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Protecting Allies in Risky Situations (PAIRS)

Primary Purpose

Sexual Assault, College Drinking, Behavioral Changes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Friend-Based Motivational Interview
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Assault

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female dyads who go out together at least once a week
  • Undergraduates enrolled in a 4-year college or university
  • Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly

Exclusion Criteria:

Not Applicable

Sites / Locations

  • University at Buffalo Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Friends-Based Motivational Interview (FMI) Group

Wait List Control

Arm Description

Will participate in the Friends-Based Motivational Interview (FMI) program.

The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).

Outcomes

Primary Outcome Measures

Change in Readiness to Intervene on the Readiness Ruler
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.
Change in Readiness to Intervene on the Decisional Balance Scale
The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.
Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey
This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior.
Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment
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.
Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends
The Bystander Behaviors Scale for Friends 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 (1) No I did not engage in this behavior, (2) Yes I did engage in this behavior, or (3) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.
Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale
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.
Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale
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.

Secondary Outcome Measures

Sexual Assault
Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior week. 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
Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption, on occasions when they were out with the target friend. Higher scores indicate greater alcohol consumption.

Full Information

First Posted
December 11, 2020
Last Updated
November 10, 2022
Sponsor
State University of New York at Buffalo
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04691492
Brief Title
Protecting Allies in Risky Situations
Acronym
PAIRS
Official Title
Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.
Detailed Description
The objective of the proposed study is to develop an innovative, friend-based motivational interview (FMI) that encourages and prepares friends to reduce sexual assault (SA) risk. Delivered to pairs of friends (dyads), the FMI will be designed to foster collaborative efforts to increase readiness for, and decrease barriers to helping behavior, and to teach and plan together for assault prevention skills. As the role of alcohol has been under-addressed in SA prevention efforts, the FMI also will explicitly attend to how intoxication may serve as a barrier to friend intervention, and strategies for overcoming this barrier. The completion of this project's aims will yield a novel intervention that capitalizes on the natural resource of women's friendships to decrease risk for sexual assault - a pervasive public health problem affecting a substantial portion of young adult women in the U.S. Twenty-four friend dyads will participate in the friend-based motivational interview (FMI) along with 24 wait-list control dyads (total of 48 dyads). The study will compare groups on outcomes at post-intervention and at bi-weekly 3 month follow-ups, and also examine within participant change. The study will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. It is expected that participants receiving the FMI will demonstrate significant increases in readiness, and engagement in friend assault prevention behavioral skills (FAPBs), and demonstrate decreases in perceived barriers, at post-intervention and over the 3-month follow-up. Follow-up data will be utilized to provide a rich description of the role of alcohol in implementing FAPBs, and whether the FMI reduces the impact of alcohol use. In exploratory analyses, it will be examined whether the intervention may be associated with decreased assault risk, as well as decreased drinking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Assault, College Drinking, Behavioral Changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Friends-Based Motivational Interview (FMI) Group
Arm Type
Experimental
Arm Description
Will participate in the Friends-Based Motivational Interview (FMI) program.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).
Intervention Type
Behavioral
Intervention Name(s)
Friend-Based Motivational Interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Readiness to Intervene on the Readiness Ruler
Description
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
Baseline and Bi-Weekly for 12 weeks following participation in the program
Title
Change in Readiness to Intervene on the Decisional Balance Scale
Description
The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.
Time Frame
Baseline and Bi-Weekly for 12 weeks following participation in the program
Title
Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey
Description
This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior.
Time Frame
Baseline, Immediately Following FMI Program Completion, Bi-Weekly for 12 weeks following participation in the program, 12-Week Follow Up
Title
Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment
Description
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
Baseline, Bi-Weekly for 12 weeks following participation in the program
Title
Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends
Description
The Bystander Behaviors Scale for Friends 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 (1) No I did not engage in this behavior, (2) Yes I did engage in this behavior, or (3) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.
Time Frame
Baseline, Bi-Weekly for 12 weeks following participation in the program
Title
Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale
Description
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
Baseline, 12 Week Follow-Up
Title
Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale
Description
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
Baseline, 12 Week Follow-Up
Secondary Outcome Measure Information:
Title
Sexual Assault
Description
Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior week. 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
Bi-Weekly for 12 weeks following participation in the program
Title
Change in Drinking
Description
Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption, on occasions when they were out with the target friend. Higher scores indicate greater alcohol consumption.
Time Frame
Bi-Weekly for 12 weeks following participation in the program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female dyads who go out together at least once a week Undergraduates enrolled in a 4-year college or university Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly Exclusion Criteria: Not Applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer P Read, Ph.D.
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo Department of Psychology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share a de-identified data set which will include baseline demographics and readiness to intervene, awareness of alcohol's effects on helping behaviors, friend-based assault protective strategy use, and perception of barriers to intervening outcomes.
IPD Sharing Time Frame
The data will become available in December 2021 and will be available until 2026.
IPD Sharing 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.

Learn more about this trial

Protecting Allies in Risky Situations

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