Group-based Intervention for Club Patrons

Drug Use Clinical Trial

Official title:

Group-based Intervention for Alcohol, Drugs and Aggression Among Club Patrons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652688
• Other study ID #: AA022331
• Status: Completed
• Phase: N/A
• Start date: July 15, 2014
• Est. completion date: October 30, 2017

Study information

• Verified date: August 2018
• Source: Pacific Institute for Research and Evaluation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggression Sexual
• Binge Drinking
• Drink Driving
• Drink Too Much
• Drinking, Binge
• Drug Use
• Drunk
• Peer Group

Intervention

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

Locations

Country	Name	City	State
United States	Prevention Research Center	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Pacific Institute for Research and Evaluation	Klein Buendel, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actions taken to intervene (number) for risks	actions specified in the 0's were taken	Measured at exit from club only, up to 5.5 hours later
Secondary	Prevalence of any action by individuals for risks	The prevalence of individuals taking action	Assessed at exit from club only, up to 5.5 hours later
Secondary	Prevalence of any action by groups for risks	The prevalence of someone in the group taking action	Assessed at exit from club only, up to 5.5 hours later
Secondary	Alcohol Use measured by BAC	BAC level at exit	Assessed at entrance and exit from club, up to 5.5 hours later
Secondary	Drug Use measured by oral fluid	Prevalence of drug use	Assessed at exit from club only, up to 5.5 hours later