Clinical trial NCT04691492: Protecting Allies in Risky Situations
Official title: Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
College Drinking
Behavioral Changes
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-12-31
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Readiness to Intervene on the Readiness Ruler
timeFrame: Baseline and Monthly for 3 months
measure: Change in Readiness to Intervene on the Decisional Balance Scale
timeFrame: Baseline and 3 month follow up
measure: Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey
timeFrame: Baseline and Monthly for 3 months
measure: Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment
timeFrame: Baseline and Monthly for 3 months
measure: Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends
timeFrame: Baseline and Monthly for 3 months
measure: Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale
timeFrame: Baseline and Monthly for 3 months
measure: Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale
timeFrame: Baseline and Monthly for 3 months
Secondary outcomes:
measure: Sexual Assault
timeFrame: Monthly after baseline for 3 months
measure: Change in Drinking
timeFrame: Baseline and Monthly for 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Department of Psychology
state: New York
Study officials:
affiliation: University at Buffalo
name: Jennifer P Read, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: