Trials / Not Yet Recruiting
Not Yet RecruitingNCT07433270
PAIRS: Friend-Based AISA Intervention
Friend-based Intervention to Reduce Alcohol-Involved Sexual Assault Risk
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- Sponsor
- State University of New York at Buffalo · Academic / Other
- Sex
- Female
- Age
- 18 Years – 24 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
In this project we 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 we 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, we 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. We will compare the FMI to a standard sexual assault prevention intervention widely used on U.S. college campuses. We 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. We 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) we 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 we 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. We 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Treatment as usual (TAU) | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2030-03-01
- Completion
- 2030-08-01
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07433270. Inclusion in this directory is not an endorsement.