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临床试验/NCT05098639
NCT05098639Enrolling By Invitation不适用

An Adaptive Mobile Intervention to Increase Safe Drinking Strategies Using Deviance Regulation Theory

University of Central Florida2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
2
主要终点
Protective Behavioral Strategies- Pre-Intervention

研究概览

简要总结

The current project uses a brief mobile intervention, grounded in Deviance Regulation Theory, to deliver in-the-moment messaging meant to increase responsible drinking among college students. Participants receive positive messages about individuals that use responsible drinking behaviors or negative messages about individuals that do not use responsible drinking behaviors. It is hypothesized that these messages delivered at appropriate times will differentially affect use of responsible drinking behaviors as a function of individual beliefs about the prevalence of responsible drinking among peers.

详细描述

College student alcohol use remains a significant public health issue. College students consume alcohol at higher rates than their non-college peers. Though most college students "mature out" of heavy alcohol use by graduation, the consequences resulting from frequent acute intoxication during college can be devastating. Identifying cost effective ways to reduce problematic alcohol use, that can be widely disseminated, remains vitally important. A large body of literature has examined associations between social norms and drinking among college students. Several college drinking interventions have utilized social norms to reduce alcohol use and alcohol-related consequences. However, recent research suggests these interventions may not be as effective as once though. Despite the support for social norms as an etiological basis for heavy drinking, and its implementation in interventions, the operationalization has remained relatively narrow. Social norms interventions have generally not taken broader theoretical perspectives into account. Nor have they been applied much beyond the exclusive focus on quantity and frequency of consumption. The present study addresses these issues by examining the effects of an intervention grounded in Deviance Regulation Theory, meant to increase use of alcohol protective behavioral strategies when drinking. Deviance Regulation Theory posits that individuals will seek to engage in behaviors that allow them to standout in positive ways or avoid standing-out in negative ways. Both of these effects are based on the perception of the behavioral norm. Participants are randomly assigned to receive messages that presents individuals who DO use PBS in a positive light, information that presents individuals who DO NOT use PBS in a negative light, or an active control (BASICS). It is hypothesized that among individuals who believe PBS use is uncommon among their peers, positive messages about PBS users will result in increased PBS use, and subsequent decreases in alcohol use and problems. In contrast among individuals who believe PBS use is common among their peers, negative messages about PBS users will result in increased PBS use, and subsequent decreases in alcohol use and alcohol problems. If successful this trial will pave the way for a novel intervention for college students that can be tailored to individual beliefs about PBS use norms and that could be combined with existing interventions for college student drinking.

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

Participants will be unaware of the condition they are in. As the initial session requires a brief individual session using BASICS, DRT, or DRT+BASICS, investigators will be aware of study condition.

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Severe mental illness
  • Under 18 years of age
  • Over 26 years of age
  • Unable to speak English fluently

研究组 & 干预措施

Deviance Regulation Theory+BASICS

Experimental

DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs but also follows the framework of BASICS. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on both descriptive and injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment.

干预措施: Deviance Regulation Theory (DRT) (Behavioral)

Deviance Regulation Theory+BASICS

Experimental

DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs but also follows the framework of BASICS. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on both descriptive and injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment.

干预措施: BASICS (Behavioral)

BASICS

Active Comparator

Participants in the active control will receive a modified single session BASICS. BASICS is a well-documented and empirically supported prevention/intervention program for college student drinkers. BASICS targets heavy drinking students that have experienced or are at an increased risk for a variety of alcohol-related problems linked to college student life. The program is designed to help students make better alcohol-use decisions based on a broader understanding of the risks associated with problem drinking. It enhances motivation to change and promotes the development of skills to moderate drinking. The overall style of the program uses motivational interviewing and emphasizes empathy and non-judgmental interaction. The aims of BASICS are to (1) reduce alcohol consumption and consequences, (2) promote healthier and more responsible choices, and (3) provide information and coping skills.

干预措施: BASICS (Behavioral)

Deviance Regulation Theory

Experimental

DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on the injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment.

干预措施: Deviance Regulation Theory (DRT) (Behavioral)

结局指标

主要结局

Protective Behavioral Strategies- Pre-Intervention

时间窗: Past three months prior to intervention/study

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- Week 3

时间窗: Past 1 week measured-2 weeks post intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- 3 month follow up

时间窗: Past 3 months measured- 12 week post intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- Initial intervention (Week 1)

时间窗: Past week before intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- Week 2

时间窗: Past 1 week measured- 1 week post intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- 6 month follow-up

时间窗: Past 3 months measured- 26 weeks post intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

Protective Behavioral Strategies- Week 4

时间窗: Past 1 week measured-3 weeks post intervention

Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.

次要结局

  • Alcohol-related consequences- Pre-intervention(Past three months prior to intervention/study)
  • Alcohol-related consequences- 3 month follow up(Past 3 months measured- 12 week post intervention)
  • Alcohol use- Initial intervention (Week 1)(Past week before intervention)
  • Alcohol use- Week 4(Past 1 week measured- 3 weeks post intervention)
  • Alcohol use- 3 month follow up(Past 3 months measured- 12 week post intervention)
  • Alcohol-related consequences- Week 2(Past 1 week measured- 1 week post intervention)
  • Alcohol-related consequences- Week 3(Past 1 week measured- 2 week post intervention)
  • Alcohol use- Week 2(Past 1 week measured- 1 week post intervention)
  • Alcohol use- 6 month follow up(Past 3 months measured- 24 week post intervention)
  • Alcohol-related consequences- Initial intervention (Week 1)(Past week before intervention)
  • Alcohol use- Week 3(Past 1 week measured- 2 weeks post intervention)
  • Alcohol-related consequences- Week 4(Past 1 week measured- 3 week post intervention)
  • Alcohol-related consequences- 6 month follow-up(Past 3 months measured- 26 weeks post intervention)
  • Alcohol use- Pre-intervention(Past three months prior to intervention/study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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