Group-based Intervention for Club Patrons
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|ClinicalTrials.gov Identifier: NCT03652688|
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||959 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|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.|
|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|
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
- 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
- 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
- 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
- Alcohol Use measured by BAC [ Time Frame: Assessed at entrance and exit from club, up to 5.5 hours later ]BAC level at exit
- Drug Use measured by oral fluid [ Time Frame: Assessed at exit from club only, up to 5.5 hours later ]Prevalence of drug use
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
|United States, California|
|Prevention Research Center|
|Oakland, California, United States, 94612|
|Principal Investigator:||Brenda A Miller, Ph.D.||Pacific Institute for Research and Evaluation|