An interventional study of Friend-Based Motivational Interview and Treatment as usual (TAU) in Sexual Violence, College Drinking and Behavioral Changes, sponsored by State University of New York at Buffalo. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention
This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up.
In this project the investigators will conduct a Phase 2 trial to test the efficacy of a friend-based motivational interview (FMI) compared to a treatment-as-usual (TAU) control, following participants over 1-year post-intervention (Aim 1.). With this trial the investigators also will address some key questions about FMI effects on target attitudes and behaviors (Aim 2.a.) that may be mechanisms of intervention outcome (Aim 2.b.). This includes Instrumental mechanisms (readiness, barriers, and assault protective behavior skills), and the dyadic relationship (closeness, collaboration between the friends in the dyad).
Aim 1. In a Phase 2 trial, the investigators will examine the efficacy of a friend-based motivational intervention (FMI) to reduce AISA risk relative to an active control condition over 1-year post-intervention.
The investigators will compare the FMI to a standard sexual assault prevention intervention widely used on U.S. college campuses. The investigators will use a three-level HLM, with repeated measures over one year (3, 6, 9, 12-month follow-up) nested within person (Level 2), and person nested within dyad (Level 3) to examine AISA outcomes. The investigators expect those in the FMI to report fewer incidences of AISA at follow-up assessments. Both AISA and assaults not involving alcohol will be examined.
Aim 2. Examine mechanisms (instrumental, relationship) of intervention effects. In this dyad-based FMI, an interdependent process may unfold that influences outcomes whereby the FMI influences AISA risk through a person's own change, as well as through their friend's change. It is important to distinguish these two processes as each may be an important part of intervention effects. Accordingly, with longitudinal Actor-Partner Interdependence Models (APIM, Cook \& Kenny, 2005; Kenny \& Ledermann, 2017) the investigators will test whether the intervention impacts mechanisms of change through actor (a person's own change), partner (friend's change) effects, or both (Aims 2a-2c).
Aim 2.a. Examine intervention effects on instrumental and relationships putative mediators, whether the putative predictors predict AISA.
In this aim the investigators will test pathways relevant to the proposed mediational pathways (intervention to mediator, and mediator to outcome).
Aim 2.b. Formally test actor (person's own change) mechanisms (indirect effects). Indirect effects through instrumental (readiness, FAPB skills, and perceived barriers) and relationship (closeness and collaboration) mechanisms will be tested. The investigators expect that the FMI will predict increases in closeness, collaboration, readiness, and FAPB skills, and decreases in perceived barriers, which in turn, will predict declines in AISA.
Aim 2.c. Formally test partner (friend's change) mechanisms (indirect effects). Indirect effects through friend's instrumental (readiness, FAPB skills, and perceived barriers) and relationship (closeness and collaboration) mechanisms will be tested. Because partner effects have not previously been examined, tests of partner effects are viewed as exploratory and no specific hypotheses are offered.
This Phase 2 trial will help to establish the efficacy of an intervention that harnesses the power of friends to address the significant public health problem of campus-based AISA. This study also will shed needed light on the mechanisms and complex nature of dyadic change that occurs in response to such an intervention. Findings will lay the groundwork for Phase 3 work.
38 studies on the registry are indexed under Alcohol Drinking in College; 8 are open to participants now.
This study's planned enrollment of 560 is above the median of 258 across 36 interventional studies indexed under Alcohol Drinking in College.
Browse Alcohol Drinking in College studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
Behavioral: Friend-Based Motivational Interview
Behavioral: Treatment as usual (TAU)
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.
This 65-minute single-session stand-alone course is a supplemental component of the EverFi (Vector Solutions) Sexual Assault Prevention for Undergraduate Students prevention suite that is administered in an online didactic format. All participants (intervention and control) will have completed the basic course of the Sexual Assault Prevention for Undergraduate Students at matriculation, per university requirements. For the current study, the supplemental Healthy Relationships component will be administered only to participants assigned to the control condition. Healthy Relationships focuses on relationship skills, strategies for taking action in risky situations, and intervention skill practice.
Alcohol-Involved Sexual Assault
Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior 2 weeks. 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.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change in Drinking
Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption. Higher scores indicate greater alcohol consumption.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change in Readiness to Intervene
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.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change in Peer-Directed Bystander Behaviors Scale for Strangers
We used a modified version of The Bystander Behaviors Scale for Strangers 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 (0) No I did not engage in this behavior, (1) Yes I did engage in this behavior, or (missing) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" (higher score) engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Changes to Assault Protective Strategies
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.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change to Barriers to Sexual Assault Bystander Intervention
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.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change to Concerns About Intervening
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.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Change to Bystander Intervention Behavior
This is a 10 item measure to assess the behaviors woman take to intervene in potentially risky situations. Each item is a statement and the participant rates on a 7 point likert type scale how much they agree (from strongly disagree to strongly agree) with a higher number indicating they strongly agree with the statement.
Time frame: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up
Plan to share: Yes — The investigators will share a de-identified data set which will include baseline demographics and readiness to intervene, friend-based assault protective strategy use, perception of barriers to intervening outcomes, alcohol use, and sexual assault outcomes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2030, 45 months after the start.
Of 23 interventional studies with no phase under Alcohol Drinking in College, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's planned 45 months is above that.
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