Mindfulness-Based Substance Use Prevention (MINDS-UP) (MINDS-UP)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Prevention Plus Wellness; Behavioral: MINDS-UP; Diagnostic test: fMRI

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David C Saunders, MD, PhD; Phone Number: 914-409-6807; Email: david.saunders@nyspi.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sport: Prevention Plus Wellness (PPW); Sport: Prevention Plus Wellness (PPW) is a brief, evidence-based substance use prevention program for youth. PPW consists of a single remote-delivered 45-minute session by a research assistant (RA) trained in PPW that is interactive and intended for use by youth in the home setting. It involves screening youth to increase awareness of their current health behaviors; motivational enhancement for change; and establishing a behavior goal plan.	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.; Other Names: PPW
Experimental: MINDS-UP with MRI + PPW; MINDS-UP consists of 4 x 60-minute sessions, once weekly over 4 weeks. MINDS-UP will be delivered to participants remotely, in a 1:1 setting, taught by the meditation teachers that will be hired and trained by Dr. Saunders. Additionally, participants will be provided audio files of 5-10-minute guided meditation practices, led by Dr. Saunders, as homework. Half of those randomized to receive MINDS-UP + PPW (n=10) will receive functional and structural MRI before and after MINDS-UP to evaluate feasibility and acceptability of our MRI procedures and study design. Participants randomized to MINDS-UP with MRI arm will also complete PPW.	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.; Other Names: PPW; 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.; Diagnostic test: fMRI; Functional MRI to investigate preliminary neural mechanisms of MINDS-UP
Experimental: MINDS-UP without MRI + PPW; MINDS-UP consists of 4 x 60-minute sessions, once weekly over 4 weeks. MINDS-UP will be delivered to participants remotely, in a 1:1 setting, taught by the meditation teachers that will be hired and trained by Dr. Saunders. Additionally, participants will be provided audio files of 5-10-minute guided meditation practices, led by Dr. Saunders, as homework. Participants randomized to MINDS-UP without MRI arm will also complete PPW.	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.; Other Names: PPW; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teacher Rated Participation	Research Assessment Package for Schools - Teacher Rated	Completion of Study (up to 36 months)
Acceptability	Acceptability of Intervention Measure	Completion of Study (up to 36 months)
Retention	Percent of participants who completed all study procedures among those who were randomized	Completion of Study (up to 36 months)
Attendance	Percent of scheduled sessions that were completed by the participant.	Completion of Study (up to 36 months)
Homework Completion	Percentage of assigned homeworks that were completed by the participant.	Completion of Study (up to 36 months)
Participation (student)	Research Assessment Package for Schools - Student Engagement	Completion of Study (up to 36 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI retention	Percentage of participants randomized to receive MRI that complete both MRIs	Completion of Study (up to 36 months)
Future MRI endorsement	Percentage of participants who endorse willingness to undergo a future research MRI scan	Completion of Study (up to 36 months)
Anxiety and Depression	Pre-assessment to post-assessment (and 6 and 12 month-follow-up) difference in score on the Revised Childhood Anxiety and Depression scale, a 47-item self-report scale that assesses childhood/adolescent anxiety and depression symptoms across six sub-domains.	4-6 weeks, 6 months, and 12 months
Mindfulness	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in score on the Child and Adolescent Mindfulness Measure (CAMM); the CAMM is a 10-item measure of self-reported mindfulness; scores range from 0 to 40, with higher scores indicating higher mindfulness	4-6 weeks, 6 months, and 12 months
Externalizing Problems (parent-report)	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in score on the externalizing problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 33 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of externalizing problems	4-6 weeks, 6 months, and 12 months
Externalizing Problems (self-report)	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in the total score on the externalizing problems subscale on the Youth Self Report, which is comprised of 112 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems	4-6 weeks, 6 months, and 12 months
Total Problems (self-report)	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in the total score on the total problems subscale Youth Self Report; the survey is comprised of 112 items, with individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems	4-6 weeks, 6 months, and 12 months
Total Problems (parent-report)	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in the total score on the total problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 98 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems	4-6 weeks, 6 months, and 12 months
Cannabis Use	Cannabis use as measured by the Marijuana Low-Level Use Measure, a short tool that measures early/first use of cannabis.	4-6 weeks, 6 months, and 12 months
Alcohol sipping	Low-level and early alcohol use as characterized by the iSay Sipping Inventory. This survey characterizes low level and first/early alcohol use, including age at first sip, whether that drink was completed, and behaviors after the first sip.	4-6 weeks, 6 months, and 12 months
Tobacco Use	Tobacco use as measured by Tobacco Low Level Use Measure. This is a short tool that measures number of times used, type of tobacco/nicotine used, duration of use, and frequency of use.	4-6 weeks, 6 months, and 12 months
ADHD Symptoms	Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in score on the externalizing problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 33 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of externalizing problems	4-6 weeks, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Diagnostic Techniques and Procedures; Diagnosis; Population Characteristics; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Health
• Other Study ID Numbers: #Pro00076319; K12DA000357 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No