Clinical trial NCT06593470: Mindfulness-Based Substance Use Prevention (MINDS-UP)
Official title: Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The main questions it aims to answer are:

1. Is MINDS-UP feasible and what is its preliminary efficacy?
2. Are MRI protocol and procedures feasible?

An additional exploratory question is:

Are there neural and psychopathological mechanisms through which MINDS-UP might work?

Researchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP.

Participants will

* take assessment #1
* have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start
* take assessment #2
* take PPW, a single remote and research assistant-delivered 45-minute session
* take assessment #3
* take assessment #4


Eligibility criteria: Inclusion Criteria:

* Youth is ages 10-14 years on the day of screening \[i.e., does not turn 15 before or on the day of screening\]
* Access to a smart phone, tablet, or computer with Wi-Fi
* English-speaking

Exclusion Criteria:

* Has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder.
* Youth is actively involved in another Boricua Youth Study (BYS)
* Youth's sibling is or has previously been enrolled in MINDS-UP.

Primary outcomes:
measure: Teacher Rated Participation
timeFrame: Completion of Study (up to 36 months)
measure: Acceptability
timeFrame: Completion of Study (up to 36 months)
measure: Retention
timeFrame: Completion of Study (up to 36 months)
measure: Attendance
timeFrame: Completion of Study (up to 36 months)
measure: Homework Completion
timeFrame: Completion of Study (up to 36 months)
measure: Participation (student)
timeFrame: Completion of Study (up to 36 months)
Secondary outcomes:
measure: MRI retention
timeFrame: Completion of Study (up to 36 months)
measure: Future MRI endorsement
timeFrame: Completion of Study (up to 36 months)
measure: Anxiety and Depression
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Mindfulness
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Externalizing Problems (parent-report)
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Externalizing Problems (self-report)
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Total Problems (self-report)
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Total Problems (parent-report)
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Cannabis Use
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Alcohol sipping
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: Tobacco Use
timeFrame: 4-6 weeks, 6 months, and 12 months
measure: ADHD Symptoms
timeFrame: 4-6 weeks, 6 months, and 12 months
Other outcomes:
Locations:
Study officials:
References: