Protecting Allies in Risky Situations (PAIRS)

• ClinicalTrials.gov Identifier: NCT04691492
• Recruitment Status: Completed
• First Posted: December 31, 2020
• Last Update Posted: November 14, 2022
• Sponsor: State University of New York at Buffalo
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Jennifer Read, State University of New York at Buffalo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sexual Assault; College Drinking; Behavioral Changes	Behavioral: Friend-Based Motivational Interview	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk
• Actual Study Start Date: July 15, 2021
• Actual Primary Completion Date: September 16, 2022
• Actual Study Completion Date: September 16, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Friends-Based Motivational Interview (FMI) Group; Will participate in the Friends-Based Motivational Interview (FMI) program.	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.
No Intervention: Wait List Control; The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).

Outcome Measures

Primary Outcome Measures :

1. Change in Readiness to Intervene on the Readiness Ruler [ Time Frame: Baseline and Bi-Weekly for 12 weeks following participation in the program ]
   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.
2. Change in Readiness to Intervene on the Decisional Balance Scale [ Time Frame: Baseline and Bi-Weekly for 12 weeks following participation in the program ]
   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.
3. Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey [ Time Frame: Baseline, Immediately Following FMI Program Completion, Bi-Weekly for 12 weeks following participation in the program, 12-Week Follow Up ]
   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.
4. Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment [ Time Frame: Baseline, Bi-Weekly for 12 weeks following participation in the program ]
   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.
5. Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends [ Time Frame: Baseline, Bi-Weekly for 12 weeks following participation in the program ]
   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.
6. Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale [ Time Frame: Baseline, 12 Week Follow-Up ]
   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.
7. Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale [ Time Frame: Baseline, 12 Week Follow-Up ]
   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.

Secondary Outcome Measures :

1. Sexual Assault [ Time Frame: Bi-Weekly for 12 weeks following participation in the program ]
   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.
2. Change in Drinking [ Time Frame: Bi-Weekly for 12 weeks following participation in the program ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 24 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

University at Buffalo Department of Psychology

Buffalo, New York, United States, 14260

Sponsors and Collaborators

State University of New York at Buffalo

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Jennifer P Read, Ph.D.; University at Buffalo

More Information

• Responsible Party: Jennifer Read, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT04691492
• Other Study ID Numbers: R34AA027046 ( U.S. NIH Grant/Contract ); R34AA027046 ( U.S. NIH Grant/Contract )
• First Posted: December 31, 2020
• Last Update Posted: November 14, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The investigators will share a de-identified data set which will include baseline demographics and readiness to intervene, awareness of alcohol's effects on helping behaviors, friend-based assault protective strategy use, and perception of barriers to intervening outcomes.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: The data will become available in December 2021 and will be available until 2026.
• Access Criteria: There must be an articulation of a clear research question and analytic plan by an established investigator with the relevant credentials. The information will be shared as a digital file through email.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alcohol Drinking in College; Alcohol Drinking; Drinking Behavior