NCT07261722

Brief Summary

The goal of this clinical trial is to test if a modified peer-based motivational intervention (the Military PAIRS; MPAIRS) is reasonable and practical for military contexts. The main questions it aims to answer are:

  • Does it works to reduce SV?
  • Does it works to reduce risky drinking? To test this, participants will answer questions about their SV history and risky drinking. Then they will be given MPAIRS. After 1 month, they will be asked about their SV history and risky drinking again.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Oct 2025Apr 2027

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

November 21, 2025

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Readiness to intervene

    10 item scale scored on a 5 point likert type scale with higher value indicating they are more ready to intervene on behalf of the other member of the dyad in areas of concern for abuse. Modeled after: Center for Evidence-Based Practices at Case Western Reserve University (2010). Readiness Ruler. Center for Evidence-Based Practices, Case Western Reserve University.

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

  • Peer -Directed Bystander Behaviors Scale for Friends

    44 item scale. The answers provided are yes/no/"I did not perceive an opportunity to do this" for each item in 3 different contexts (Friend, Stranger, Someone in Military). Each item is a situation that the participant may have been in to help someone in the past month. The participant reports if they did that helped, didn't help, or didn't have that situation for each context. Banyard, V. L., Moynihan, M. M., Cares, A. C., \& Warner, R. A. (2014). How do we know if it works? Defining measurable outcomes in bystander-focused violence prevention. Psychology of Violence, 4(1), 101-115.

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

  • Assault Protective Strategies

    20 item scale. It is scored on a 4 point likert type scale with an option for "I prefer to not answer" and an option for "I did not perceive an opportunity to do this". The scale is made up of items of strategies that people do either before going out, or while they are out to reduce risk for sexual assault. The participant reports to what extent they use each strategy with a higher number meaning they use the strategy to a greater extent.

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

  • PBSS-20 Alcohol Protective Strategy

    20 item scale. It is scored on a 6 point likert type scale. The scale is made up of items of different strategies people often use to protect against negative consequences of alcohol use. The participant reports to what extent they use each strategy with a higher number meaning they use the strategy to a greater extent. Treloar H, Martens MP, McCarthy DM. The Protective Behavioral Strategies Scale-20: improved content validity of the Serious Harm Reduction subscale. Psychol Assess. 2015 Mar;27(1):340-6. doi: 10.1037/pas0000071.

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

Secondary Outcomes (2)

  • Sexual Assault Experiences

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

  • Change in Drinking

    In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.

Study Arms (3)

Peer-Based Motivational Interview (PMI) (Phase One)

EXPERIMENTAL

Will participate in the Peer-Based Motivational Interview (PMI) intervention in Phase One

Behavioral: Peer-Based Motivational Interview

Peer-Based Motivational Interview (PMI) (Phase Two)

EXPERIMENTAL

Will participate in the Peer-Based Motivational Interview (PMI) intervention in Phase Two

Behavioral: Peer-Based Motivational Interview

Health and Well-Being for All

ACTIVE COMPARATOR

The control group for Phase Two will be Health and Well-Being For All intervention.

Behavioral: Health and Well-Being for All

Interventions

The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare service members to work together to reduce Sexual Violence (SV) risk. This intervention will target ways that the peer dyad may support, encourage, and share responsibility with one another in protecting against SV. The Peer-based MI (PMI) will then use the responsibility and relationship of peers as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the PMI will focus on the identification and implementation of skills peers can use to help one another prevent SV. PMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the PMI will encourage service members to identify personal, specific strategies for reducing the effects of alcohol on helping.

Peer-Based Motivational Interview (PMI) (Phase One)Peer-Based Motivational Interview (PMI) (Phase Two)

This single-session intervention, is designed to be delivered to peers in a group or dyad-based format, examines social determinants of health and wellness across a variety of domains. The intervention outlines a 6-step process for improving overall wellness. The CDC offers a number of handouts and other materials (e.g., peer dialogue exercises, data cards) that accompany the didactic material. In this study, the HWBA intervention will be delivered by a project interventionist. The session will be designed to be time equivalent (90 minutes) to the MPAIRs intervention. (Pember, 2018)

Health and Well-Being for All

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Enlisted U.S. Navy service members on active duty status
  • Meet criteria for risky drinking (i.e. score of 4+ for men, 2+ for women according to the AUDIT-C)
  • Have an eligible peer and the pair must socialize together at least twice a month

You may not qualify if:

  • Individuals who endorse evidence of withdrawal (Item 6 on the AUDIT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo Department of Psychology

Buffalo, New York, 14260, United States

RECRUITING

MeSH Terms

Interventions

HealthProto-Oncogene Proteins c-raf

Intervention Hierarchy (Ancestors)

Population Characteristicsraf KinasesMAP Kinase Kinase KinasesProtein Serine-Threonine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsProto-Oncogene ProteinsOncogene ProteinsNeoplasm Proteins

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
Model Details: There are two phases to this clinical trial. In the first Phase, there is no control group and participants are just being compared between at the time of the intervention and at follow up. This is a single group model In the second phase, there is a control group in a parallel model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SUNY Distinguished Professor and Chair of Department of Psychology

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

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, peer -directed bystander behaviors, peer-based assault protective strategy use, and Alcohol Protective Strategy outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available once data collection is completed and conclude 5 years after.
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