Prevention of Alcohol-related Sexual Revictimization in College (RPCW)
Assessing the Feasibility of a New Prevention to Reduce Alcohol-related Sexual Revictimization of College Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14203
- State University of New York Buffalo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Revictimization Prevention for College Women (RPCW)
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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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.
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Active Comparator: Health Education Control (HEC)
Time and attention control.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days Per Month Hazardous Drinking
Time Frame: Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up
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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.
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Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up
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Severe Sexual Assault (Revictimization)
Time Frame: At 6-month follow up
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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.
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At 6-month follow up
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Mean Number of Key Presses When Watching Risk Video
Time Frame: 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).
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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.
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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).
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Latency to Choose to Leave a Videotaped Scenario (Seconds)
Time Frame: 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).
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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.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficulties in Emotion Regulation Scale
Time Frame: Assessed at baseline, 3-month follow up, and 6-month follow up (trait)
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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. |
Assessed at baseline, 3-month follow up, and 6-month follow up (trait)
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State Difficulties in Emotion Regulation Scale
Time Frame: 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).
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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. |
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).
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The Protective Behavioral Strategies Scale
Time Frame: Assessed from baseline to the post-intervention survey; From post-intervention to the 3-month follow up; From 3- to 6-month follow up
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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. |
Assessed from baseline to the post-intervention survey; From post-intervention to the 3-month follow up; From 3- to 6-month follow up
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The Dating Self-Protection Against Rape Scale
Time Frame: Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow up
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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. |
Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow up
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Collaborators and Investigators
Investigators
- Principal Investigator: ParksMarsh A Kathleen, PhD, SUNY Buffalo
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 86140
- R34AA026910-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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