Sexual ViolencePAIRSNCT07433270
PAIRS: Friend-Based AISA Intervention
A study testing Friend-Based Motivational Interview and Treatment as usual (TAU) in people with Sexual Violence and College Drinking, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence, College Drinking, Behavioral Changes
- What is being tested?
- Friend-Based Motivational Interview and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- 4 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
Who cannot join
- Can not speak and understand English sufficiently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo Department of Psychology
Buffalo, New York, 14260
Jennifer Read, 7168832574, jpread@buffalo.edu
About this study
Official title: Friend-based Intervention to Reduce Alcohol-Involved Sexual Assault Risk
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.
Read the detailed description
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.
- Conditions
- Sexual Violence, College Drinking, Behavioral Changes
- Being tested
- Friend-Based Motivational Interview, Treatment as usual (TAU)
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friend-Based Motivational InterviewBehavioural
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.
Treatment as usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FMI | Experimental | Not described Receives: Behavioral: Friend-Based Motivational Interview |
| treatment-as-usual | Active comparator | Not described Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start6 May 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Read, State University of New York at Buffalo
- Investigators
- Jennifer P Read, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433270
- Sponsor's protocol ID
- 00009969
- Acronym
- PAIRS
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Friend-based Intervention to Reduce Alcohol-Involved Sexual Assault Risk
- ClinicalTrials.gov ID
- NCT07433270
- Acronym / sponsor ID
- PAIRS / 00009969
- Conditions
- Sexual Violence, College Drinking, Behavioral Changes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMI | Experimental | Behavioral: Friend-Based Motivational Interview |
| treatment-as-usual | Active comparator | Behavioral: Treatment as usual (TAU) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- 4 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
Key exclusion criteria (1 listed)
- Can not speak and understand English sufficiently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Friend-Based Motivational InterviewThe 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. | Behavioural | FMI |
| 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. | Behavioural | treatment-as-usual |
Primary outcome
Alcohol-Involved 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
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.
Change in Drinking
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
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.
6 secondary outcomes
Change in 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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer P Read, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Friend-Based Motivational Interview and Treatment as usual (TAU) in people with Sexual Violence and College Drinking, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer P Read, Ph.D. (7166450193, jpread@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol-Involved 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.