Substance Use
Conditions
Brief 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. 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
Interventions
BEHAVIORALMINDS-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.
BEHAVIORALPrevention 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.
DIAGNOSTIC_TESTfMRI
Functional MRI to investigate preliminary neural mechanisms of MINDS-UP
Sponsors
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Teacher Rated Participation | Completion of Study (up to 36 months) | Research Assessment Package for Schools - Teacher Rated |
| Acceptability | Completion of Study (up to 36 months) | Acceptability of Intervention Measure |
| Retention | Completion of Study (up to 36 months) | Percent of participants who completed all study procedures among those who were randomized |
| Attendance | Completion of Study (up to 36 months) | Percent of scheduled sessions that were completed by the participant. |
| Homework Completion | Completion of Study (up to 36 months) | Percentage of assigned homeworks that were completed by the participant. |
| Participation (student) | Completion of Study (up to 36 months) | Research Assessment Package for Schools - Student Engagement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI retention | Completion of Study (up to 36 months) | Percentage of participants randomized to receive MRI that complete both MRIs |
| Future MRI endorsement | Completion of Study (up to 36 months) | Percentage of participants who endorse willingness to undergo a future research MRI scan |
| Anxiety and Depression | 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. |
| Mindfulness | 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 |
| Externalizing Problems (parent-report) | 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 |
| Externalizing Problems (self-report) | 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 |
| Total Problems (self-report) | 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 |
| Total Problems (parent-report) | 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 |
| Cannabis Use | 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. |
| Alcohol sipping | 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. |
| Tobacco Use | 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. |
| ADHD Symptoms | 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 |
Contacts
CONTACTDavid C Saunders, MD, PhD
Outcome results
None listed