Trial Outcomes & Findings for Alcohol and Violence Prevention for College Students (NCT NCT04089137)
NCT ID: NCT04089137
Last Updated: 2025-02-05
Results Overview
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
within 2 year recruitment period
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
Control
This is an assessment only control condition.
|
Positive Change (+Change)
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Positive Change (+Change): This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
COMPLETED
|
82
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol and Violence Prevention for College Students
Baseline characteristics by cohort
| Measure |
Control
n=82 Participants
This is an assessment only control condition.
|
Positive Change (+Change)
n=83 Participants
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Positive Change (+Change): This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.5 years
STANDARD_DEVIATION 1.59 • n=99 Participants
|
20.2 years
STANDARD_DEVIATION 1.66 • n=107 Participants
|
20.35 years
STANDARD_DEVIATION 1.62 • n=206 Participants
|
|
Sex/Gender, Customized
Cisgender heterosexual woman
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Cisgender heterosexual man
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sexual or gender minority
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Prefer not to Answer
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
82 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Enrolled in the study before the COVID-19 pandemic
|
38 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 2 year recruitment periodFeasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Outcome measures
| Measure |
Control
n=82 Participants
This is an assessment only control condition.
|
Positive Change (+Change)
n=83 Participants
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Positive Change (+Change): This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
|
|---|---|---|
|
Feasibility of Enrollment and Recruitment
|
82 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: within 3 months of baseline participationFeasibility of retention was assessed by the number of participants retained in the study
Outcome measures
| Measure |
Control
n=82 Participants
This is an assessment only control condition.
|
Positive Change (+Change)
n=83 Participants
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Positive Change (+Change): This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
|
|---|---|---|
|
Feasibility of Retention
|
71 Participants
|
70 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Change (+Change)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place