Protecting Allies in Risky Situations

Sexual Assault Clinical Trial

— PAIRS  

Official title:

Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691492
• Other study ID #: R34AA027046
• Secondary ID: R34AA027046
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: November 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of the proposed study is to develop an innovative, friend-based motivational interview (FMI) that encourages and prepares friends to reduce sexual assault (SA) risk. Delivered to pairs of friends (dyads), the FMI will be designed to foster collaborative efforts to increase readiness for, and decrease barriers to helping behavior, and to teach and plan together for assault prevention skills. As the role of alcohol has been under-addressed in SA prevention efforts, the FMI also will explicitly attend to how intoxication may serve as a barrier to friend intervention, and strategies for overcoming this barrier. The completion of this project's aims will yield a novel intervention that capitalizes on the natural resource of women's friendships to decrease risk for sexual assault - a pervasive public health problem affecting a substantial portion of young adult women in the U.S. Twenty-four friend dyads will participate in the friend-based motivational interview (FMI) along with 24 wait-list control dyads (total of 48 dyads). The study will compare groups on outcomes at post-intervention and at bi-weekly 3 month follow-ups, and also examine within participant change. The study will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. It is expected that participants receiving the FMI will demonstrate significant increases in readiness, and engagement in friend assault prevention behavioral skills (FAPBs), and demonstrate decreases in perceived barriers, at post-intervention and over the 3-month follow-up. Follow-up data will be utilized to provide a rich description of the role of alcohol in implementing FAPBs, and whether the FMI reduces the impact of alcohol use. In exploratory analyses, it will be examined whether the intervention may be associated with decreased assault risk, as well as decreased drinking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking in College
• Behavioral Changes
• College Drinking
• Sexual Assault

Intervention

Behavioral:
• Friend-Based Motivational Interview
The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping.

Locations

Country	Name	City	State
United States	University at Buffalo Department of Psychology	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Readiness to Intervene on the Readiness Ruler	Participants will use an 11-point likert-type scale modeled after the Readiness Ruler to rate their readiness for intervening. Responses range from 0 (I never think about my and/or my friend's risk of being sexually assaulted) to 10 (I am actively and consistently taking steps to protect myself and/or my friends from sexual assault), with higher scores indicating a greater readiness to intervene.	Baseline and Bi-Weekly for 12 weeks following participation in the program
Primary	Change in Readiness to Intervene on the Decisional Balance Scale	The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.	Baseline and Bi-Weekly for 12 weeks following participation in the program
Primary	Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey	This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior.	Baseline, Immediately Following FMI Program Completion, Bi-Weekly for 12 weeks following participation in the program, 12-Week Follow Up
Primary	Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment	The Friend-based Assault Protective Strategies Assessment uses 20 items to assess sexual assault preventive strategy use. Responses range from 1 (Not at all) to 4 (A lot), with higher scores indicating a greater use of strategies to prevent sexual assault.	Baseline, Bi-Weekly for 12 weeks following participation in the program
Primary	Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends	The Bystander Behaviors Scale for Friends is a 44-item measure which includes 4 sub-scales (1) the identification of sexual assault risk situations, (2) accessing resources, (3) planning ahead for risk situations, and (4) safety behaviors in risk settings. Response option include (1) No I did not engage in this behavior, (2) Yes I did engage in this behavior, or (3) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.	Baseline, Bi-Weekly for 12 weeks following participation in the program
Primary	Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale	The Barriers to Sexual Assault Bystander Intervention Scale is a 16-item measure to assess barriers to intervening. Responses range from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating greater perceived barriers to intervening.	Baseline, 12 Week Follow-Up
Primary	Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale	The Concerns About Intervening Scale uses 6 items to assess perceived barriers to intervening, focused on worries. Responses range from 1 (Not at all true) to 6 (Very much true), with higher scores indicating greater perceived barriers to intervening.	Baseline, 12 Week Follow-Up
Secondary	Sexual Assault	Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior week. Each item will be coded 1 (yes) or 0 (no), based on whether it happened to the woman/friend on each occasion that the pair socialized together.	Bi-Weekly for 12 weeks following participation in the program
Secondary	Change in Drinking	Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption, on occasions when they were out with the target friend. Higher scores indicate greater alcohol consumption.	Bi-Weekly for 12 weeks following participation in the program