A Reinforced Mindfulness-Based Intervention to Reduce Problematic Drinking Among Hispanic Emerging Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorFlorida International University
About this trial
This study is a trial to evaluate a mindfulness program designed for Hispanic young adults. Participants will be randomly assigned to one of two groups: (1) an in-person, 8-week mindfulness program (one 1.5-hour session per week at FIU's MMC campus), or (2) an assessment-only control group. Regardless of group assignment. Participants will be asked to complete online surveys at baseline, after an 8-week period, and again one month later. They will also be asked to provide a fingerpick blood sample and have their heart rate and blood pressure measured at four timepoints: baseline, 1 month, 2 months, and 3 months after baseline. Participation will involve up to 16 hours over approximately 14 weeks. This includes time for completing baseline assessments, participating in the 8-week intervention (if assigned), and completing post-program and follow-up assessments. There are no serious risks of participating in this study, but some of the questions during the assessments, interview, or the fingerpick may cause you discomfort. The main benefit from participating in this clinical trial is that participants may experience personal benefits from learning mindfulness techniques.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
self-identified Hispanic,
18-25 years old,
engaged in 2 or more occasions of heavy episodic drinking occasions (HED) (4/5 drinks in one sitting for females/males) during the previous 30-days
actively enrolled FIU student.
Disqualifiers
Five or more binge drinking episodes (5+ drinks in one sitting) in the past 30 days, which averages more than once per week.
Weekly or more frequent use of other substances, including non-prescribed prescription drugs, illegal drugs, inhalants, or synthetic drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Sessions - 8 Week Program
BehavioralA culturally, and developmentally adapted Mindfulness-Based Stress Reduction (MBSR) program for Hispanic (self-identified) emerging adult (EA) participants (ages 18-25 years old) over 8 weeks (1.5 hours/week).
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Mindfulness SessionsExperimental treatment 1 intervention
Group B: Assessments OnlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability
Acceptability of the program will be assessed at post-intervention using a study-developed survey consisting of Likert-scale items (1 = Strongly Disagree to 5 = Strongly Agree). The survey evaluates multiple domains, including appropriateness and relevance, ease of participation and feasibility, engagement and interest, perceived benefit, satisfaction, facilitator feedback, and acceptability of the companion rewards program. Higher scores indicate greater acceptability, and results will be summarized descriptively at the item and domain levels.
Time frame
Post Intervention (within 1 week of completing the program)2
Feasibility - Retention
Retention will be assessed as the proportion of enrolled participants who complete the post- and follow-intervention assessments. Unit of measure: percentage of enrolled participants.
Time frame
Post Intervention (within 1 week of completing the program) and follow-up (1-month post program completion)3
Feasibility - Attendance (intervention group only)
Attendance will be assessed as the average number of sessions attended out of 8 total sessions. Unit of measure: mean number of sessions attended.
Time frame
Baseline through Week 8 (end of intervention)Secondary outcomes
1
Reduction in Heavy Episodic Drinking (PEth)
Change in levels of Phosphatidylethanol (PEth) from baseline to post-intervention and 1-month follow-up.
Time frame
Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)2
Reduction in alcohol consumption (self-report)
Change average number of drinking days
Time frame
Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)3
Change in Perceived Stress
Change in self reported stress using validated instruments in RedCap
Time frame
Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida International University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
UConn Health
Collaborator
Source ClinicalTrials.gov