Trial Outcomes & Findings for Group-based Intervention for Club Patrons (NCT NCT03652688)
NCT ID: NCT03652688
Last Updated: 2025-01-14
Results Overview
Five types of safety actions were assessed for individuals (as they exited the club) that could have occurred in response to peer's use of alcohol or drugs, experiencing physical aggression and/or sexual aggression. These safety actions were: (1) checked in with friends to assess their safety, (2) monitored alcohol consumption of peers, (3) encouraged peer to pace their drinking, (4) discouraged drug use, and (5) encouraged steps to sober up. An individual could report 0-5 safety actions. Because this was a peer group intervention, a mean score was created for each group by adding the total individual scores within each group, (groups ranged in size from 2-9, making this total possible range 0-45) and dividing these total within group scores by the number in the group. Thus, each peer group had a score ranging from 0-5, with the higher the score, the more protective the group was.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
959 participants
Primary outcome timeframe
On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Results posted on
2025-01-14
Participant Flow
Individuals who arrived in Groups (2+ people) were recruited as they were entering the club. Not everyone in the group had to agree to participate to be eligible. No names were collected at recruitment.
Individuals who arrived in Groups (2+ people) were recruited as they were entering the club. Not everyone in the group had to agree to participate to be eligible. No names were collected at recruitment.
Unit of analysis: groups
Participant milestones
| Measure |
Nightlife Safety Plans
Observed indicators that an individual may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the peer group made before entering the club that they would leave as a group to keep each other safe. Commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Three 0's: A peer approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
Individuals in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. They were given didactic materials to read with some still images. There were a few questions for the peer group to address.
Fire Safety: They were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Baseline
STARTED
|
459 173
|
500 179
|
|
Baseline
COMPLETED
|
459 173
|
497 179
|
|
Baseline
NOT COMPLETED
|
0 0
|
3 0
|
|
Follow-up
STARTED
|
459 173
|
497 179
|
|
Follow-up
COMPLETED
|
403 156
|
443 164
|
|
Follow-up
NOT COMPLETED
|
56 17
|
54 15
|
Reasons for withdrawal
| Measure |
Nightlife Safety Plans
Observed indicators that an individual may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the peer group made before entering the club that they would leave as a group to keep each other safe. Commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Three 0's: A peer approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
Individuals in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. They were given didactic materials to read with some still images. There were a few questions for the peer group to address.
Fire Safety: They were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Baseline
Withdrawal by Subject
|
0
|
3
|
|
Follow-up
Lost to Follow-up
|
56
|
54
|
Baseline Characteristics
Breath tests to determine the level of alcohol use was not obtained on all participants due to equipment or recording failure.
Baseline characteristics by cohort
| Measure |
Nightlife Safety Plans (NSP)
n=459 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Three 0's: A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=500 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
Total
n=959 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.63 years
STANDARD_DEVIATION 6.10 • n=459 Participants
|
28.31 years
STANDARD_DEVIATION 6.56 • n=500 Participants
|
27.99 years
STANDARD_DEVIATION 6.35 • n=959 Participants
|
|
Sex/Gender, Customized
female
|
195 Participants
n=459 Participants
|
218 Participants
n=500 Participants
|
413 Participants
n=959 Participants
|
|
Sex/Gender, Customized
male
|
247 Participants
n=459 Participants
|
255 Participants
n=500 Participants
|
502 Participants
n=959 Participants
|
|
Sex/Gender, Customized
transgender woman
|
1 Participants
n=459 Participants
|
2 Participants
n=500 Participants
|
3 Participants
n=959 Participants
|
|
Sex/Gender, Customized
transgender male
|
1 Participants
n=459 Participants
|
0 Participants
n=500 Participants
|
1 Participants
n=959 Participants
|
|
Sex/Gender, Customized
refused/unidentified
|
15 Participants
n=459 Participants
|
25 Participants
n=500 Participants
|
40 Participants
n=959 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=459 Participants
|
93 Participants
n=500 Participants
|
190 Participants
n=959 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
334 Participants
n=459 Participants
|
375 Participants
n=500 Participants
|
709 Participants
n=959 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=459 Participants
|
32 Participants
n=500 Participants
|
60 Participants
n=959 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=459 Participants
|
6 Participants
n=500 Participants
|
12 Participants
n=959 Participants
|
|
Race (NIH/OMB)
Asian
|
88 Participants
n=459 Participants
|
115 Participants
n=500 Participants
|
203 Participants
n=959 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=459 Participants
|
6 Participants
n=500 Participants
|
16 Participants
n=959 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=459 Participants
|
47 Participants
n=500 Participants
|
75 Participants
n=959 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=459 Participants
|
213 Participants
n=500 Participants
|
418 Participants
n=959 Participants
|
|
Race (NIH/OMB)
More than one race
|
39 Participants
n=459 Participants
|
28 Participants
n=500 Participants
|
67 Participants
n=959 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
83 Participants
n=459 Participants
|
85 Participants
n=500 Participants
|
168 Participants
n=959 Participants
|
|
Region of Enrollment
United States
|
459 participants
n=459 Participants
|
500 participants
n=500 Participants
|
959 participants
n=959 Participants
|
|
Legally intoxicated by alcohol
|
105 Participants
n=436 Participants • Breath tests to determine the level of alcohol use was not obtained on all participants due to equipment or recording failure.
|
151 Participants
n=479 Participants • Breath tests to determine the level of alcohol use was not obtained on all participants due to equipment or recording failure.
|
256 Participants
n=915 Participants • Breath tests to determine the level of alcohol use was not obtained on all participants due to equipment or recording failure.
|
PRIMARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys.
Five types of safety actions were assessed for individuals (as they exited the club) that could have occurred in response to peer's use of alcohol or drugs, experiencing physical aggression and/or sexual aggression. These safety actions were: (1) checked in with friends to assess their safety, (2) monitored alcohol consumption of peers, (3) encouraged peer to pace their drinking, (4) discouraged drug use, and (5) encouraged steps to sober up. An individual could report 0-5 safety actions. Because this was a peer group intervention, a mean score was created for each group by adding the total individual scores within each group, (groups ranged in size from 2-9, making this total possible range 0-45) and dividing these total within group scores by the number in the group. Thus, each peer group had a score ranging from 0-5, with the higher the score, the more protective the group was.
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=173 groups
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=179 groups
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Number of Safety Actions Taken to Intervene Within Group
|
2.14 score on a scale
Standard Deviation 0.96
|
1.90 score on a scale
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: Only individuals who had experienced physical aggression could possibly have someone take action to intervene, hence the overall number of participants analyzed is smaller.
Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=45 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=34 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Protective Action Reported for Physical Aggression Incident
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: Analyses based upon those who reported an incident of sexual aggression as those who had not experienced sexual aggression would not have received any safety actions from a group member.
Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=45 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=34 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Protective Action Reported for Sexual Aggression Incident
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: Legal intoxication was determined by the use of a breath test. The discrepancy between the overall number of participants included at follow-up was lower due to equipment (breathalyzer) data was unable to be linked to a specific person either due to equipment malfunction or human error.
Percent who were legally intoxicated (BAC.08% or higher)
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=390 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=429 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Legally Intoxicated
|
151 Participants
|
189 Participants
|
SECONDARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: The population analyzed is smaller than the number or respondents who completed follow-up due to refusals to give oral fluid samples for analyses or human error resulting in inability to link the oral fluid sample with a specific person.
Any use of recreational drugs present in oral fluid tests based upon lab results
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=393 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=435 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Prevalence of Recreational Drug Use
|
141 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: Missing data accounts for the lower number of cases in each of the conditions due to not completing the questionnaire.
Prevalence of safety action to leave club with friends that arrived with
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=393 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=435 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Leaving Club With Friend(s) Arrived With
|
345 Participants
|
342 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
While at the club, someone intentionally pushed, shoved, or punched the respondent
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=362 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=406 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Experienced Physical Aggression
|
37 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
While at the club, the respondent experienced someone touching them sexually in a way that they did not want to be touched or did something else sexual to the respondent that they did not want them to do
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=376 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=410 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Experienced Sexual Aggression
|
52 Participants
|
40 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
Respondent experienced someone sexually coming on to person after indicating no interest
Outcome measures
| Measure |
Nightlife Safety Plans (NSP)
n=375 Participants
Observed indicators that a group member may be in trouble due identified risks were provided and if detected, they were given practical skills on implementing the 3 0's: Outreach, Options, and Out. Outreach consisted of techniques for approaching your friend and acquiring more information whether there was a problem. Options were to be employed if problems were confirmed and were designed to provide easy, simple steps to reduce risks and decrease probability of escalation of problems. Out refers to the plans the group made before entering the club that they would leave as a group to keep the group members safe. Group commitment to implement these safety steps was emphasized. Interactive and visually attractive scenes were drawn as graphic images to avoid didactic delivery.
Nightlife Safety Plans (NSP): A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
|
Fire Safety
n=408 Participants
Groups in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. Groups were given didactic materials to read with some still images. There were a few questions for the group to address.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
|
|---|---|---|
|
Sexual Harassment
|
50 Participants
|
52 Participants
|
Adverse Events
Nightlife Safety Plans (NSP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fire Safety
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