Prevention of Alcohol-related Sexual Revictimization in College

NCT05257603 | Completed Results DMC

• 2 other identifiers: 86140R34AA026910-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Assault

Keywords

Intervention Study; Alcohol Drinking in College

Outcome Measures

Primary Outcomes (4)

• Days Per Month Hazardous Drinking

  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.

  Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up

• Severe Sexual Assault (Revictimization)

  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.

  At 6-month follow up

• Mean Number of Key Presses When Watching Risk Video

  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.

  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).

• Latency to Choose to Leave a Videotaped Scenario (Seconds)

  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.

  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 (4)

• Difficulties in Emotion Regulation Scale

  Assessed at baseline, 3-month follow up, and 6-month follow up (trait)

• 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).

• 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 Dating Self-Protection Against Rape Scale

  Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow up

Study Arms (2)

Revictimization Prevention for College Women (RPCW)

EXPERIMENTAL

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

Behavioral: RPCW

Health Education Control (HEC)

ACTIVE COMPARATOR

Time and attention control.

Behavioral: HEC

Interventions

RPCW 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.

Revictimization Prevention for College Women (RPCW)

HEC 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.

Health Education Control (HEC)

Eligibility Criteria

• Age: 18 Years - 22 Years
• Gender Eligibility Details: cis-gender female or non-binary, but must be sexually attracted to men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

State University of New York Buffalo

Buffalo, New York, 14203, United States

Location

Related 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.

  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.

  PMID: 3494755 BACKGROUND

• 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.

  PMID: 16329461 BACKGROUND

• 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.

  PMID: 17874881 BACKGROUND

• 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.

  PMID: 27747131 BACKGROUND

• 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.

  PMID: 26297011 BACKGROUND

• 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.

  PMID: 8113482 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol Drinking; Drinking Behavior; Behavior

Limitations and Caveats

Although 90 women were eligible for the study, only 72 started the randomized control trial (RCT) and attrition after 6 months was higher than expected, reducing power for detecting significant differences in primary outcomes between the intervention and control groups. Given the pilot nature of the RCT and the good acceptability and feasibility of the intervention, slight modifications to the recruitment and retention procedures are likely to produce better efficacy in a larger RCT.

Results Point of Contact

• Title: Dr. Kathleen Parks
• Organization: State University of New York at Buffalo

kparks@buffalo.edu

(716) 887-3301

Study Officials

• ParksMarsh A Kathleen, PhD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not told the outcomes the investigators are seeking to reduce, but are told participants are assigned to either a Health and Lifestyle intervention (Health Education control) or Managing High Risk intervention (RPCW).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: March 5, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: All information will be shared 6 months after findings are published.
• Access Criteria: Information will be available by contacting the PI of the study at kparks@buffalo.edu

Locations

US (1)