Norms Re-education to Promote Engagement in Parent-based Interventions: A Type 1 Implementation-effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,040
- 试验地点
- 1
- 主要终点
- Change in High Intensity Drinking from Baseline to 7 Months Post Intervention
研究概览
简要总结
A randomized controlled trial (RCT) will be conducted to evaluate both the short-term and long-term efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Although the current NIAAA-recommended Parent Handbook has shown modest effects, our preliminary work suggests that combining personalized normative feedback (PNF) delivered through a social media-inspired app with psychoeducational content can effectively decrease alcohol-related risk. In this large, multi-site trial with 2,040 first-year students, we will examine the short- and long-term effects of the experimental app-based PNF program (PNF+ PBI) compared to an email-based social norms marketing campaign (SNMC+ PBI), the Parent Handbook (PH+ PBI), and an assessment-only control on alcohol use and consequences (primary outcomes). Parent alcohol approval and communication will also be assessed as potential mediators of intervention effects (secondary outcomes). The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related consequences compared to those whose parents receive PH+ PBI or no intervention. It is also expected that parental approval will be lower and alcohol-related communication will be higher in these two experimental conditions, relative to PH+ PBI and no intervention.
详细描述
A randomized controlled trial (RCT) will be conducted to evaluate the feasibility and efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Incoming first-year students will be invited to complete an online baseline survey during the summer prior to matriculation to assess alcohol use and related behaviors. An automated randomizer embedded in the survey will assign students (and thus their parents) to one of four conditions: an experimental app-based personalized normative feedback program (PNF+ PBI), an email-based social norms marketing campaign (SNMC+ PBI), the NIAAA-recommended Parent Handbook (PH+ PBI), or an assessment-only control group. Parents in the PBI conditions will receive access to their assigned program in July or August (immediately following their students completion of the baseline survey). Students will complete a total of four surveys: the baseline assessment and three follow-up surveys at one month, six months, and twelve months post-matriculation. The researchers hypothesize that students whose parents are assigned to the experimental app-based PNF and email-based SNMC conditions will report lower alcohol use and fewer alcohol-related consequences compared to those whose parents receive the Parent Handbook or no intervention. In addition, it is expected that these experimental conditions will yield lower parental alcohol approval and higher levels of alcohol-related communication, which will serve as potential mediators of the intervention effects.
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)
入排标准
- 年龄范围
- 17 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LMU/Lehigh incoming first-year college student who is17-20 years of age
- •Parent/legal guardian with an email address on file with the university
- •A United States resident
- •Provide informed consent/assent
排除标准
- •Younger than 17 or older than 20 years of age
- •Not an incoming first-year college students at LMU/Lehigh
- •Parent or legal guardian does not have an email address on file with the university
- •Not residents of the United States
- •Did not provide informed consent/assent
研究组 & 干预措施
PNF+ PBI
This intervention involves an interactive app that delivers six personalized normative feedback quizzes. Based on quiz responses, the app provides tailored videos and readings that address parents' misperceptions about student drinking and offer strategies to reduce alcohol-related risks. The app also includes a resource library and generates customized reading lists through the quizzes.
干预措施: PNF+ PBI (Behavioral)
SNMC+ PBI
This intervention consists of a series of six structured communications that present risk-reducing normative facts about alcohol use. Each communication includes a specific tip designed to guide parents in effectively discussing alcohol-related risks and establishing constructive conversations with their student.
干预措施: SNMC+ PBI (Behavioral)
PH+ PBI
This intervention provides a digital version of the Parent Handbook, which contains comprehensive psychoeducational content on alcohol-related risks, effective communication strategies, and practical guidelines for reducing underage drinking. The Handbook is designed to be reviewed at the parent's own pace, offering a thorough resource for managing alcohol-related issues.
干预措施: PH+ PBI (Behavioral)
No Intervention
In the control condition, no parent-based intervention content is provided.
结局指标
主要结局
Change in High Intensity Drinking from Baseline to 7 Months Post Intervention
时间窗: baseline, 7 months
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention
时间窗: baseline, 3 months
Self-reported number of drinks consumed during an average week in the past 30 days.
Change in Baseline Daily Drinking from Baseline to 7 Months Post Intervention
时间窗: baseline, 7 months
Self-reported number of drinks consumed during an average week in the past 30 days.
Change in Baseline Daily Drinking from Baseline to 12 Months Post Intervention
时间窗: baseline, 12 months
Self-reported number of drinks consumed during an average week in the past 30 days.
Change in Peak Drinking from Baseline to 1 Month Post Intervention
时间窗: baseline, 1 month
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Change in High Intensity Drinking from Baseline to 1 Month Post Intervention
时间窗: baseline, 1 month
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Change in Peak Drinking from Baseline to 7 Months Post Intervention
时间窗: baseline, 7 months
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Change in Peak Drinking from Baseline to 12 Months Post Intervention
时间窗: baseline, 12 months
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention
时间窗: baseline, 1 month
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention
时间窗: baseline, 7 months
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention
时间窗: baseline, 12 months
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Change in High Intensity Drinking from Baseline to 12 Months Post Intervention
时间窗: baseline, 12 months
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Change in Alcohol-Related Consequences from Baseline to 1 Month Post Intervention
时间窗: baseline, 1 month
Self-reported number of alcohol-related consequences in the past 30 days.
Change in Alcohol-Related Consequences from Baseline to 7 Months Post Intervention
时间窗: baseline, 7 months
Self-reported number of alcohol-related consequences in the past 30 days.
Change in Alcohol-Related Consequences from Baseline to 12 Months Post Intervention
时间窗: baseline, 12 months
Self-reported number of alcohol-related consequences in the past 30 days.
次要结局
- Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention(baseline, 1 month)
- Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention(baseline, 7 months)
- Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention(baseline, 12 months)
- Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention(baseline, 1 month)
- Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention(baseline, 7 months)
- Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention(baseline, 12 months)