NCT Number: NCT06593470
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
Trial opening soon.
Get Notified10 year–14 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 45-60 minute session between an adolescent and a trained PPW teacher.
Other names: PPW
Functional MRI to investigate preliminary neural mechanisms of MINDS-UP
Time frame: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Teacher Rated
Time frame: Completion of Study (up to 36 months)
Acceptability of Intervention Measure
Time frame: Completion of Study (up to 36 months)
Percent of participants who completed all study procedures among those who were randomized
Time frame: Completion of Study (up to 36 months)
Percent of scheduled sessions that were completed by the participant.
Time frame: Completion of Study (up to 36 months)
Percentage of assigned homeworks that were completed by the participant.
Time frame: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Student Engagement
Time frame: Completion of Study (up to 36 months)
Percentage of participants randomized to receive MRI that complete both MRIs
Time frame: Completion of Study (up to 36 months)
Percentage of participants who endorse willingness to undergo a future research MRI scan
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.
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
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 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
Time frame: 4-6 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 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
Time frame: 4-6 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 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
Time frame: 4-6 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
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.
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.
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.
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 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
Contact information is provided by the study sponsor or research team.
New York State Psychiatric Institute
Other
Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial
Acronym: MINDS-UP
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