights & Side Effects. Trial Name: NCT05345405 — N/A

Dyadic CARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345405 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this research trial began in May 18th 2022 and is still recruiting participants as of the last update on May 26th 2022. 144 patients are required for enrollment across a single medical facility."

Answered by AI

What is the intended outcome of this clinical experiment?

"The primary goal of this trial, assessed at Baseline and 90 minutes following the initial intervention session (average), is to gauge how well supporters understand appropriate helping behaviour. Secondary outcomes include a change in supporter depression levels three months post-baseline, survivor role impairment at 3 months post-baseline as measured by the Behavioral Activation for Depression Scale (BADS) subscale score, and survivor alcohol consumption hours per week over the past month according to data gathered from Daily Drinking Questionnaires."

Answered by AI

Is enrollment still open for this medical experiment?

"That is correct. According to clinicaltrials.gov, this research study has an ongoing recruitment process that began on May 18th 2022 and was last updated on the 26th of the same month. The investigators are aiming for a total sample size of 144 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Emily Dworkin 2022. "Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05345405.

All > Post Traumatic Stress Disorder > Ptsd