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Mindfulness-Based Substance Use Prevention (MINDS-UP)

NCT06593470 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-24

No results posted yet for this study

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

Conditions

  • Substance Use

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-01-01
Completion
2028-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593470 on ClinicalTrials.gov