NCT03652688

Group-based Intervention for Club Patrons

Completed NA Results posted Last updated 14 January 2025

What this trial tests

NA trial testing Nightlife Safety Plans (NSP) in Drink Too Much in 959 participants. Completed in 1 October 2017.

Timeline

15 June 2016

Primary endpoint
1 October 2017

1 October 2017

Quick facts

Lead sponsor	Pacific Institute for Research and Evaluation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	959
Start date	15 June 2016
Primary completion	1 October 2017
Estimated completion	1 October 2017
Sites	2 locations across United States

Drugs / interventions tested

• Nightlife Safety Plans (NSP)
• Fire Safety

Conditions studied

• Drink Too Much — all drugs for Drink Too Much →
• Drinking, Binge — all drugs for Drinking, Binge →
• Drunk — all drugs for Drunk →
• Drug Use — all drugs for Drug Use →

Sponsor

Pacific Institute for Research and Evaluation

Who can join

21 and older, any sex, with Drink Too Much or Drinking, Binge. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Safety Actions Taken to Intervene Within Group Primary · 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.

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 in

Group	Value	95% CI
Nightlife Safety Plans (NSP)	2.14	± 0.96
Fire Safety	1.90	± 0.85

Protective Action Reported for Physical Aggression Incident Primary · 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.

Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.

Group	Value	95% CI
Nightlife Safety Plans	9
Fire Safety	3

Protective Action Reported for Sexual Aggression Incident Primary · 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.

Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.

Group	Value	95% CI
Nightlife Safety Plans	16
Fire Safety	11

Legally Intoxicated Secondary · 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.

Percent who were legally intoxicated (BAC.08% or higher)

Group	Value	95% CI
Nightlife Safety Plans	151
Fire Safety	189

Prevalence of Recreational Drug Use Secondary · 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.

Any use of recreational drugs present in oral fluid tests based upon lab results

Group	Value	95% CI
Nightlife Safety Plans	141
Fire Safety	132

Leaving Club With Friend(s) Arrived With Secondary · 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 safety action to leave club with friends that arrived with

Group	Value	95% CI
Nightlife Safety Plans	345
Fire Safety	342

Experienced Physical Aggression Secondary · 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.

While at the club, someone intentionally pushed, shoved, or punched the respondent

Group	Value	95% CI
Nightlife Safety Plans	37
Fire Safety	39

Experienced Sexual Aggression Secondary · 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.

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

Group	Value	95% CI
Nightlife Safety Plans	52
Fire Safety	40

Sexual Harassment Secondary · 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.

Respondent experienced someone sexually coming on to person after indicating no interest

Group	Value	95% CI
Nightlife Safety Plans	50
Fire Safety	52

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prevention of Alcohol and Other Drug Overuse Among Nightclub Patrons: A Randomized Trial of a Group-Based Mobile Intervention at Nightclubs.
   Byrnes HF, Miller BA, Bourdeau B, Johnson MB, et al · · 2019 · cited 7× · PMID 31495379 · DOI 10.15288/jsad.2019.80.423