Aggression, Aggression Sexual, Drinking, Binge, Drink Too Much, Drug Use, Drunk, Harm Reduction, Peer Group, Safety Issues
Conditions
Keywords
nightclubs, bars, alcohol, drugs, aggression, harm reduction
Brief summary
The purpose of this study is to develop and test a group-based strategy for encouraging groups of young adults who are engaged in party behaviors at nightclubs to intervene with each other to reduce harms associated with overuse of alcohol and recreational drugs and to reduce harms associated with aggression (physical and sexual).
Detailed description
This study focuses on high risk behaviors (excessive alcohol use, drug use) and unwanted experiences (physical/sexual aggression) that may occur during an evening at a night club for young adults engaged in party behaviors. the goals were: 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 for and to provide them with tools to reduce harms. An algorithm calculated in real time during an entrance survey predicted the types of risks that the group members may encounter during the evening based upon past behaviors and expectations for the evening. Social groups in the experimental condition were exposed to a brief intervention that focused on developing skills described as the 3 O's: a) Outreach-how to approach fellow group members who are at risk, (b) Options-how to suggest options that would increase safety and (c) Out-How to assess when it is time to leave the club. This brief, interactive intervention was delivered by small tablet computers that utilized mobile application technology and cellular wireless service. This low cost delivery was considered important to providing later adoption in the real world and the interactive nature of the intervention was designed to appeal to the young adult population.
Interventions
BEHAVIORALNightlife Safety Plans (NSP)
A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
BEHAVIORALFire Safety
Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
Sponsors
Klein Buendel, Inc.
Pacific Institute for Research and Evaluation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protective Action Reported for Sexual Aggression Incident | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported. |
| Number of Safety Actions Taken to Intervene Within Group | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Five types of safety actions were assessed for individuals (as they exited the club) that could have occurred in response to peer's use of alcohol or drugs, experiencing physical aggression and/or sexual aggression. These safety actions were: (1) checked in with friends to assess their safety, (2) monitored alcohol consumption of peers, (3) encouraged peer to pace their drinking, (4) discouraged drug use, and (5) encouraged steps to sober up. An individual could report 0-5 safety actions. Because this was a peer group intervention, a mean score was created for each group by adding the total individual scores within each group, (groups ranged in size from 2-9, making this total possible range 0-45) and dividing these total within group scores by the number in the group. Thus, each peer group had a score ranging from 0-5, with the higher the score, the more protective the group was. |
| Protective Action Reported for Physical Aggression Incident | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Recreational Drug Use | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Any use of recreational drugs present in oral fluid tests based upon lab results |
| Legally Intoxicated | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Percent who were legally intoxicated (BAC.08% or higher) |
| Leaving Club With Friend(s) Arrived With | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Prevalence of safety action to leave club with friends that arrived with |
Other
| Measure | Time frame | Description |
|---|---|---|
| Experienced Physical Aggression | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | While at the club, someone intentionally pushed, shoved, or punched the respondent |
| Sexual Harassment | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | Respondent experienced someone sexually coming on to person after indicating no interest |
| Experienced Sexual Aggression | On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes. | While at the club, the respondent experienced someone touching them sexually in a way that they did not want to be touched or did something else sexual to the respondent that they did not want them to do |
Countries
United States
Participant flow
Recruitment details
Individuals who arrived in Groups (2+ people) were recruited as they were entering the club. Not everyone in the group had to agree to participate to be eligible. No names were collected at recruitment.
Pre-assignment details
Individuals who arrived in Groups (2+ people) were recruited as they were entering the club. Not everyone in the group had to agree to participate to be eligible. No names were collected at recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Nightlife Safety Plans (NSP) 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.
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. | 459 |
| 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.
Fire Safety: Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety | 500 |
| Total | 959 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Withdrawal by Subject | 0 | 3 |
| Follow-up | Lost to Follow-up | 56 | 54 |
Baseline characteristics
| Characteristic | Total | Fire Safety | Nightlife Safety Plans (NSP) |
|---|---|---|---|
| Age, Continuous | 27.99 years STANDARD_DEVIATION 6.35 | 28.31 years STANDARD_DEVIATION 6.56 | 27.63 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 190 Participants | 93 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 709 Participants | 375 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 60 Participants | 32 Participants | 28 Participants |
| Legally intoxicated by alcohol | 256 Participants | 151 Participants | 105 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 203 Participants | 115 Participants | 88 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants | 47 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 67 Participants | 28 Participants | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 16 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 168 Participants | 85 Participants | 83 Participants |
| Race (NIH/OMB) White | 418 Participants | 213 Participants | 205 Participants |
| Region of Enrollment United States | 959 participants | 500 participants | 459 participants |
| Sex/Gender, Customized female | 413 Participants | 218 Participants | 195 Participants |
| Sex/Gender, Customized male | 502 Participants | 255 Participants | 247 Participants |
| Sex/Gender, Customized refused/unidentified | 40 Participants | 25 Participants | 15 Participants |
| Sex/Gender, Customized transgender male | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized transgender woman | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 459 | 0 / 500 |
| other Total, other adverse events | 0 / 459 | 0 / 500 |
| serious Total, serious adverse events | 0 / 459 | 0 / 500 |
Outcome results
Primary
Number of Safety Actions Taken to Intervene Within Group
Five types of safety actions were assessed for individuals (as they exited the club) that could have occurred in response to peer's use of alcohol or drugs, experiencing physical aggression and/or sexual aggression. These safety actions were: (1) checked in with friends to assess their safety, (2) monitored alcohol consumption of peers, (3) encouraged peer to pace their drinking, (4) discouraged drug use, and (5) encouraged steps to sober up. An individual could report 0-5 safety actions. Because this was a peer group intervention, a mean score was created for each group by adding the total individual scores within each group, (groups ranged in size from 2-9, making this total possible range 0-45) and dividing these total within group scores by the number in the group. Thus, each peer group had a score ranging from 0-5, with the higher the score, the more protective the group was.
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nightlife Safety Plans (NSP) | Number of Safety Actions Taken to Intervene Within Group | 2.14 score on a scale | Standard Deviation 0.96 |
| Fire Safety | Number of Safety Actions Taken to Intervene Within Group | 1.90 score on a scale | Standard Deviation 0.85 |
Comparison: The unit of analyses was the individual, nested within groups.p-value: <0.001ANOVA
Primary
Protective Action Reported for Physical Aggression Incident
Among those who experienced physical aggression, the prevalence of a group member taking action(s) to intervene was reported.
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: Only individuals who had experienced physical aggression could possibly have someone take action to intervene, hence the overall number of participants analyzed is smaller.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Protective Action Reported for Physical Aggression Incident | 9 Participants |
| Fire Safety | Protective Action Reported for Physical Aggression Incident | 3 Participants |
p-value: 0.08Chi-squared, Corrected
Primary
Protective Action Reported for Sexual Aggression Incident
Among those who experienced sexual aggression, the prevalence of a group member taking action(s) to intervene was reported.
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: Analyses based upon those who reported an incident of sexual aggression as those who had not experienced sexual aggression would not have received any safety actions from a group member.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Protective Action Reported for Sexual Aggression Incident | 16 Participants |
| Fire Safety | Protective Action Reported for Sexual Aggression Incident | 11 Participants |
p-value: 0.954Chi-squared, Corrected
Secondary
Leaving Club With Friend(s) Arrived With
Prevalence of safety action to leave club with friends that arrived with
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: Missing data accounts for the lower number of cases in each of the conditions due to not completing the questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Leaving Club With Friend(s) Arrived With | 345 Participants |
| Fire Safety | Leaving Club With Friend(s) Arrived With | 342 Participants |
p-value: <0.001Chi-squared, Corrected
Secondary
Legally Intoxicated
Percent who were legally intoxicated (BAC.08% or higher)
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: Legal intoxication was determined by the use of a breath test. The discrepancy between the overall number of participants included at follow-up was lower due to equipment (breathalyzer) data was unable to be linked to a specific person either due to equipment malfunction or human error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Legally Intoxicated | 151 Participants |
| Fire Safety | Legally Intoxicated | 189 Participants |
p-value: 0.035Chi-squared, Corrected
Secondary
Prevalence of Recreational Drug Use
Any use of recreational drugs present in oral fluid tests based upon lab results
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: The population analyzed is smaller than the number or respondents who completed follow-up due to refusals to give oral fluid samples for analyses or human error resulting in inability to link the oral fluid sample with a specific person.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Prevalence of Recreational Drug Use | 141 Participants |
| Fire Safety | Prevalence of Recreational Drug Use | 132 Participants |
p-value: 0.106Chi-squared, Corrected
Other Pre-specified
Experienced Physical Aggression
While at the club, someone intentionally pushed, shoved, or punched the respondent
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Experienced Physical Aggression | 37 Participants |
| Fire Safety | Experienced Physical Aggression | 39 Participants |
Other Pre-specified
Experienced Sexual Aggression
While at the club, the respondent experienced someone touching them sexually in a way that they did not want to be touched or did something else sexual to the respondent that they did not want them to do
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Experienced Sexual Aggression | 52 Participants |
| Fire Safety | Experienced Sexual Aggression | 40 Participants |
Other Pre-specified
Sexual Harassment
Respondent experienced someone sexually coming on to person after indicating no interest
Time frame: On average, follow up data was collected 1 hour and 54 minutes after baseline (SD 1 hour 3 minutes). The range was from 9 minutes to 5 hours and 15 minutes.
Population: The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys and non-response to item.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nightlife Safety Plans (NSP) | Sexual Harassment | 50 Participants |
| Fire Safety | Sexual Harassment | 52 Participants |