Clinical trial NCT05257603: Prevention of Alcohol-related Sexual Revictimization in College
Official title: Assessing the Feasibility of a New Prevention to Reduce Alcohol-related Sexual Revictimization of College Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Keywords: Intervention Study
Alcohol Drinking in College
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-25
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of participants will be assigned to the intervention (RPCW) condition designed to reduce hazardous drinking and increase awareness of risk cues for sexual assault and implementation of safe drinking and dating behaviors. Half of participants will be assigned to the Health education control designed to control for time and attention.
Primary purpose: PREVENTION

Brief summary: This pilot randomized controlled trial (RCT) is designed to test a new intervention designed to reduce college women's risk for sexual revictimization (SRV). The intervention targets women with a history of sexual assault (SA) and recent hazardous drinking (HD), as these women are at highest risk for SRV. The primary goals of the intervention are to decrease women's HD, improve their ability to perceive cues that signal risk for SRV, and strengthen their behavioral skills in situations associated with an increased risk for SRV. The intervention, Revictimization Prevention for College Women (RPCW) is a multi-modal intervention that includes two on-line interactive education modules and two in-person group skills-based training sessions that focus on problem solving training and behavioral rehearsal. The pilot RCT of the RPCW intervention will include 96 college women with follow-up assessments at 3- and 6-months post intervention. Women will be randomly assigned to either the RPCW intervention or to a Health Education Control (HEC) condition. The pilot RCT will be used to establish the feasibility of recruitment, the acceptability and safety of the RPCW intervention, and provide initial efficacy data that will assist in power calculations for a Stage II efficacy trial. The investigators hypothesize that women in RPCW intervention will report fewer days of hazardous drinking and improved perception of sexual assault risk cues compared with participants in the HEC condition. In addition, women in the RPCW intervention will report increased knowledge of safe dating practices and protective behavioral (drinking) strategies compared with participants in the HEC condition. Finally, women in the RPCW intervention will report lower rates of SRV as compared with participants in the HEC condition at the 6-month post-intervention follow-up.

Detailed description: The investigators will be conducting a Stage 1b randomized controlled trial of a newly developed preventive intervention to reduce sexual revictimization of college women. The preventive intervention, Revictimization Prevention for College Women (RPCW), is designed to reduce sexual revictimization by reducing women's hazardous drinking, and increasing their awareness of protective dating and drinking behavioral strategies, as well as their awareness of risk cues for sexual assault during social situations. The intervention involves two in-person group skills-based training sessions held one week apart and two online interactive educational sessions designed for completion between the in-person sessions. During the pilot RCT, the active intervention (RPCW) will be compared to a time and attention Health Education Control.

The first group session of the RPCW involves viewing 4 cue recognition training videos and participating in an Interventionist lead discussion intended to highlight sexual assault risk cues in each of the videos. After the session, each participant will then complete two interactive, online learning module focused on safe drinking and safe dating. The second group session will occur one week after the first and is designed to elicit feedback on the drinking and dating learning modules (e.g., length, ease of use, engagement, interest). The training videos will be viewed again individually and participants will engage in behavioral skills rehearsal of appropriate responses in paired role plays with feedback from the Interventionist and a group discussion about the emotional barriers to engaging in appropriate dating and drinking safety behaviors (e.g., "I feel bad for the guy", "He might get really mad, "I might miss out on being with a great guy") and strategies for overcoming these barriers. Adaptive emotion regulation strategies will be used such as cognitive reappraisal, distress tolerance, mindfulness of current emotions, acceptance, and problem solving. Immediately following this session, participants will be asked to complete a post-intervention survey, including feedback on the intervention content and process. Following the in-person RPCW sessions, a debriefing will occur to ensure that women have an opportunity to discuss any emotional discomfort or distress with the interventionist. Follow-up surveys will be administered again at 3- and 6-months post intervention. The Health education control (HEC) is a time and attention control and was developed in parallel with the RPCW. The two in-person sessions and two online units of the HEC condition will impart health information that is relevant and engaging for college women but does not directly address heavy drinking or sexual assault risk. It is intended to control for nonspecific intervention factors related to health behavior change. This 4-session active control condition will begin with an in-person session focused on stress management. The second in-person session focuses on sleep hygiene. The two online, interactive modules address nutrition on college campuses and physical exercise. These two modules are similar in format to the drinking and dating safety modules provided in the RPCW. To ensure that HEC participants receive SA risk reduction and HD reduction information, the participants will have the opportunity to receive the RPCW intervention following the 6-month follow-up assessment, if the participants choose to do so.

All participants will participate in the intervention over one week. The participants will attend two in-person group intervention sessions one week apart, and complete their two on-line units during the intervening week. The participants will be asked to complete a baseline survey prior to their first in-person session, a post-intervention session following their second in-person session and two follow-up on-line assessment surveys at 3 months and 6 months post intervention.

The investigators have three specific hypotheses for the RCT:

Hypothesis a: Participants in the RPCW intervention will report fewer days of hazardous drinking and improved perception of SRV risk cues on the video risk perception measure (primary outcomes) as compared with participants in the HEC condition.

Hypothesis b: Participants in the RPCW intervention will report increased knowledge of safe dating practices and protective behavioral (drinking) strategies (secondary outcomes) compared with participants in the HEC condition.

Hypothesis c: Participants in the RPCW intervention will report lower rates of SRV as compared with participants in the HEC condition at 6-month post-intervention follow-up.

Eligibility criteria: Inclusion Criteria:

* 18-22 years of age
* Current first- or second-year female student at the college
* Able to comprehend the study protocol, consent form and provide written consent
* Had a prior SA experienced since the age of 14 years (i.e., adolescent or young adult)
* Engaged in hazardous drinking in the past month (i.e., ≥ 4 drinks 1 or more times in past 30 days).

Exclusion Criteria:

* Major mental illness as indicated by: (a) severe level of depressive symptoms as assessed by the Beck Depression Inventory-II or a self-reported diagnosis of: (b) Schizophrenia, (c) Bipolar Disorder
* Report experiencing homicidal or suicidal ideation
* Unable to commit to attending 2 weekly in-person group sessions
* No access to a computer to complete the on-line intervention modules.

Primary outcomes:
measure: Days Per Month Hazardous Drinking
timeFrame: Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up
measure: Severe Sexual Assault (Revictimization)
timeFrame: At 6-month follow up
measure: Mean Number of Key Presses When Watching Risk Video
timeFrame: Change from the first in-person session to the second in person session of the intervention (2-weeks for Cohort 1 and 1-week for Cohort 2).
measure: Latency to Choose to Leave a Videotaped Scenario (Seconds)
timeFrame: Change from the first in-person session to the second in person session of the intervention (2-weeks for Cohort 1 and 1-week for Cohort 2).
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale
timeFrame: Assessed at baseline, 3-month follow up, and 6-month follow up (trait)
measure: State Difficulties in Emotion Regulation Scale
timeFrame: Change from the first in-person session to the second in person session of the intervention (2-weeks for Cohort 1 and 1-week for Cohort 2).
measure: The Protective Behavioral Strategies Scale
timeFrame: Assessed from baseline to the post-intervention survey; From post-intervention to the 3-month follow up; From 3- to 6-month follow up
measure: The Dating Self-Protection Against Rape Scale
timeFrame: Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow up
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York Buffalo
state: New York
Study officials:
affiliation: SUNY Buffalo
name: ParksMarsh A Kathleen, PhD
role: PRINCIPAL_INVESTIGATOR
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