An interventional study of Nightlife Safety Plans (NSP) and Fire Safety in Drink Too Much, Drinking, Binge and Drunk, sponsored by Pacific Institute for Research and Evaluation. Completed at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Pacific Institute for Research and Evaluation · Not applicable, Interventional, and Prevention
The purpose of this study is to develop and test a group-based strategy for encouraging groups of young adults who are engaged in party behaviors at nightclubs to intervene with each other to reduce harms associated with overuse of alcohol and recreational drugs and to reduce harms associated with aggression (physical and sexual).
This study focuses on high risk behaviors (excessive alcohol use, drug use) and unwanted experiences (physical/sexual aggression) that may occur during an evening at a night club for young adults engaged in party behaviors. the goals were: 1) to develop a screener that accurately assesses a group's level of risk for one specific night of club attendance and based upon this assessment, (2) to provide naturally occurring social groups with the necessary skills to identify vulnerability for and to provide them with tools to reduce harms. An algorithm calculated in real time during an entrance survey predicted the types of risks that the group members may encounter during the evening based upon past behaviors and expectations for the evening. Social groups in the experimental condition were exposed to a brief intervention that focused on developing skills described as the 3 O's: a) Outreach-how to approach fellow group members who are at risk, (b) Options-how to suggest options that would increase safety and (c) Out-How to assess when it is time to leave the club. This brief, interactive intervention was delivered by small tablet computers that utilized mobile application technology and cellular wireless service. This low cost delivery was considered important to providing later adoption in the real world and the interactive nature of the intervention was designed to appeal to the young adult population.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 959 is above the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Pacific Institute for Research and Evaluation is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Nightlife Safety Plans (NSP)
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.
Behavioral: Fire Safety
A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
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
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.
Time frame: 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.
Protective Action Reported for Physical Aggression Incident
Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.
Time frame: 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.
Protective Action Reported for Sexual Aggression Incident
Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.
Time frame: 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.
Legally Intoxicated
Percent who were legally intoxicated (BAC.08% or higher)
Time frame: 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.
Prevalence of Recreational Drug Use
Any use of recreational drugs present in oral fluid tests based upon lab results
Time frame: 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.
Leaving Club With Friend(s) Arrived With
Prevalence of safety action to leave club with friends that arrived with
Time frame: 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.
Experienced Physical Aggression
While at the club, someone intentionally pushed, shoved, or punched the respondent
Time frame: 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.
Experienced Sexual Aggression
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
Time frame: 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.
Sexual Harassment
Respondent experienced someone sexually coming on to person after indicating no interest
Time frame: 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.
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.
| Milestone | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Started | 459 | 500 |
| Completed | 459 | 497 |
| Not completed | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Milestone | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Started | 459 | 497 |
| Completed | 403 | 443 |
| Not completed | 56 | 54 |
| Withdrew: Lost to follow-up | 56 | 54 |
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.
| score on a scale | Nightlife Safety Plans (NSP) | Fire Safety |
|---|---|---|
| Number of Safety Actions Taken to Intervene Within Group | 2.14 ± 0.96 | 1.90 ± 0.85 |
Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Protective Action Reported for Physical Aggression Incident | 9 | 3 |
Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Protective Action Reported for Sexual Aggression Incident | 16 | 11 |
Percent who were legally intoxicated (BAC.08% or higher)
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Legally Intoxicated | 151 | 189 |
Any use of recreational drugs present in oral fluid tests based upon lab results
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Prevalence of Recreational Drug Use | 141 | 132 |
Prevalence of safety action to leave club with friends that arrived with
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Leaving Club With Friend(s) Arrived With | 345 | 342 |
While at the club, someone intentionally pushed, shoved, or punched the respondent
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Experienced Physical Aggression | 37 | 39 |
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
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Experienced Sexual Aggression | 52 | 40 |
Respondent experienced someone sexually coming on to person after indicating no interest
| Participants | Nightlife Safety Plans | Fire Safety |
|---|---|---|
| Sexual Harassment | 50 | 52 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nightlife Safety Plans (NSP) | 0/459 (0%) | 0/459 (0%) | 0/459 (0%) |
| Fire Safety | 0/500 (0%) | 0/500 (0%) | 0/500 (0%) |
| Age, Continuous(years) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| Mean | 27.63 ± 6.10 | 28.31 ± 6.56 | 27.99 ± 6.35 |
| Sex/Gender, Customized(Participants) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| female | 195 | 218 | 413 |
| male | 247 | 255 | 502 |
| transgender woman | 1 | 2 | 3 |
| transgender male | 1 | 0 | 1 |
| refused/unidentified | 15 | 25 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| Hispanic or Latino | 97 | 93 | 190 |
| Not Hispanic or Latino | 334 | 375 | 709 |
| Unknown or Not Reported | 28 | 32 | 60 |
| Race (NIH/OMB)(Participants) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 6 | 12 |
| Asian | 88 | 115 | 203 |
| Native Hawaiian or Other Pacific Islander | 10 | 6 | 16 |
| Black or African American | 28 | 47 | 75 |
| White | 205 | 213 | 418 |
| More than one race | 39 | 28 | 67 |
| Unknown or Not Reported | 83 | 85 | 168 |
| Region of Enrollment(participants) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| United States | 459 | 500 | 959 |
| Legally intoxicated by alcohol(Participants) | Nightlife Safety Plans (NSP) | Fire Safety | Total |
|---|---|---|---|
| Count of participants | 105 | 151 | 256 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2016 to primary completion in Oct 2017, 15 months.
Results were first posted in Jan 2025, 7 years 3 months after primary completion.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pacific Institute for Research and Evaluation