- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04691492
Protecting Allies in Risky Situations (PAIRS)
Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14260
- University at Buffalo Department of Psychology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Friends-Based Motivational Interview (FMI) Group
Will participate in the Friends-Based Motivational Interview (FMI) program.
|
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.
|
No Intervention: Wait List Control
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Readiness to Intervene on the Readiness Ruler
Time Frame: Baseline and Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Baseline and Bi-Weekly for 12 weeks following participation in the program
|
Change in Readiness to Intervene on the Decisional Balance Scale
Time Frame: Baseline and Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Baseline and Bi-Weekly for 12 weeks following participation in the program
|
Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey
Time Frame: Baseline, Immediately Following FMI Program Completion, Bi-Weekly for 12 weeks following participation in the program, 12-Week Follow Up
|
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.
|
Baseline, Immediately Following FMI Program Completion, Bi-Weekly for 12 weeks following participation in the program, 12-Week Follow Up
|
Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment
Time Frame: Baseline, Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Baseline, Bi-Weekly for 12 weeks following participation in the program
|
Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends
Time Frame: Baseline, Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Baseline, Bi-Weekly for 12 weeks following participation in the program
|
Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale
Time Frame: Baseline, 12 Week Follow-Up
|
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.
|
Baseline, 12 Week Follow-Up
|
Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale
Time Frame: Baseline, 12 Week Follow-Up
|
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.
|
Baseline, 12 Week Follow-Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Assault
Time Frame: Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Bi-Weekly for 12 weeks following participation in the program
|
Change in Drinking
Time Frame: Bi-Weekly for 12 weeks following participation in the program
|
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.
|
Bi-Weekly for 12 weeks following participation in the program
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer P Read, Ph.D., University at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34AA027046 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on College Drinking
-
University of MinnesotaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Michigan and other collaboratorsCompleted
-
Penn State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes...Active, not recruitingUnderage Drinking | Driving Under the Influence | Drinking, Teen | Drinking, CollegeUnited States
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedCollege Student DrinkingUnited States
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedCollege Student Drinking
-
Penn State UniversityRecruitingCannabis Use | College Drinking | Underage Drinking | Drinking, Teen | Drinking, College | Teen DrinkingUnited States
-
Brown UniversityCompleted
-
Boston University Charles River CampusRecruiting
Clinical Trials on Friend-Based Motivational Interview
-
University of SurreyThe Leeds Teaching Hospitals NHS Trust; University Hospital Birmingham NHS... and other collaboratorsRecruitingYoung People With All Long-term Health ConditionsUnited Kingdom
-
Semmelweis UniversityRecruiting
-
Aslı MemisNot yet recruitingAdolescent | Behavior, Addictive | Motivation | Digital TechnologyTurkey
-
Ohio UniversityNew York Blood CenterCompleted
-
Centro Hospitalar Lisboa NorteUniversity of Lisbon; Faculdade de Psicologia e de Ciências de Educação da...Unknown
-
Kahramanmaras Sutcu Imam UniversityEnrolling by invitation
-
T.C. ORDU ÜNİVERSİTESİCompleted
-
Abdullah GerçekCompletedHemodialysis Complication | Motivation | Patient ComplianceTurkey
-
Istanbul University-CerrahpasaCompleted