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Group-based Intervention for Club Patrons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652688
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Klein Buendel, Inc.
Information provided by (Responsible Party):
Brenda Miller, Pacific Institute for Research and Evaluation

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.

Condition or disease Intervention/treatment Phase
Drink Driving Drink Too Much Drinking, Binge Drunk Drug Use Aggression Aggression Sexual Peer Group Behavioral: Three 0's Behavioral: Fire Safety Not Applicable

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.

  1. 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).
  2. To test the onsite data collection and compilation of group-based risk indicators.
  3. 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.

  1. To design a group-based, brief intervention for delivery prior to entry, to reduce high risk behaviors in the club.
  2. 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.
  3. To test the intervention's efficacy to reduce high risk behaviors in the club.
  4. To determine the level of satisfaction with the intervention (for intervention condition only).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 959 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (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.
Primary Purpose: Prevention
Official Title: Group-based Intervention for Alcohol, Drugs and Aggression Among Club Patrons
Actual Study Start Date : July 15, 2014
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Arm Intervention/treatment
Experimental: Three 0's
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: Three 0's
A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.

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.
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




Primary Outcome Measures :
  1. Actions taken to intervene (number) for risks [ Time Frame: Measured at exit from club only, up to 5.5 hours later ]
    actions specified in the 0's were taken


Secondary Outcome Measures :
  1. Prevalence of any action by individuals for risks [ Time Frame: Assessed at exit from club only, up to 5.5 hours later ]
    The prevalence of individuals taking action

  2. Prevalence of any action by groups for risks [ Time Frame: Assessed at exit from club only, up to 5.5 hours later ]
    The prevalence of someone in the group taking action

  3. Alcohol Use measured by BAC [ Time Frame: Assessed at entrance and exit from club, up to 5.5 hours later ]
    BAC level at exit

  4. Drug Use measured by oral fluid [ Time Frame: Assessed at exit from club only, up to 5.5 hours later ]
    Prevalence of drug use



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652688


Locations
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United States, California
Prevention Research Center
Oakland, California, United States, 94612
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Klein Buendel, Inc.
Investigators
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Principal Investigator: Brenda A Miller, Ph.D. Pacific Institute for Research and Evaluation

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Responsible Party: Brenda Miller, Senior Scientist, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT03652688    
Other Study ID Numbers: AA022331
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brenda Miller, Pacific Institute for Research and Evaluation:
clubs
Additional relevant MeSH terms:
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Binge Drinking
Aggression
Behavioral Symptoms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders