- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652688
Group-based Intervention for Club Patrons
January 9, 2025 updated by: Brenda Miller, Pacific Institute for Research and Evaluation
Group-based Intervention for Alcohol, Drugs and Aggression Among Club Patrons
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
959
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Berkeley, California, United States, 94704
- Prevention Research Center
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Berkeley, California, United States, 94704-1365
- Brenda Miller
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: 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.
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Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
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Experimental: 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.
|
A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub.
The focus was on peer-to-peer intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Safety Actions Taken to Intervene Within Group
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.
|
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.
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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
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.
|
Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.
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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
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.
|
Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Legally Intoxicated
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.
|
Percent who were legally intoxicated (BAC.08% or higher)
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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.
|
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Prevalence of Recreational Drug Use
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.
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Any use of recreational drugs present in oral fluid tests based upon lab results
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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.
|
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Leaving Club With Friend(s) 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.
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Prevalence of safety action to leave club with friends that arrived with
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experienced Physical Aggression
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.
|
While at the club, someone intentionally pushed, shoved, or punched the respondent
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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.
|
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Experienced Sexual Aggression
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.
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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
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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.
|
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Sexual Harassment
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.
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Respondent experienced someone sexually coming on to person after indicating no interest
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Brenda A Miller, Ph.D., Pacific Institute for Research and Evaluation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
April 16, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 9, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA022331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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