Group-based Intervention for Club Patrons

• ClinicalTrials.gov Identifier: NCT03652688
• Recruitment Status: Completed
• First Posted: August 29, 2018
• Last Update Posted: August 29, 2018
• Sponsor: Pacific Institute for Research and Evaluation
• Collaborator: Klein Buendel, Inc.
• Information provided by (Responsible Party): Brenda Miller, Pacific Institute for Research and Evaluation

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.

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Prevention Research Center

Oakland, California, United States, 94612

Sponsors and Collaborators

Pacific Institute for Research and Evaluation

Klein Buendel, Inc.

Investigators

• Principal Investigator: Brenda A Miller, Ph.D.; Pacific Institute for Research and Evaluation

More Information

• 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
• Last Update Posted: August 29, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Binge Drinking; Aggression; Behavioral Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Mental Disorders