Revolutionizing Normative Re-education: Delivering Enhanced PNF Within a Social Media Inspired Game About College Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,143
- 试验地点
- 2
- 主要终点
- Change from Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
研究概览
简要总结
Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around testing first-year students' perceptions about the attitudes and behaviors of their peers in a variety of campus-relevant domains. Five pilot studies suggest that CampusGANDR will be significantly more effective at correcting students' normative misperceptions and reducing their alcohol use than standard PNF, especially among heavier-drinking students and those with greater exposure to alcohol on social media, and that these larger effects are driven by the significantly decreased psychological reactance experienced by students when viewing feedback as part of a game about college life rather than as part of an alcohol-focused program. The current project seeks to 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site trial, 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use across 12 weeks of gameplay among non-drinking, moderate-drinking, and heavy-drinking students, 3) examine person-level moderators of these effects, and 4) evaluate CampusGANDR engagement and sustainability among students who play voluntarily but are not involved in the randomized controlled trial.
详细描述
Despite concerted efforts, high risk drinking remains a significant problem on college campuses. Further, the transition into college is an identified critical period in which risky drinking patterns are often established and serious negative consequences occur. Colleges commonly employ Normative Re-Education (NR), a promising intervention approach focused on correcting over-estimated peer drinking norms, to reduce alcohol risk in first-year students. However, the most cost-effective and scalable NR intervention strategy, web-based personalized normative feedback (PNF), has yielded only modest reductions in drinking. Several issues have been identified that may explain these relatively small effects. For example, students often question the credibility of the normative data, the content fails to capture students' attention, and heavy drinkers often react to feedback defensively. These issues are not surprising as, unlike social media and digital gaming applications that capture and sustain young adults' attention, web-based PNF formats lack the sophisticated digital graphics, social interactivity, and other dynamic features to which students have become accustomed. Further, colleges often make participation mandatory or offer incentives to enroll students in current interventions, likely a detriment to student motivation and thus intervention effectiveness. CampusGANDR (Gamified Alcohol Norm Discovery and Re-education) addresses these issues by delivering alcohol PNF within a fun, gamified smartphone app that tests first-year students' perceptions of college life and classmates' attitudes and behaviors on a weekly basis across the first semester of college. Integrating features from popular social media platforms and evidence-based digital game mechanics (e.g., co-presence, a wager-based system of points, and chance-based uncertainty), CampusGANDR also features enhanced PNF and includes several novel features informed by longstanding cognitive and social psychological theories.
Based on extensive pilot work, the current proposal seeks to: 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site randomized controlled trial (RCT); 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use among students who differ in alcohol use (non-drinkers, light to moderate drinkers, and heavy drinkers); 3) examine person-level moderators of intervention efficacy; and 4) evaluate CampusGANDR engagement and the sustainability of play among students who use the app but aren't recruited into the evaluation study (RCT).
Incoming first-year students at colleges and universities in California (Loyola Marymount University site) and Texas (University of Houston site) consecutive cohorts of first-year students will be invited to download the CampusGANDR app to test their perceptions of campus life compete against their classmates. Then, among students already playing CampusGANDR, a balanced sub-sample of 1,800 non-drinking, light/moderate drinking, and heavy drinking students will be invited to take part in an evaluation study (RCT). Study participants will play CampusGANDR over the initial 12 weeks of the fall semester and complete 4 surveys assessing their alcohol use, social media use, health behaviors, mental health, and adjustment to college. Study participants will be discretely randomized to receive alcohol feedback 0%, 33%, or 67% of weekly CampusGANDR rounds through a backend manipulation of chance elements. Students not meeting study eligibility criteria and those not electing to take part in the evaluation study will still take part in CampusGANDR. The dosage of alcohol feedback among these non-RCT players receive will be determined at random and their app usage data will be employed to assess app engagement and sustainability of play in the absence of study incentives. This project aims to culminate in a highly engaging, scalable, cutting-edge native smartphone app (IOS, Android) able to dynamically tailor the dosage of alcohol feedback delivered based on students' alcohol experience at the point of matriculation.
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
- Single (Participant)
盲法说明
Intervention condition is randomly assigned and the intervention delivery is digital, through a smartphone app. Senior members of the research team will have a record of the participants randomized to each condition but the delivery of all intervention content is automated within the mobile app. Junior members of the research team responsible for tracking participants and sending follow-up survey reminders will not be aware of participant condition assignment.
入排标准
- 年龄范围
- 18 Years 至 20 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To play CampusGANDR individuals must:
- •Have access to either a smartphone or a computer with internet capabilities on which the app can be accessed
- •Be at least 18 years of age and currently enrolled as an incoming first-year student at a college or university in California or Texas.
- •Accept CampusGANDR Terms of Service & Privacy Policy.
- •Additional RCT Inclusion Criteria
- •To take part in the evaluation study participants must:
- •Be a CampusGANDR user between 18 and 20 years old
- •Answer screening questions and screen into an open stratum
- •Review and accept the evaluation study Informed Consent form
排除标准
- •Not meeting inclusion criteria
- •Unwillingness to participate (indicated by failure to accept Terms of Service & Privacy Policy, or provide informed consent)
研究组 & 干预措施
Control PNF
Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
干预措施: Gamified Personalized Normative Feedback (Behavioral)
Light Dose of Alcohol PNF
Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
干预措施: Gamified Personalized Normative Feedback (Behavioral)
Heavy Dose of Alcohol PNF
Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
干预措施: Gamified Personalized Normative Feedback (Behavioral)
结局指标
主要结局
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
时间窗: baseline, 4 months
Assesses frequency and quantity of alcohol consumption over the past month
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
时间窗: baseline, 12 months
Assesses frequency and quantity of alcohol consumption over the past month
Change from Baseline Daily Drinking at 9 Months
时间窗: baseline, 9 months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Alcohol Consequences at 4 Months
时间窗: baseline, 4 months
Assesses experience of negative alcohol outcomes
Change from Baseline Daily Drinking at 4 Months
时间窗: baseline, 4 months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Alcohol Consequences at 9 Months
时间窗: baseline, 9 months
Assesses experience of negative alcohol outcomes
Change from Baseline Daily Drinking at 12 Months
时间窗: baseline, 12 months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Alcohol Consequences at 12 Months
时间窗: baseline, 12 months
Assesses experience of negative alcohol outcomes
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
时间窗: baseline, 9 months
Assesses frequency and quantity of alcohol consumption over the past month
Change From Baseline Daily Drinking at 4 Months
时间窗: baseline, 4 months
The Daily Drinking Questionnaire assessess the number of drinks consumed per week in a typical week over the past three months.
Change From Baseline Daily Drinking at 9 Months
时间窗: baseline, 9 months
The Daily Drinking Questionnaire assesses the number of drinks consumed per week in a typical week over the past three months.
Change From Baseline Daily Drinking at 12 Months
时间窗: baseline, 12 months
Assesses number of drinks consumed during an average week over the past month
Change From Baseline Alcohol Consequences at 4 Months
时间窗: baseline, 4 months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Change From Baseline Alcohol Consequences at 9 Months
时间窗: baseline, 9 months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Change From Baseline Alcohol Consequences at 12 Months
时间窗: baseline, 12 months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
时间窗: baseline, 4 months
We used the Quantity/Frequency/Peak Alcohol measure to assess peak drinks. Participants reported the largest number of drinks they consumed on one occasion in the past 30 days.
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
时间窗: baseline, 9 months
Assesses frequency and quantity of alcohol consumption over the past month
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
时间窗: baseline, 12 months
Assesses frequency and quantity of alcohol consumption over the past month
次要结局
- Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months(baseline, 4 months)
- Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months(baseline, 9 months)
- Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months(baseline, 4 months)
- Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months(baseline, 9 months)
- Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 4 Months(baseline, 4 months)
- Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months(baseline, 12 months)
- Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months(baseline, 12 months)
- Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 9 Months(baseline, 9 months)
- Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 12 Months(baseline, 12 months)
- Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months(baseline, 4 months)
- Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months(baseline, 9 months)
- Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months(baseline, 12 months)
- Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months(baseline, 4 months)
- Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months(baseline, 9 months)
- Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months(baseline, 12 months)
- Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 4 Months(baseline, 4 months)
- Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 9 Months(baseline, 9 months)
- Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 12 Months(baseline, 12 months)