Clinical trial NCT03652688: Group-based Intervention for Club Patrons
Official title: Group-based Intervention for Alcohol, Drugs and Aggression Among Club Patrons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drink Too Much
Drinking, Binge
Drunk
Drug Use
Aggression
Aggression Sexual
Peer Group
Safety Issues
Harm Reduction
Keywords: nightclubs
bars
alcohol
drugs
aggression
harm reduction
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
Collaborators: name: Klein Buendel, Inc.
First posted: 2018-08-29
Enrollment: 959
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Must be within age range, entering the club that night, group size must be 2 or more

Exclusion Criteria:

* working or performing at the club that night

Primary outcomes:
measure: Number of Safety Actions Taken to Intervene Within Group
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.
measure: Protective Action Reported for Physical Aggression Incident
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.
measure: Protective Action Reported for Sexual Aggression Incident
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.
Secondary outcomes:
measure: Legally Intoxicated
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.
measure: Prevalence of Recreational Drug Use
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.
measure: Leaving Club With Friend(s) Arrived With
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.
Other outcomes:
measure: Experienced Physical Aggression
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.
measure: Experienced Sexual Aggression
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.
measure: Sexual Harassment
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.
Locations:
city: Berkeley
country: United States
facility: Brenda Miller
state: California
city: Berkeley
country: United States
facility: Prevention Research Center
state: California
Study officials:
affiliation: Pacific Institute for Research and Evaluation
name: Brenda A Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Byrnes HF, Miller BA, Bourdeau B, Johnson MB. Impact of Group Cohesion Among Drinking Groups at Nightclubs on Risk From Alcohol and Other Drug Use. J Drug Issues. 2019 Oct;49(4):668-679. doi: 10.1177/0022042619859257. Epub 2019 Sep 8.
citation: Byrnes HF, Miller BA, Bourdeau B, Johnson MB, Buller DB, Berteletti J, Rogers VA. Prevention of Alcohol and Other Drug Overuse Among Nightclub Patrons: A Randomized Trial of a Group-Based Mobile Intervention at Nightclubs. J Stud Alcohol Drugs. 2019 Jul;80(4):423-430. doi: 10.15288/jsad.2019.80.423.