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Not yet recruiting NCT06593470

Mindfulness-Based Substance Use Prevention (MINDS-UP)

No phase Interventional Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MINDS-UP, Prevention Plus Wellness, fMRI.
Who it may be relevant to
Registry conditions: Substance Use. Basic parameters: 10 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial

Overview

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

Interventions

  • Behavioral MINDS-UP
    MINDS-UP is a substance use prevention program for children/adolescents.It consists of 4 x 60-minute sessions, once weekly over 4 weeks. The four MINDS-UP classes will focus on the following: Mindfulness of Body; Mindfulness of Mind; Mindfulness of Environment/Community; Kindness, Compassion, Joy and Equanimity, respectively.
  • Behavioral Prevention Plus Wellness
    PPW is a standardized, empirically-based intervention for substance use prevention in adolescents ages 10-14. It consists of 1 45-60 minute session between an adolescent and a trained PPW teacher.
  • Diagnostic test fMRI
    Functional MRI to investigate preliminary neural mechanisms of MINDS-UP

Primary outcome measures

  • Teacher Rated Participation [Time frame: Completion of Study (up to 36 months)]
  • Acceptability [Time frame: Completion of Study (up to 36 months)]
  • Retention [Time frame: Completion of Study (up to 36 months)]
  • Attendance [Time frame: Completion of Study (up to 36 months)]
  • Homework Completion [Time frame: Completion of Study (up to 36 months)]
  • Participation (student) [Time frame: Completion of Study (up to 36 months)]
Secondary outcome measures (12)
  • MRI retention [Time frame: Completion of Study (up to 36 months)]
  • Future MRI endorsement [Time frame: Completion of Study (up to 36 months)]
  • Anxiety and Depression [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Mindfulness [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Externalizing Problems (parent-report) [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Externalizing Problems (self-report) [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Total Problems (self-report) [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Total Problems (parent-report) [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Cannabis Use [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Alcohol sipping [Time frame: 4-6 weeks, 6 months, and 12 months]
  • Tobacco Use [Time frame: 4-6 weeks, 6 months, and 12 months]
  • ADHD Symptoms [Time frame: 4-6 weeks, 6 months, and 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06593470 · #Pro00076319 · K12DA000357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗