NCT07433270

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Aug 2030

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

February 19, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

Secondary Outcomes (6)

  • Change in Readiness to Intervene

    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

    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

    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

    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

    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

  • +1 more secondary outcomes

Study Arms (2)

FMI

EXPERIMENTAL
Behavioral: Friend-Based Motivational Interview

treatment-as-usual

ACTIVE COMPARATOR
Behavioral: Treatment as usual (TAU)

Interventions

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.

FMI

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.

treatment-as-usual

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPeople who identify as women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • or more drinks in a single sitting 2 or more times monthly in the past 3 months
  • does not live at home with parents
  • reports going out (not necessarily drinking) with the other member of their dyad \> 1/week

You may not qualify if:

  • Can not speak and understand English sufficiently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo Department of Psychology

Buffalo, New York, 14260, United States

Location

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Study Officials

  • Jennifer P Read, Ph.D.

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer P Read, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SUNY Distinguished Professor and Chair of Department of Psychology

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations