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临床试验/NCT07339150
NCT07339150招募中不适用

MiREA, a mHealth Intervention to Reduce Health Disparities by Improving Access to Mandated College Students With Problematic Alcohol and Marijuana Use

mHealth Systems Inc.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Eligible participants solicited

研究概览

简要总结

The goal of this STTR Phase I funded study is to address the urgent need for an effective primary prevention approach to the problem of heavy episodic drinking and cannabis misuse among mandated college students. Smartphone app interventions are expanding and can offer accessible, scalable, and cost-effective tools. The study will be used to attune a successful evidence-based mHealth smartphone (SP) application (MiREA-AC) focused on alcohol and Cannabis misuse by college students with enhanced content to promote health-seeking behaviors. To test and disseminate the adapted prototype (MiREA-AC), a multisite pilot trial will be conducted to obtain data on the intervention's usability and feasibility in modifying alcohol and cannabis use.

详细描述

MiREA-A intervention is effective with alcohol. MiREA-AC-- the expanded MiREA-A -- has three new features: (1) cannabis content, (2) enhanced UX/UI interface, and (3) information modules for administrative reporting obligations. The study has two aims, as detailed in the following sections - a pilot trial for feasibility and customer discovery for features refinement, commercialization dissemination, reach, and sustainability.

Aim 1: Determine usability, feasibility, and preliminary efficacy of the MiREA-AC intervention (months 1-12); the study will: a) conduct alpha theater and field testing (months 1-3, n=10) at two U.S. campuses to ensure acceptability of the app's three new features; b) conduct a multi-site pilot feasibility trial (months 3-12, n=50) at six U.S. campuses. Metric 1: MiREA-AC refinement completed. Preliminary pilot feasibility testing was conducted on six U.S. campuses (month 12).

MiREA -AC app is designed to be delivered over two weeks, consistent with the delivery of a two-session in-person BMI. The features are delivered in modules which are activated when they are downloaded to the participants' smartphones. Users can then navigate the nine modules of the app with user-friendly directions. The MiREA app has been expanded to include integrated alcohol and cannabis features (MiREA-AC). The eight integrated features are Intro Video, Daily Log, Virtual Coach, Text Messages, Personalized Feedback, Gaming (Learn More), My Strategies, and Where to Go. Theoretical Framework: MiREA-AC incorporates three main theoretical approaches to reduce alcohol and Cannabis misuse in young adults. EMIs can combine ecological momentary assessment (EMA) with real-time delivery to facilitate change. Motivational Interviewing (used in BMIs) is a conversational approach that guides ambivalent clients toward change. According to the Transtheoretical Model (TTM), a leading theory of health behavior change, there are five stages of change: precontemplation, contemplation, preparation, action, and maintenance. As in the study team's prior work, the IDEAS framework was used to guide MiREA-AC development.

Alpha Testing: Theater testing and field-testing during development (months 1-3) will examine the accuracy and address potential technical issues of the developed app. Ten mandated students will be recruited at two U.S. campuses (UNC Charlotte and USC). After an initial in-person session that orients the student to the study, facilitators will demonstrate and explain the app's features (e.g., coach, personalized feedback, alcohol/cannabis tracking) to participants. Participants will use MiREA-AC for two weeks and then complete brief surveys for their reactions to the smartphone app. The APP usage data will be collected, including how often and how much time each app component is used and any mistakes or errors appearing during their use. The study team will correct the errors and make necessary changes to the app based on students' feedback on the ease of use, helpfulness, and overall satisfaction. Pilot Study Sites: A pilot study will then be implemented to assess feasibility and accessibility (months 3-12). Pilot sites will consist of six public and private colleges with diverse backgrounds. All participate in the National Collegiate Health Association survey, which indicates the frequency of drinking and heavy drinking at their schools are consistent with national findings. The target is to enroll 50 eligible students and retain at least 75% at two weeks.

Pilot Study Eligibility: Inclusion criteria: 18- to 25-year-old college students mandated to programming for alcohol and drug policy violations. Positive screening for alcohol use in the past 90 days. A score ≥ 4 on the Alcohol Use Disorders Identification Test-Alcohol Consumption Questions (AUDIT-C), the recommended maximum for drinking among mandated college students.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • College student, alcohol consumption in past 90 days

排除标准

  • non-college student, no alcohol use in the past 90 days

研究组 & 干预措施

experimental arm which received the intervention

Experimental

experimental arm receives two week dose of the MiREA intervention

干预措施: Motivational Intervention Reduction through Ecological Application (MiREA-A). MiREA-AC-- the expanded MiREA-A, (Behavioral)

结局指标

主要结局

Eligible participants solicited

时间窗: 6 Months

Number of eligible participants of the study that we reach out to.

Enrolled

时间窗: 6 months

Number of eligible participants enrolled

2-week intervention

时间窗: 6 months

Number of enrolled participants who complete the 2-week intervention.

Usability score

时间窗: 6 months

Usability score by a mHealth App Usability Questionnaire (MAUQ)56 at 2-week.The USE 26-item questionnaire is widely used for measuring usefulness and ease of use. Each factor is designed to measure the user satisfaction and ease of learning. It was designed as a 7-point Likert scale questionnaire, where 1 = strongly disagree and 7 = strongly agree. Usability is measured on three dimensions: Usefulness (4 items), Satisfaction (7 items), and Ease of use (15 items). Sample questions include, "I am satisfied with it", "it is useful", "it meets my needs" "it is a pleasure to use "and "I learned to use it quickly.

Satisfactory Survey

时间窗: 6 months

Outcomes of a team-designed satisfactory survey at 2 weeks.

次要结局

  • Daily alcohol use(6 months)
  • Alcohol disorders identification(6 months)
  • Alcohol consequences(6 months)
  • Alcohol Consequence Questionnaire(6 months)
  • Readiness Ruler(6 weeks)
  • Comprehensive effects of Alcohol(6 months)
  • Marijuana consequences(6 months)
  • Marijuana effect expectancies(6 months)

研究者

发起方
mHealth Systems Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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