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Group-based Intervention for Club Patrons

Primary Purpose

Drink Driving, Drink Too Much, Drinking, Binge

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Three 0's
Fire Safety
Sponsored by
Pacific Institute for Research and Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drink Driving focused on measuring clubs

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Three 0's

Fire Safety

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Actions taken to intervene (number) for risks
actions specified in the 0's were taken

Secondary Outcome Measures

Prevalence of any action by individuals for risks
The prevalence of individuals taking action
Prevalence of any action by groups for risks
The prevalence of someone in the group taking action
Alcohol Use measured by BAC
BAC level at exit
Drug Use measured by oral fluid
Prevalence of drug use

Full Information

First Posted
April 16, 2018
Last Updated
August 28, 2018
Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Klein Buendel, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03652688
Brief Title
Group-based Intervention for Club Patrons
Official Title
Group-based Intervention for Alcohol, Drugs and Aggression Among Club Patrons
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2014 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Klein Buendel, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to develop and test a group-based strategy for preventing high risk outcomes for patrons of nightclubs. Outcomes include overuse of alcohol, use of illicit drugs, drinking/drug use and driving (or riding with impaired driver), experiences of physical aggression, and experiences of sexual harassment/aggression. By working with the social group, the investigators use a peer-base approach for reducing high risk problems that can occur in nightclub settings.
Detailed Description
This study focuses on high risk behaviors (excessive alcohol use, drug use, physical and/or sexual aggression, and unsafe exit behaviors-e.g., drinking and driving, riding with a drinking driver) of young adults who patronize clubs. These risk behaviors are prevalent in clubs and drinking establishments. The goals are twofold: 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 to these high risk behaviors and to provide them with tools to protect their members against those risks by being prepared to implement the 3 O's: a) Outreach-approach fellow group members who are at risk, (b) Options-to suggest alternatives that would increase safety and (c) Out-to increase awareness of when it is time to leave. This brief, interactive intervention was delivered by small tablet computers that utilize mobile application technology and cellular wireless service. This will facilitate later adoption in the real world, by offering low cost delivery and engagement of the young adult population. Specific Aim I: To test and reduce the number of screening questions necessary to develop a risk algorithm (to predict our high risk behaviors) for social groups and to test the feasibility of immediate onsite compilation of individual results into a group risk algorithm. To test a brief screener of individual and group indicators obtained at entrance that predict high risk behaviors (excessive alcohol use, drug use, physical and/or sexual aggression, and/or unsafe behaviors after exiting the club). To test the onsite data collection and compilation of group-based risk indicators. To develop a risk algorithm for groups that can be used in Specific Aim II. The risk algorithm will provide an indication of how likely it is that a specific group will experience each of the high risk behaviors. Specific Aim II: To design and test the feasibility of a brief, group-based intervention designed for presentation prior to entering the club and that addresses high risk behaviors while at the clubs. To design a group-based, brief intervention for delivery prior to entry, to reduce high risk behaviors in the club. To determine whether the brief intervention increases awareness of early indicators of risk and increases the use of strategies employed by the social groups in the club. To test the intervention's efficacy to reduce high risk behaviors in the club. To determine the level of satisfaction with the intervention (for intervention condition only).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drink Driving, Drink Too Much, Drinking, Binge, Drunk, Drug Use, Aggression, Aggression Sexual, Peer Group
Keywords
clubs

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
959 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three 0's
Arm Type
Experimental
Arm Description
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.
Arm Title
Fire Safety
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Three 0's
Intervention Description
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
Intervention Name(s)
Fire Safety
Intervention Description
Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
Primary Outcome Measure Information:
Title
Actions taken to intervene (number) for risks
Description
actions specified in the 0's were taken
Time Frame
Measured at exit from club only, up to 5.5 hours later
Secondary Outcome Measure Information:
Title
Prevalence of any action by individuals for risks
Description
The prevalence of individuals taking action
Time Frame
Assessed at exit from club only, up to 5.5 hours later
Title
Prevalence of any action by groups for risks
Description
The prevalence of someone in the group taking action
Time Frame
Assessed at exit from club only, up to 5.5 hours later
Title
Alcohol Use measured by BAC
Description
BAC level at exit
Time Frame
Assessed at entrance and exit from club, up to 5.5 hours later
Title
Drug Use measured by oral fluid
Description
Prevalence of drug use
Time Frame
Assessed at exit from club only, up to 5.5 hours later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda A Miller, Ph.D.
Organizational Affiliation
Pacific Institute for Research and Evaluation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Research Center
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Group-based Intervention for Club Patrons

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