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NCT Number: NCT06593470

Mindfulness-Based Substance Use Prevention (MINDS-UP)

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).

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Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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]
  • Youth has access to a smartphone, tablet, or computer with Wi-Fi
  • Youth and parent are English-speaking

Exclusion criteria

  • 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.

Treatment and study plan

MINDS-UP

Behavioral

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 Wellness

Behavioral

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.

Other names: PPW

Primary outcomes

  1. Retention

    Time frame: Completion of Study (up to 36 months)

    Percent of participants who completed all study procedures among those who were randomized

  2. Attendance

    Time frame: Completion of Study (up to 36 months)

    Percent of scheduled sessions that were completed by the participant.

  3. Teacher Rated Participation

    Time frame: Completion of Study (up to 36 months)

    Research Assessment Package for Schools - Teacher Rated

  4. Student-Rated Participation

    Time frame: Completion of Study (up to 36 months)

    Research Assessment Package for Schools - Student Engagement

  5. Homework Completion

    Time frame: Completion of Study (up to 36 months)

    Percentage of assigned homeworks that were completed by the participant.

  6. Acceptability

    Time frame: Completion of Study (up to 36 months)

    Acceptability of Intervention Measure

Secondary outcomes

  1. Total Problems (parent-report)

    Time frame: 4-8 weeks, 6 months, and 12 months

    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

  2. ADHD Symptoms

    Time frame: 4-6 weeks, 6 months, and 12 months

    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).

  3. Suicidal Thoughts/Behaviors

    Time frame: 4-6 weeks, 6 months, 12 months

    The C-SSRS is a gold-standard assessment tool for suicide risk. This tool will be administered at every visit.

  4. Alcohol sipping

    Time frame: 4-6 weeks, 6 months, and 12 months

    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.

  5. Tobacco Use

    Time frame: 4-6 weeks, 6 months, and 12 months

    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.

  6. Cannabis Use

    Time frame: 4-6 weeks, 6 months, and 12 months

    Cannabis use as measured by the Marijuana Low-Level Use Measure, a short tool that measures early/first use of cannabis.

  7. Total Problems (adolescent report)

    Time frame: 4-6 weeks, 6 months, 12 months

    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.

  8. Mindfulness

    Time frame: 4-6 weeks, 6 months, and 12 months

    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

  9. Anxiety and Depression

    Time frame: 4-6 weeks, 6 months, and 12 months

    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.

  10. Perceived Tolerance of Use

    Time frame: baseline

    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.

  11. Perceived Harm of Substance Use

    Time frame: baseline

    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.

  12. Beliefs About Alcohol Effects

    Time frame: baseline

    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.

  13. Beliefs About Smoking Effects

    Time frame: baseline

    The Adolescent Smoking Consequences Questionnaire (ASCQ) is a 30-item self-report instrument used to assess outcome expectancies of cigarette smoking among adolescents.

  14. Beliefs About Cannabis Effects

    Time frame: baseline

    Brief -Marijuana Effect Expectancies Questionnaire (MEEQ-B) is a 6-item self-report assessment of an adolescent's expected effect of marijuana.

  15. Risk and Protective Factors

    Time frame: Baseline

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: MINDS-UP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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