Group-based Intervention for Club Patrons

NCT ID: NCT03652688

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 959 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2017-10-01

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.

Conditions

Drink Too Much; Drinking, Binge; Drunk; Drug Use; Aggression; Aggression Sexual; Peer Group; Safety Issues; Harm Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Nightlife Safety Plans (NSP)

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.

Group Type: EXPERIMENTAL

Nightlife Safety Plans (NSP)

Intervention Type: BEHAVIORAL

A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.

Fire Safety

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.

Group Type: SHAM_COMPARATOR

Fire Safety

Intervention Type: BEHAVIORAL

Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety

Interventions

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.

Intervention Type: BEHAVIORAL

Fire Safety

Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klein Buendel, Inc.

INDUSTRY

Sponsor Role: collaborator

Pacific Institute for Research and Evaluation

OTHER

Sponsor Role: lead

Responsible Party

Brenda Miller

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenda A Miller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pacific Institute for Research and Evaluation

Locations

Brenda Miller

Berkeley, California, United States

Prevention Research Center

Berkeley, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34658404 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31495379 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AA022331

Identifier Type: -

Identifier Source: org_study_id