Trial Outcomes & Findings for Evaluation of Green Dot a Primary Prevention Intervention (NCT NCT01878097)
NCT ID: NCT01878097
Last Updated: 2019-03-15
Results Overview
Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model. Data will be collected at baseline and annually for 4 years.
COMPLETED
NA
89707 participants
up to 5 years follow up from baseline intervention
2019-03-15
Participant Flow
A total of 89,707 students completed surveys. However, due to anonymous response, it is not possible to know the number of unique students who completed surveys within the study period. Two schools within each of the 13 regions were selected by the Rape Crisis Centers for simple randomization to each condition in this cluster RCT (n=26).
46 demographically similar public high schools were identified as willing participate in the trial. Two schools were excluded by researchers because these were too small (\<100 per grade). Among the remaining 36 schools, two schools within each of the 13 regions were selected and randomized (n=26).
Unit of analysis: High schools
Participant milestones
| Measure |
Green Dot Bystander Training
13 receiving Green Dot intervention
Green Dot Bystander Intevention: Intervention allocated at the school level
|
Control
13 high school receiving no bystander training (no intervention)
|
|---|---|---|
|
Implementation Year 1
STARTED
|
11742 13
|
9866 12
|
|
Baseline
STARTED
|
10725 13
|
10081 13
|
|
Baseline
COMPLETED
|
8228 13
|
8281 13
|
|
Baseline
NOT COMPLETED
|
2497 0
|
1800 0
|
|
Implementation Year 1
COMPLETED
|
8540 13
|
7317 12
|
|
Implementation Year 1
NOT COMPLETED
|
3202 0
|
2549 0
|
|
Implementation Year 2
STARTED
|
11567 13
|
9611 12
|
|
Implementation Year 2
COMPLETED
|
8286 13
|
6770 12
|
|
Implementation Year 2
NOT COMPLETED
|
3281 0
|
2841 0
|
|
Implementation Year 3
STARTED
|
10540 13
|
9750 12
|
|
Implementation Year 3
COMPLETED
|
7046 13
|
6770 12
|
|
Implementation Year 3
NOT COMPLETED
|
3494 0
|
2980 0
|
|
Implementation Year 4
STARTED
|
10585 12
|
9614 12
|
|
Implementation Year 4
COMPLETED
|
6981 12
|
6607 12
|
|
Implementation Year 4
NOT COMPLETED
|
3604 0
|
3007 0
|
Reasons for withdrawal
| Measure |
Green Dot Bystander Training
13 receiving Green Dot intervention
Green Dot Bystander Intevention: Intervention allocated at the school level
|
Control
13 high school receiving no bystander training (no intervention)
|
|---|---|---|
|
Baseline
Surveys not fully completed
|
2497
|
1800
|
|
Implementation Year 1
Surveys not fully completed
|
3202
|
2549
|
|
Implementation Year 2
Surveys not fully completed
|
3281
|
2841
|
|
Implementation Year 3
Surveys not fully completed
|
3494
|
2980
|
|
Implementation Year 4
Surveys not fully completed
|
3604
|
3007
|
Baseline Characteristics
Evaluation of Green Dot a Primary Prevention Intervention
Baseline characteristics by cohort
| Measure |
Green Dot Bystander Training
n=13 Schools
26 high schools: 13 receiving Green Dot intervention and 13 no intervention
Green Dot Bystander Intevention: Intervention allocated at the school level
|
Control Training
n=13 Schools
|
Total
n=26 Schools
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Year in School: First Year
|
31.1 Percentage of Participants per School
STANDARD_DEVIATION 5.54 • n=5 Participants
|
30.37 Percentage of Participants per School
STANDARD_DEVIATION 3.3 • n=7 Participants
|
30.69 Percentage of Participants per School
STANDARD_DEVIATION 4.48 • n=5 Participants
|
|
Age, Customized
Year in School: Sophomore
|
27.99 Percentage of Participants per School
STANDARD_DEVIATION 3.95 • n=5 Participants
|
26.72 Percentage of Participants per School
STANDARD_DEVIATION 3.69 • n=7 Participants
|
27.35 Percentage of Participants per School
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Age, Customized
Year in School: Junior
|
25.2 Percentage of Participants per School
STANDARD_DEVIATION 5.95 • n=5 Participants
|
26.37 Percentage of Participants per School
STANDARD_DEVIATION 4.52 • n=7 Participants
|
25.78 Percentage of Participants per School
STANDARD_DEVIATION 5.21 • n=5 Participants
|
|
Age, Customized
Year in School: Senior
|
15.54 Percentage of Participants per School
STANDARD_DEVIATION 9.94 • n=5 Participants
|
16.45 Percentage of Participants per School
STANDARD_DEVIATION 7.96 • n=7 Participants
|
16 Percentage of Participants per School
STANDARD_DEVIATION 8.83 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
54.56 Percentage of Participants per School
STANDARD_DEVIATION 3.2 • n=5 Participants
|
54.11 Percentage of Participants per School
STANDARD_DEVIATION 2.98 • n=7 Participants
|
54.33 Percentage of Participants per School
STANDARD_DEVIATION 3.04 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
45.44 Percentage of Participants per School
STANDARD_DEVIATION 3.2 • n=5 Participants
|
45.89 Percentage of Participants per School
STANDARD_DEVIATION 2.98 • n=7 Participants
|
45.67 Percentage of Participants per School
STANDARD_DEVIATION 3.04 • n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1.08 Percentage of Participants per School
STANDARD_DEVIATION 0.56 • n=5 Participants
|
1.13 Percentage of Participants per School
STANDARD_DEVIATION 0.27 • n=7 Participants
|
1.11 Percentage of Participants per School
STANDARD_DEVIATION 0.43 • n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1.44 Percentage of Participants per School
STANDARD_DEVIATION 1.59 • n=5 Participants
|
1.2 Percentage of Participants per School
STANDARD_DEVIATION 1.08 • n=7 Participants
|
1.32 Percentage of Participants per School
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8.03 Percentage of Participants per School
STANDARD_DEVIATION 10.77 • n=5 Participants
|
6.47 Percentage of Participants per School
STANDARD_DEVIATION 8.65 • n=7 Participants
|
7.25 Percentage of Participants per School
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino/Latina
|
3.16 Percentage of Participants per School
STANDARD_DEVIATION 2.99 • n=5 Participants
|
1.31 Percentage of Participants per School
STANDARD_DEVIATION 0.92 • n=7 Participants
|
2.23 Percentage of Participants per School
STANDARD_DEVIATION 2.37 • n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
82.51 Percentage of Participants per School
STANDARD_DEVIATION 17.06 • n=5 Participants
|
87.22 Percentage of Participants per School
STANDARD_DEVIATION 11.93 • n=7 Participants
|
84.86 Percentage of Participants per School
STANDARD_DEVIATION 14.62 • n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3.78 Percentage of Participants per School
STANDARD_DEVIATION 3.28 • n=5 Participants
|
2.67 Percentage of Participants per School
STANDARD_DEVIATION 2.21 • n=7 Participants
|
3.23 Percentage of Participants per School
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 years follow up from baseline interventionPopulation: Anonymous survey data collected over 5 years and sorted by intervention. To complete ITT analysis, schools that dropped out were included in analysis using imputed data.
Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model. Data will be collected at baseline and annually for 4 years.
Outcome measures
| Measure |
Green Dot Bystander Training
n=13 Schools
Phase one and two.
|
Control
n=13 Schools
No bystander intervention
|
|---|---|---|
|
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Year 1
|
518 Number of events per school
Interval 430.0 to 605.0
|
420 Number of events per school
Interval 353.0 to 486.0
|
|
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Year 2
|
485 Number of events per school
Interval 406.0 to 563.0
|
472 Number of events per school
Interval 353.0 to 552.0
|
|
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Year 3
|
292 Number of events per school
Interval 218.0 to 365.0
|
459 Number of events per school
Interval 392.0 to 526.0
|
|
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Year 4
|
308 Number of events per school
Interval 224.0 to 392.0
|
370 Number of events per school
Interval 316.0 to 424.0
|
PRIMARY outcome
Timeframe: Data will be collected at baseline and annually for 4 years.Population: anonymous survey data collected over 5 years and sorted by intervention. To keep ITT analysis, all schools were included and data were imputed for schools that dropped out.
Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models. Data will be collected at baseline and annually for 4 years.
Outcome measures
| Measure |
Green Dot Bystander Training
n=13 Schools
Phase one and two.
|
Control
n=13 Schools
No bystander intervention
|
|---|---|---|
|
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Year 1
|
300 Number of events per school
Interval 234.0 to 367.0
|
211 Number of events per school
Interval 160.0 to 262.0
|
|
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Year 2
|
292 Number of events per school
Interval 227.0 to 357.0
|
269 Number of events per school
Interval 218.0 to 320.0
|
|
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Year 3
|
161 Number of events per school
Interval 100.0 to 223.0
|
281 Number of events per school
Interval 215.0 to 348.0
|
|
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Year 4
|
157 Number of events per school
Interval 100.0 to 214.0
|
245 Number of events per school
Interval 193.0 to 297.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Data will be collected at baseline and annually for 4 years.Illinois Rape Myth Acceptance Scale measure students' beliefs about rape which may indicate social norms supporting sexual violence. The scale consists of 22 questions scored 1 -5. Were 1 is "strongly agree" and 5 is "strongly disagree". The higher the cumulative score, the more likely the participant is to accept rape myths. 5-item Acceptance of General Dating Violence Scale was used to measure norms supporting dating violence. Scores will range from 1-6, were the higher the score the more likely the participant was to reject dating violence as normal.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Data will be collected at baseline and annually for 4 years.7 item survey measuring self-reports of students actively engaging their peers in behaviors that may prevent violence. Response options: 0 times, 1-2 times, 3-5 times, 6-9 times, 10 or more times, didn't see or hear someone doing this Above items repeated to measure student observing others doing these behaviors. Data will be presented as the total number of interventions were the bigger the number the more likely the bystander was to intervene on behalf of the victim.
Outcome measures
Outcome data not reported
Adverse Events
GreenDot
Control
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