Protecting Allies in Risky Situations (NCT04691492) | Clinical Trial Compass
CompletedNot Applicable
Protecting Allies in Risky Situations
United States108 participantsStarted 2021-07-15
Plain-language summary
The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.
Who can participate
Age range
18 Years – 24 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female dyads who go out together at least once a week
* Undergraduates enrolled in a 4-year college or university
* Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly
Exclusion Criteria:
Not Applicable
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Readiness to Intervene on the Readiness Ruler
Timeframe: Baseline and Monthly for 3 months
2
Change in Readiness to Intervene on the Decisional Balance Scale
Timeframe: Baseline and 3 month follow up
3
Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey
Timeframe: Baseline and Monthly for 3 months
4
Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment
Timeframe: Baseline and Monthly for 3 months
5
Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends
Timeframe: Baseline and Monthly for 3 months
6
Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale
Timeframe: Baseline and Monthly for 3 months
7
Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale