Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 667
- 试验地点
- 2
- 主要终点
- Bystander behavior
研究概览
简要总结
Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •identify as a man or transgender man, age (21-25)
- •consume weight-based amount of alcohol at least three times during the past year
排除标准
- •weight over 250 pounds
- •current treatment-seeking for an alcohol use disorder
- •any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration.
- •in a relationship over 6 months
- •married/living together
- •Neurological Disorder: diagnosis of a neurological disorder
- •Psychiatric Disorder: past or current diagnosis of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, or any other psychotic disorder
- •Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use
- •Physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)
- •Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)
- •Cardiac Pacemaker
- •Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year;
- •Legal: any legal restrictions against drinking (e.g., as a condition of probation or parole)
- •Alcohol Abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year
- •Head Injury: any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
- •Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory
研究组 & 干预措施
Stress Management with Placebo
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
干预措施: No-Alcohol Placebo (Behavioral)
RealConsent 1.0 with Alcohol
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target breath alcohol concentration (BrAC=.08).
干预措施: RealConsent1.0 (Behavioral)
RealConsent 1.0 with Alcohol
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target breath alcohol concentration (BrAC=.08).
干预措施: Alcohol intoxication (Behavioral)
RealConsent 1.0 with Placebo
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
干预措施: RealConsent1.0 (Behavioral)
RealConsent 1.0 with Placebo
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
干预措施: No-Alcohol Placebo (Behavioral)
RealConsent2.0 with Alcohol
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target BrAC=.08).
干预措施: RealConsent2.0 (Behavioral)
RealConsent2.0 with Alcohol
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target BrAC=.08).
干预措施: Alcohol intoxication (Behavioral)
RealConsent2.0 with Placebo
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
干预措施: RealConsent2.0 (Behavioral)
RealConsent2.0 with Placebo
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
干预措施: No-Alcohol Placebo (Behavioral)
Stress Management with Alcohol
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
干预措施: Stress Management (Behavioral)
Stress Management with Alcohol
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
干预措施: Alcohol intoxication (Behavioral)
Stress Management with Placebo
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
干预措施: Stress Management (Behavioral)
结局指标
主要结局
Bystander behavior
时间窗: One-month post-intervention
Bystander behavior will be assessed by a virtual reality (VR) environment titled, Bystanders in Sexual Assault Virtual Environments (B-SAVE). Participants experience a virtual "house party" and are exposed to 5 situations in which they can either intervene or not. Participants are prompted at two points (with a flashing microphone icon) to verbalize their response in that situation - thus providing 10 opportunities to intervene in sexual risk situations. Verbal responses to each situation are recorded and coded to assess for bystander behavior.
Self-Reported Bystander Behavior
时间窗: Change from Baseline at 12-months
The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no).
Self-Reported Bystander Behavior
时间窗: Change from Baseline at 6-months
The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no).
次要结局
- Bystander Efficacy Scale(Change from Baseline at 12-months)
- Barriers to Sexual Assault Bystander Intervention(Change from Baseline at 12-months)
- Sexual Violence Perpetration(Change from Baseline at 12-months)
- Outcome Expectancies for Intervening(Change from Baseline at 12-months)
- Bystander Attitude Scale(Change from Baseline at 12-months)
- Barriers to Sexual Assault Bystander Intervention(Change from Baseline at 6-months)
- Outcome Expectancies for Intervening(Change from Baseline at 6-months)
- Bystander Efficacy Scale(Change from Baseline at 6-months)
- Bystander Attitude Scale(Change from Baseline at 6-months)
- Sexual Violence Perpetration(Change from Baseline at 6-months)
研究者
Laura F Salazar
Multiple Principal Investigator
Georgia State University