Substance UseMINDS-UPNCT06593470
Mindfulness-Based Substance Use Prevention (MINDS-UP)
A study testing MINDS-UP and Prevention Plus Wellness in people with Substance Use, run by New York State Psychiatric Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- MINDS-UP and Prevention Plus Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth is ages 10-14 years on the day of screening [i.e., does not turn 15 before or on the day of screening]
- Youth has access to a smartphone, tablet, or computer with Wi-Fi
- Youth and parent are English-speaking
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 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.
Read more
Aim 2: Evaluate neuropsychological mechanisms (target engagement) of MINDS-UP.
Aim 3 (Exploratory): Assess preliminary efficacy of MINDS-UP on substance use initiation (SUI).
- Conditions
- Substance Use
- Being tested
- MINDS-UP, Prevention Plus Wellness
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDS-UPBehavioural
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.
Prevention Plus WellnessBehavioural
Also called PPW
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.
| Study group | Role | What they receive |
|---|---|---|
| Sport: Prevention Plus Wellness (PPW) | Active comparator | 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. Receives: Behavioral: Prevention Plus Wellness |
| PPW + MINDS-UP | Experimental | 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. Receives: Behavioral: MINDS-UP; Behavioral: Prevention Plus Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Percent of participants who completed all study procedures among those who were randomized
Measured: Completion of Study (up to 36 months)
Attendance
Percent of scheduled sessions that were completed by the participant.
Measured: Completion of Study (up to 36 months)
Teacher Rated Participation
Research Assessment Package for Schools - Teacher Rated
Measured: Completion of Study (up to 36 months)
Student-Rated Participation
Research Assessment Package for Schools - Student Engagement
Measured: Completion of Study (up to 36 months)
Homework Completion
Percentage of assigned homeworks that were completed by the participant.
Measured: Completion of Study (up to 36 months)
Acceptability
Acceptability of Intervention Measure
Measured: Completion of Study (up to 36 months)
Secondary outcomes (15)
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Saunders, MD PhD, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593470
- Sponsor's protocol ID
- #Pro00076319
- Other IDs
- K12DA000357
- Acronym
- MINDS-UP
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06593470
- Acronym / sponsor ID
- MINDS-UP / #Pro00076319
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sport: Prevention Plus Wellness (PPW) | Active comparator | Behavioral: Prevention Plus WellnessSport: 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. |
| PPW + MINDS-UP | Experimental | Behavioral: MINDS-UP, Behavioral: Prevention Plus WellnessMINDS-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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth is ages 10-14 years on the day of screening [i.e., does not turn 15 before or on the day of screening]
- Youth has access to a smartphone, tablet, or computer with Wi-Fi
- Youth and parent are English-speaking
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDS-UPMINDS-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. | Behavioural | PPW + MINDS-UP |
| Prevention Plus WellnessAlso: PPWPPW 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. | Behavioural | PPW + MINDS-UP, Sport: Prevention Plus Wellness (PPW) |
Primary outcome
Retention
Time frame: Completion of Study (up to 36 months)
Percent of participants who completed all study procedures among those who were randomized
Attendance
Time frame: Completion of Study (up to 36 months)
Percent of scheduled sessions that were completed by the participant.
Teacher Rated Participation
Time frame: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Teacher Rated
Student-Rated Participation
Time frame: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Student Engagement
Homework Completion
Time frame: Completion of Study (up to 36 months)
Percentage of assigned homeworks that were completed by the participant.
Acceptability
Time frame: Completion of Study (up to 36 months)
Acceptability of Intervention Measure
15 secondary outcomes
Total Problems (parent-report)
Time frame: 4-8 weeks, 6 months, and 12 months
ADHD Symptoms
Time frame: 4-6 weeks, 6 months, and 12 months
Suicidal Thoughts/Behaviors
Time frame: 4-6 weeks, 6 months, 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
Cannabis Use
Time frame: 4-6 weeks, 6 months, and 12 months
Total Problems (adolescent report)
Time frame: 4-6 weeks, 6 months, 12 months
Mindfulness
Time frame: 4-6 weeks, 6 months, and 12 months
Anxiety and Depression
Time frame: 4-6 weeks, 6 months, and 12 months
Perceived Tolerance of Use
Time frame: baseline
Perceived Harm of Substance Use
Time frame: baseline
Beliefs About Alcohol Effects
Time frame: baseline
Beliefs About Smoking Effects
Time frame: baseline
Beliefs About Cannabis Effects
Time frame: baseline
Risk and Protective Factors
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MINDS-UP and Prevention Plus Wellness in people with Substance Use, run by New York State Psychiatric Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David C Saunders, MD, PhD (914-409-6807, david.saunders@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Completion of Study (up to 36 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.