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| Name | Class |
|---|---|
| Klein Buendel, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nightlife Safety Plans (NSP) | Experimental | 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. |
|
| Fire Safety | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nightlife Safety Plans (NSP) | Behavioral | A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Legally Intoxicated | Percent who were legally intoxicated (BAC.08% or higher) | 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 Recreational Drug Use |
| Measure | Description | Time Frame |
|---|---|---|
| Experienced Physical Aggression | While at the club, someone intentionally pushed, shoved, or punched the respondent | 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. |
| Experienced Sexual Aggression |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda A Miller, Ph.D. | Pacific Institute for Research and Evaluation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brenda Miller | Berkeley | California | 94704-1365 | United States | ||
| Prevention Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34658404 | Background | Byrnes HF, Miller BA, Bourdeau B, Johnson MB. Impact of Group Cohesion Among Drinking Groups at Nightclubs on Risk From Alcohol and Other Drug Use. J Drug Issues. 2019 Oct;49(4):668-679. doi: 10.1177/0022042619859257. Epub 2019 Sep 8. | |
| 31495379 | Result | Byrnes HF, Miller BA, Bourdeau B, Johnson MB, Buller DB, Berteletti J, Rogers VA. Prevention of Alcohol and Other Drug Overuse Among Nightclub Patrons: A Randomized Trial of a Group-Based Mobile Intervention at Nightclubs. J Stud Alcohol Drugs. 2019 Jul;80(4):423-430. doi: 10.15288/jsad.2019.80.423. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Nightlife Safety Plans | Observed indicators that an individual 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 peer group made before entering the club that they would leave as a group to keep each other safe. 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 peer approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention. |
| FG001 | Fire Safety | Individuals in the control condition were also given information on safety and the focus of this safety message was regarding fires in nightclubs. They were given didactic materials to read with some still images. There were a few questions for the peer group to address. Fire Safety: They were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of cases analyzed is less than the total number who returned for follow-up due to incomplete exit surveys. | Posted | Mean | Standard Deviation | score on a scale | 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. | groups | groups |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Trials were conducted in San Francisco Bay Area thus represent one geographical location
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenda A. Miller | PIRE | 5105205889 | BMiller@prev.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2025 | Jan 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2014 | Jan 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D000435 | Alcoholic Intoxication |
| D000374 | Aggression |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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Randomized Controlled Trial
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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.
| Fire Safety | Behavioral | Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety |
|
Any use of recreational drugs present in oral fluid tests based upon lab results |
| 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. |
| Leaving Club With Friend(s) Arrived With | Prevalence of safety action to leave club with friends that 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. |
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 |
| 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. |
| Sexual Harassment | Respondent experienced someone sexually coming on to person after indicating no interest | 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. |
| Berkeley |
| California |
| 94704 |
| United States |
| NOT COMPLETED |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Legally intoxicated by alcohol | Breath tests using a breathalyzer that resulted in a percent of alcohol in breath that was .05% or higher was considered evidence of alcohol impairment or intoxication. | Breath tests to determine the level of alcohol use was not obtained on all participants due to equipment or recording failure. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. Nightlife 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. |
| OG001 | 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 |
|
|
|
| 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. | Only individuals who had experienced physical aggression could possibly have someone take action to intervene, hence the overall number of participants analyzed is smaller. | Posted | Count of Participants | Participants | 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. |
|
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|
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| 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. | 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. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Legally Intoxicated | Percent who were legally intoxicated (BAC.08% or higher) | 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. | Posted | Count of Participants | Participants | 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. |
|
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| Secondary | Prevalence of Recreational Drug Use | Any use of recreational drugs present in oral fluid tests based upon lab results | 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. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Leaving Club With Friend(s) Arrived With | Prevalence of safety action to leave club with friends that arrived with | Missing data accounts for the lower number of cases in each of the conditions due to not completing the questionnaire. | Posted | Count of Participants | Participants | 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. |
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| Other Pre-specified | Experienced Physical Aggression | While at the club, someone intentionally pushed, shoved, or punched the respondent | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Other Pre-specified | Sexual Harassment | Respondent experienced someone sexually coming on to person after indicating no interest | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 0 |
| 459 |
| 0 |
| 459 |
| 0 |
| 459 |
| EG001 | 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 | 0 | 500 | 0 | 500 | 0 | 500 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D012919 | Social Behavior |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|