MiREA-AC for Reducing Problematic Alcohol and Marijuana Use in College Students
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsormHealth Systems Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
College student, alcohol consumption in past 90 days
Disqualifiers
non-college student, no alcohol use in the past 90 days
Trial design
Design model
Single group
Treatments tested in this trial
Motivational Intervention Reduction through Ecological Application (MiREA-A). MiREA-AC-- the expanded MiREA-A,
BehavioralMiREA-A, is based on Brief Motivational Interventions (BMI) core concepts to bring change in Alcohol \& Cannabis use. It examines why someone uses substances and provides personalized feedback on consumption and consequences, social norms, and challenges. Feedback is designed to reveal discrepancies between students' use and goals.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: experimental arm which received the interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Eligible participants solicited
Number of eligible participants of the study that we reach out to.
Time frame
6 Months2
Enrolled
Number of eligible participants enrolled
Time frame
6 months3
2-week intervention
Number of enrolled participants who complete the 2-week intervention.
Time frame
6 months4
Usability score
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.
Time frame
6 monthsSecondary outcomes
1
Daily alcohol use
Daily alcohol use by Modified Daily Drinking Questionnaire (DDQ),55 during the intervention.DDQ is a 7-item face-valid instrument measuring alcohol consumption. It assesses alcohol patterns, including quantity, frequency of use, and peak drinking events, on a daily basis over a typical week; these are then averaged over the past month. DDQ has been modified to collect descriptive demographic information, including gender, race/ethnicity, and age. The mean number of drinks per week is calculated by multiplying the amount by the frequency of drinking. The DDQ has been validated for use with college students.
Time frame
6 months2
Alcohol disorders identification
Alcohol Use Disorders Identification Test (AUDIT-C)52,53,54 at baseline, 2-week, and 6-week.Description: AUDIT is a three-question screen used to identify alcohol misuse. It is scored on a scale of 0-12 points (scores of 0 reflect no alcohol use in the past year). The AUDIT-C has performed better than the AUDIT and CAGE screen in identifying heavy drinkers who might benefit from brief interventions56 and it has been validated among college students as a screening tool.49,50 An AUDIT-C cutoff score of 4 or greater demonstrated a sensitivity of 92.6% and a specificity of 86.3% in detecting risky drinkers among college students.
Time frame
6 months3
Alcohol consequences
Alcohol consequences will be assessed by the B-YAACQ at baseline, 2-week, and 6-week.The B-YAACQ will be used to assess the results of the past month's alcohol consequences at each time point. This is a 24-question screen used to identify alcohol consequences. Outcome scores range from 0 to 24. The 30-day B-YAACQ has demonstrated high internal consistency (alpha=.89) for evaluating changes in alcohol consequences.
Time frame
6 months4
Alcohol Consequence Questionnaire
Brief Young Adult Alcohol Consequence Questionnaire (B-YAACQ) at baseline, 2-week, and 6-week.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
mHealth Systems Inc.
Lead sponsor
Boston Children's Hospital
Collaborator
University of North Carolina, Charlotte
Collaborator
Source ClinicalTrials.gov