Prevention of Alcohol-related Sexual Revictimization in College

NCT ID: NCT05257603

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-05
• Study Completion Date: 2023-11-30

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.

Conditions

Sexual Assault

Keywords

Intervention Study; Alcohol Drinking in College

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Revictimization Prevention for College Women (RPCW)

Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.

Group Type: EXPERIMENTAL

RPCW

Intervention Type: BEHAVIORAL

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.

Health Education Control (HEC)

Time and attention control.

Group Type: ACTIVE_COMPARATOR

HEC

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Kathleen A Parks Marsh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ParksMarsh A Kathleen, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

State University of New York Buffalo

Buffalo, New York, United States

Countries

United States

References

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Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 3494755 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16329461 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17874881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27747131 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26297011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8113482 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AA026910-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

86140

Identifier Type: -

Identifier Source: org_study_id