Prevention of Alcohol-related Sexual Revictimization in College

Sexual Assault Clinical Trial

— RPCW  

Official title:

Assessing the Feasibility of a New Prevention to Reduce Alcohol-related Sexual Revictimization of College Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05257603
• Other study ID #: 86140
• Secondary ID: R34AA026910-01A1
• Status: Completed
• Phase: N/A
• Start date: February 19, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Assault

Intervention

Behavioral:
• RPCW
Psychosocial intervention that includes two in-person group sessions two weeks apart and two on-line units during the intervening two weeks. Behavioral training, educational materials, discussions and videos, as well as interactive online materials are included to increase awareness of sexual assault cues, dating and drinking protective behavioral strategies, barriers to defending oneself, and saying no to hazardous drinking and sexual advances.
• HEC
Health Education time and attention control that includes two in-person sessions two weeks apart and two on-line units during the intervening two weeks. The in-person sessions cover stress management and sleep, while the online units cover nutrition and physical activity. The in-person and online sessions are designed to foster discussion and be interactive.

Locations

Country	Name	City	State
United States	State University of New York Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gratz KL, Roemer, L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment. 2004; 26(1): 41-54.

Hanson KA, Gidycz CA. Evaluation of a sexual assault prevention program. J Consult Clin Psychol. 1993 Dec;61(6):1046-52. doi: 10.1037//0022-006x.61.6.1046. — View Citation

Koss MP, Gidycz CA, Wisniewski N. The scope of rape: incidence and prevalence of sexual aggression and victimization in a national sample of higher education students. J Consult Clin Psychol. 1987 Apr;55(2):162-70. doi: 10.1037//0022-006x.55.2.162. No abstract available. — View Citation

Lavender JM, Tull MT, DiLillo D, Messman-Moore T, Gratz KL. Development and Validation of a State-Based Measure of Emotion Dysregulation. Assessment. 2017 Mar;24(2):197-209. doi: 10.1177/1073191115601218. Epub 2016 Jul 27. — View Citation

Martens MP, Ferrier AG, Sheehy MJ, Corbett K, Anderson DA, Simmons A. Development of the Protective Behavioral Strategies Survey. J Stud Alcohol. 2005 Sep;66(5):698-705. doi: 10.15288/jsa.2005.66.698. — View Citation

Martens MP, Pederson ER, Labrie JW, Ferrier AG, Cimini MD. Measuring alcohol-related protective behavioral strategies among college students: further examination of the Protective Behavioral Strategies Scale. Psychol Addict Behav. 2007 Sep;21(3):307-15. doi: 10.1037/0893-164X.21.3.307. — View Citation

Parks KA, Levonyan-Radloff K, Dearing RL, Hequembourg A, Testa M. Development and Validation of a Video Measure for Assessing Women's Risk Perception for Alcohol-Related Sexual Assault. Psychol Violence. 2016 Oct;6(4):573-585. doi: 10.1037/a0039846. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of hazardous drinking days per week	A hazardous drinking day is defined as consumption of 4 or more drinks on a given day/drinking occasion during a typical week since the previous assessment.	Change from baseline to post-intervention (approximately 1 to 2-weeks); Change from post-intervention to 3-month follow up; Change from 3- to 6-month follow up
Primary	Change in the total number of hazardous drinking days over the past month	A hazardous drinking day is defined as consumption of 4 or more drinks on a given day/drinking occasion. Participants are asked to indicate the total number of hazardous drinking days over the past month.	Change from baseline to to 3-month follow up; Change from 3- to 6-month follow up
Primary	Sexual Assault (Revictimization)	Any form of sexual aggression as measured by the modified sexual experiences survey (Koss et al., 1987) since the intervention ended.	At 3-month follow up; At 6-month follow up
Primary	Change in ability to perceive sexual assault risk cues	Improved ability to perceive sexual assault cues is assessed by increased perception of risk cues on the Video Vignette Risk Perception Measure (Parks et al., 2016). Increase in risk perception as measured by increased number of risk cues recognized when watching the video measure. This is measured when a participant presses 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.	Change from the first in-person session to the second in person session of the intervention (1-week)
Secondary	Change in trait emotion regulation	Improvement in ability to regulate trait emotion regulation as assessed by the Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); 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. Positive change is indicated by an increase in total score (summed score of all items) from one time point to the next.	Change from baseline to 3-month follow up; Change from 3- to 6-month follow up (trait)
Secondary	Change in state emotion regulation	Improvement in ability to regulate state emotion regulation as assessed by the State Difficulties in Emotion Regulation Scale (Lavenender et al., 2017); This scale consists of 21 items measured on a scale from 1 "not at all" to 5 "completely." A higher score indicates greater ability to regulate emotions. Positive change is indicated by an increase in total score (summed score of all items) from one time point to the next.	Change from the first in-person session to the second in person session of the intervention (1-week)
Secondary	Change in the use of drinking protective behavioral strategies	Self-reported changes in the number of drinking protective behavioral strategies used as measured on the 15-item Protective Behavioral Strategies Scale (Martens et al., 2005; 2007). This is a count of the number of Protective Behavioral Strategies endorsed by a participant. A higher count indicates greater use or positive change in the use of these strategies.	Change from baseline to the post-intervention survey; Change from post-intervention to the 3-month follow up; Change from 3- to 6-month follow up
Secondary	Change in the use of dating protective strategies	Self-reported changes in the use of dating protective strategies with a dating or sexual partner as measured on the Dating Behavior Survey (Hanson & Gidycz, 1993). This is a 15-item measure that is assessed using a 7-point scale from 1 "Never" to 7 "Always." A higher score indicates greater use of dating protective strategies.	Change from baseline to post-intervention (1-week); Change from post-intervention to 3-month follow up; Change from 3- to 6-month follow up