NCT03652688

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
959

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

April 16, 2018

Results QC Date

April 28, 2022

Last Update Submit

January 9, 2025

Conditions

Keywords

nightclubsbarsalcoholdrugsaggressionharm reduction

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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 (3)

  • Legally Intoxicated

    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

    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

    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 (3)

  • Experienced Physical Aggression

    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

    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

    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.

Study Arms (2)

Nightlife Safety Plans (NSP)

EXPERIMENTAL

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)

Fire Safety

SHAM COMPARATOR

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

Interventions

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

Nightlife Safety Plans (NSP)
Fire SafetyBEHAVIORAL

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

Fire Safety

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • working or performing at the club that night

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brenda Miller

Berkeley, California, 94704-1365, United States

Location

Prevention Research Center

Berkeley, California, 94704, United States

Location

Related Publications (2)

  • 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.

    PMID: 34658404BACKGROUND
  • 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.

MeSH Terms

Conditions

Binge DrinkingAlcoholic IntoxicationAggressionHarm Reduction

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsSocial Behavior

Limitations and Caveats

Trials were conducted in San Francisco Bay Area thus represent one geographical location

Results Point of Contact

Title
Dr. Brenda A. Miller
Organization
PIRE

Study Officials

  • Brenda A Miller, Ph.D.

    Pacific Institute for Research and Evaluation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Groups assigned to experimental and control conditions were given a tablet on which either the experimental or control program was provided. Both groups were told that they would be viewing a program on safety while at the club. Both groups had to respond to some questions on the tablet about the program. Both groups were asked to interact as a group to answer these questions. Without a view of the tablet, it appeared as if both experimental and controls had the same condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

April 16, 2018

First Posted

August 29, 2018

Study Start

June 15, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations