Prevention of Alcohol-related Sexual Revictimization in College

Not Applicable

Completed

Conditions: Sexual Assault

Interventions: Behavioral: HEC
Behavioral: RPCW

Registration Number: NCT05257603

Lead Sponsor: State University of New York at Buffalo

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 72

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education Control (HEC)	HEC	Time and attention control.
Revictimization Prevention for College Women (RPCW)	RPCW	Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.

Primary Outcome Measures

Name	Time	Method
Days Per Month Hazardous Drinking	Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up	A hazardous drinking day is defined as consumption of 4 or more drinks on a given day/drinking occasion during a month. Average number of hazardous drinking days per month will be assessed at each assessment interval.
Severe Sexual Assault (Revictimization)	At 6-month follow up	Any form of severe sexual aggression greater than unwanted contact/touching as measured by the modified sexual experiences survey (Koss et al., 1987) since the intervention ended.
Mean Number of Key Presses When Watching Risk Video	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).	Improved ability to perceive sexual assault risk was assessed by participants' responses while watching the high- risk video from the Video Vignette Risk Perception Measure (Parks et al., 2016). Increased perception of risk was measured by an increase in the number of times an individual indicated concern when watching the video as measured by pressing a specified key (e.g., "b") on the computer keyboard in response to feeling concerned or uncomfortable while watching the social interaction in the video. An improvement in risk perception was indicated by a higher mean number of key presses. Therefore, a higher mean number of key presses at time 2 compared to time 1 would indicate improved risk perception.
Latency to Choose to Leave a Videotaped Scenario (Seconds)	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).	Time taken (Latency measured in seconds) to indicate a desire to leave a video depiction of a social interaction embedded with high-risk cues for sexual assault. Participants indicate when they are concerned about their sexual safety and would choose to exit the scenario if this were a live interaction by pressing a designated key on the computer keyboard (e.g., u). The measure is administered prior to and after the intervention and control condition, one week apart. A difference score (Time 2 - Time 1) is calculated. A reduced latency to choose to leave the scenario (i.e., choosing to leave more quickly) - indicates better recognition of risk.

Secondary Outcome Measures

Name	Time	Method
Difficulties in Emotion Regulation Scale	Assessed at baseline, 3-month follow up, and 6-month follow up (trait)	Difficulties in Emotion Regulation Scale was used to assess emotion regulation; This scale consists of 36 items measured on a scale from 1 "almost never" to 5 "almost always." A higher score indicates greater ability to regulate emotions. Improvement would be an increase in score from time 1 to time 2. Minimum value is 36, Maximum value is 180. A higher score indicates a better outcome.
State Difficulties in Emotion Regulation Scale	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).	Improvement in ability to regulate state emotion regulation as assessed by the State Difficulties in Emotion Regulation Scale; This scale consists of 21 items measured on a scale from 1 "not at all" to 5 "completely." A higher score is better, indicating greater ability to regulate emotions. Improvement in ability to regulate emotions is indicated by an increase in total score (summed score of all items, items on the awareness subscale are reverse coded before summing) from one time point to the next. Minimum score is 21, Maximum score is 105. A higher score means a better outcome.
The Protective Behavioral Strategies Scale	Assessed from baseline to the post-intervention survey; From post-intervention to the 3-month follow up; From 3- to 6-month follow up	The Protective Behavioral Strategies Scale (PBSS; 15-items; Martens et al., 2005; 2007) was used to assess use of drinking protective behavioral strategies. Each item is scored on frequency of use from 1 'never' to 6 'always' and summed for a total score, with higher scores indicating better use of drinking protective behavior strategies. Minimum value is 15, Maximum value is 90. Higher scores indicate a better outcome.
The Dating Self-Protection Against Rape Scale	Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow up	The Dating Self-Protection against Rape Scale (DSPARS; Moore \& Waterman, 1999; Scaglione et al., 2015) was used to assess 15 dating protective strategies. Each item is assessed using a 7-point scale from 1 "Never" to 7 "Always." A lower score is better, indicating less risky dating behavior. Minimum score is 15, maximum score is 105. Lower scores mean better outcome.