Description

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.

Pilot Trial Study Design: After enrollment, facilitators (site logistics managers) will build rapport with participants, have them download the MiREA-AC app to their phones, and teach them how to use the app and other APP features. The students will be instructed to use the app for two weeks, during which the participants will receive constant personalized feedback. It is hypothesized that mHealth Systems' real-time "push" technologies will raise students' consciousness and reinforce substance use behavior change.

MiREA-AC Baseline. Eligible students enrolled in the study will use the app to complete baseline questionnaires regarding their substance use history, its consequences, and their demographic characteristics. During the two-week treatment period, APP usage data will be collected, including how often and how much time each module is used and the number of personalized messages sent to them.

Two-Week Visit: Participants will give feedback on the app's usability and acceptability as well as issues related to their alcohol and cannabis use and consequences. Six-Week Follow-up: Participants will be followed up and asked to report the student's alcohol and cannabis use and consequences.

Measures. Primary endpoints for assessing the feasibility of the app include participating rate (the number of enrolled participants/the number of eligible students asked to participate), retention rate (proportion of participants who complete two-week visit), treatment adherence (the frequency and length of each module of the app being used during the treatment). Satisfaction measures include outcomes from a satisfactory survey and the Usefulness, Satisfaction, and Ease of Use questionnaire at the end of the two-week treatment.56 Statistical Plan and Data Analysis: The participation and retention rates will be reported at two weeks and include summary statistics of the intervention adherence data since there is little existing knowledge of the feasibility of mHealth intervention for cannabis use and, therefore no existing golden standard for feasibility. With feedback responses to the satisfactory and USE questionnaire, the potential efficacy of the APP will be explored by comparing the participant's substance usage and consequences between baseline and follow-up.

Aim 2: Examine key customer needs by engaging with a Stakeholders Advisory Board (SAB, n=50, months 1-12) composed of health wellness staff, administrators, and minority representatives from HBCUs and ARC socioeconomically disadvantaged colleges and universities and engage the SAB in the integration of MiREA-AC prototype within their mandated programs. Metric 2: SAB meetings completed (by month 12) with representatives (N=50) from six diverse campuses; summary report of customer needs.