An interventional study of MINDS-UP and Prevention Plus Wellness in Substance Use, sponsored by New York State Psychiatric Institute. Not yet recruiting. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Prevention
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 aims of the study are:
Aim 1: Determine feasibility and acceptability of MINDS-UP as a preventive intervention via a) retention, b) attendance, c) teacher-rated participation, d) student-rated participation, e) homework completion, and f) acceptability.
Aim 2: Evaluate neuropsychological mechanisms (target engagement) of MINDS-UP.
Aim 3 (Exploratory): Assess preliminary efficacy of MINDS-UP on substance use initiation (SUI).
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 40 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. The youth 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.
Sport: Prevention Plus Wellness (PPW) is a brief, evidence-based substance use prevention program for youth. PPW consists of a single self-administered 45-minute session 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
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 will also complete PPW, a 45 minute, self-administered course.
Behavioral: MINDS-UP · Behavioral: Prevention Plus Wellness
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.
PPW is a standardized, empirically-based intervention for substance use prevention in adolescents ages 10-14. It consists of 1 45 minute self-administered online course.
Also known as: PPW
Retention
Percent of participants who completed all study procedures among those who were randomized
Time frame: Completion of Study (up to 36 months)
Attendance
Percent of scheduled sessions that were completed by the participant.
Time frame: Completion of Study (up to 36 months)
Teacher Rated Participation
Research Assessment Package for Schools - Teacher Rated
Time frame: Completion of Study (up to 36 months)
Student-Rated Participation
Research Assessment Package for Schools - Student Engagement
Time frame: Completion of Study (up to 36 months)
Homework Completion
Percentage of assigned homeworks that were completed by the participant.
Time frame: Completion of Study (up to 36 months)
Acceptability
Acceptability of Intervention Measure
Time frame: Completion of Study (up to 36 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
Time frame: 4-8 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 ADHD Rating Scale, an 18-item parent-report assessment that measures adolescent behaviors related to ADHD (inattentiveness, hyperactivity).
Time frame: 4-6 weeks, 6 months, and 12 months
Suicidal Thoughts/Behaviors
The C-SSRS is a gold-standard assessment tool for suicide risk. This tool will be administered at every visit.
Time frame: 4-6 weeks, 6 months, 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.
Time frame: 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.
Time frame: 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.
Time frame: 4-6 weeks, 6 months, and 12 months
Total Problems (adolescent report)
The Youth Self Report (YSR) is the self-report adolescent version of the Child Behavior Checklist, and is used to assess emotional and behavioral problems in children and adolescents.
Time frame: 4-6 weeks, 6 months, 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
Time frame: 4-6 weeks, 6 months, and 12 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.
Time frame: 4-6 weeks, 6 months, and 12 months
Perceived Tolerance of Use
The Perceived Tolerance of Use is a tool that assesses peer tolerance of use of substance use (of substances that a participant has heard of, meaning the number of items is variable). It is a tool that is used in the ABCD study and the Monitoring the Future Study, the two most comprehensive studies of adolescent substance use.
Time frame: baseline
Perceived Harm of Substance Use
The Perceived Harm of Substance Use tool assesses perceived harm of substance use (of substances that a participant has heard of, meaning the number of items is variable). It is used in the ABCD study and the Monitoring the Future Study, the two most comprehensive studies of adolescent substance use.
Time frame: baseline
Beliefs About Alcohol Effects
The Brief Comprehensive Effects of Alcohol Questionnaire is a 15-item self-report version of the Comprehensive Effects of Alcohol Questionnaire that is used by the ABCD study to assess an adolescent's expectations of using alcohol.
Time frame: baseline
Beliefs About Smoking Effects
The Adolescent Smoking Consequences Questionnaire (ASCQ) is a 30-item self-report instrument used to assess outcome expectancies of cigarette smoking among adolescents.
Time frame: baseline
Beliefs About Cannabis Effects
Brief -Marijuana Effect Expectancies Questionnaire (MEEQ-B) is a 6-item self-report assessment of an adolescent's expected effect of marijuana.
Time frame: baseline
Risk and Protective Factors
The Community Risk and Protective Factors Survey is a 24-item parent-report tool to assess adolescent's experience of exposure to substance use risk and protective factors in the community.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 15 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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