Trial Outcomes & Findings for Prevention of Alcohol-related Sexual Revictimization in College (NCT NCT05257603)
NCT ID: NCT05257603
Last Updated: 2024-12-31
Results Overview
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.
COMPLETED
NA
72 participants
Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up
2024-12-31
Participant Flow
Participants were recruited via email and through fliers posted on campus. Cohort 1 was recruited and screened for eligibility over the telephone between February 2, 2022 and April 19, 2022. Cohort 2 was recruited and screened for eligibility over the telephone between September 7, 2022 and April 11, 2023.
Participants who were screened as eligible, provided informed consent to participate, were assigned to condition and completed the first in-person session of the study protocol were considered to have entered the controlled trial. Therefore, participants could have been eligible, consented and assigned to condition, but if they did not complete the baseline measure or attend the first in-person session, they would not have been considered a participant in the clinical trial.
Participant milestones
| Measure |
Revictimization Prevention for College Women (RPCW)
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
RPCW: Psychosocial intervention that includes two in-person group sessions two weeks apart (Cohort 1) or one week apart (Cohort 2) with 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.
HEC: Health Education time and attention control that includes two in-person sessions two weeks apart (Cohort 1) or one week apart (Cohort 2) with 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.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
|
Overall Study
Cohort 1: Completers of Two-week Protocol
|
8
|
5
|
|
Overall Study
Cohort 2: Completers of One-week Protocol
|
22
|
25
|
|
Overall Study
Completed Partial Protocol.
|
7
|
5
|
|
Overall Study
Post-Intervention Survey
|
33
|
29
|
|
Overall Study
3-Month Follow-up Survey
|
32
|
26
|
|
Overall Study
Completed One or More Follow-up Visits
|
35
|
33
|
|
Overall Study
6-Month Follow-up Survey
|
29
|
22
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Alcohol-related Sexual Revictimization in College
Baseline characteristics by cohort
| Measure |
Revictimization Prevention for College Women (RPCW)
n=37 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=35 Participants
Time and attention control.
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.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
cis-gender female
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow upPopulation: Change in number of participants analyzed in different rows indicates the number of participants who completed each of the follow-up measurements. In other words, it indicates the attrition from follow-up after completing the intervention. This was an intent to treat analysis, so all participants were included.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=37 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=35 Participants
Time and attention control.
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.
|
|---|---|---|
|
Days Per Month Hazardous Drinking
Baseline
|
7.54 Days per Month Hazardous Drinking
Standard Deviation 6.55
|
10.40 Days per Month Hazardous Drinking
Standard Deviation 11.51
|
|
Days Per Month Hazardous Drinking
Post-Intervention
|
1.97 Days per Month Hazardous Drinking
Standard Deviation 2.80
|
1.53 Days per Month Hazardous Drinking
Standard Deviation 1.91
|
|
Days Per Month Hazardous Drinking
3-Month Follow Up
|
3.72 Days per Month Hazardous Drinking
Standard Deviation 4.24
|
3.52 Days per Month Hazardous Drinking
Standard Deviation 6.30
|
|
Days Per Month Hazardous Drinking
6-Month Follow Up
|
4.89 Days per Month Hazardous Drinking
Standard Deviation 6.85
|
3.89 Days per Month Hazardous Drinking
Standard Deviation 4.87
|
PRIMARY outcome
Timeframe: At 6-month follow upAny 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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=37 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=35 Participants
Time and attention control.
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.
|
|---|---|---|
|
Severe Sexual Assault (Revictimization)
Not Sexually Assaulted
|
32 Participants
|
28 Participants
|
|
Severe Sexual Assault (Revictimization)
Sexually Assaulted
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 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).Population: Only those women who completed both of the in-person group sessions and provided complete data for the risk perception measure were analyzed for this outcome.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=19 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=22 Participants
Time and attention control.
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.
|
|---|---|---|
|
Mean Number of Key Presses When Watching Risk Video
|
6.58 number of key presses
Standard Deviation 3.24
|
6.64 number of key presses
Standard Deviation 8.98
|
PRIMARY outcome
Timeframe: 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).Population: Individuals who had completed measure at both pre-intervention and post-intervention were included in analysis.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=15 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=11 Participants
Time and attention control.
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.
|
|---|---|---|
|
Latency to Choose to Leave a Videotaped Scenario (Seconds)
|
-21.17 Seconds
Standard Deviation 23.36
|
-6.34 Seconds
Standard Deviation 70.70
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3-month follow up, and 6-month follow up (trait)Population: Participants who completed the measure at all 3 time points were included in the analysis.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=27 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=18 Participants
Time and attention control.
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.
|
|---|---|---|
|
Difficulties in Emotion Regulation Scale
Baseline
|
92.44 score on a scale
Standard Deviation 28.59
|
87.39 score on a scale
Standard Deviation 15.26
|
|
Difficulties in Emotion Regulation Scale
3-month Follow-up
|
82.89 score on a scale
Standard Deviation 26.95
|
83.61 score on a scale
Standard Deviation 18.70
|
|
Difficulties in Emotion Regulation Scale
6-month Follow-up
|
81.33 score on a scale
Standard Deviation 24.97
|
82.72 score on a scale
Standard Deviation 19.74
|
SECONDARY outcome
Timeframe: 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).Population: Participants who had complete data for both in-person group sessions. The state ders was administered prior to beginning the first in-person session (i.e., pre-intervention) and at the end of the second session (i.e, post-intervention).
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=28 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=28 Participants
Time and attention control.
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.
|
|---|---|---|
|
State Difficulties in Emotion Regulation Scale
Pre-intervention
|
38.57 score on a scale
Standard Deviation 10.55
|
38.71 score on a scale
Standard Deviation 11.04
|
|
State Difficulties in Emotion Regulation Scale
Post-intervention
|
35.79 score on a scale
Standard Deviation 11.49
|
38.04 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Assessed from baseline to the post-intervention survey; From post-intervention to the 3-month follow up; From 3- to 6-month follow upPopulation: Participants who had data for all time points were included in the repeated measures ANOVA.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=26 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=19 Participants
Time and attention control.
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.
|
|---|---|---|
|
The Protective Behavioral Strategies Scale
Baseline
|
58.23 score on a scale
Standard Deviation 10.08
|
55.21 score on a scale
Standard Deviation 10.91
|
|
The Protective Behavioral Strategies Scale
Post-Intervention
|
61.08 score on a scale
Standard Deviation 10.21
|
60.00 score on a scale
Standard Deviation 13.84
|
|
The Protective Behavioral Strategies Scale
3-Month Follow-up
|
61.92 score on a scale
Standard Deviation 13.39
|
62.58 score on a scale
Standard Deviation 12.83
|
|
The Protective Behavioral Strategies Scale
6-Month Follow-up
|
60.92 score on a scale
Standard Deviation 11.73
|
61.53 score on a scale
Standard Deviation 12.69
|
SECONDARY outcome
Timeframe: Assessed at baseline, post-intervention, 3-month follow up, and 6-month follow upPopulation: Analysis included those participants who had complete data on the Dating Behavior Survey at all 4 time points.
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.
Outcome measures
| Measure |
Revictimization Prevention for College Women (RPCW)
n=26 Participants
Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception.
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.
|
Health Education Control (HEC)
n=18 Participants
Time and attention control.
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.
|
|---|---|---|
|
The Dating Self-Protection Against Rape Scale
Baseline
|
50.15 score on a scale
Standard Deviation 8.15
|
55.61 score on a scale
Standard Deviation 14.50
|
|
The Dating Self-Protection Against Rape Scale
Post-intervention
|
46.23 score on a scale
Standard Deviation 8.20
|
52.67 score on a scale
Standard Deviation 9.91
|
|
The Dating Self-Protection Against Rape Scale
3-month follow-up
|
49.65 score on a scale
Standard Deviation 8.90
|
49.39 score on a scale
Standard Deviation 8.77
|
|
The Dating Self-Protection Against Rape Scale
6-month follow-up
|
47.77 score on a scale
Standard Deviation 7.08
|
51.50 score on a scale
Standard Deviation 8.05
|
Adverse Events
Revictimization Prevention for College Women (RPCW)
Health Education Control (HEC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kathleen Parks
State University of New York at Buffalo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place