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| ID | Type | Description | Link |
|---|---|---|---|
| K12DA000357 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 remote-delivered 45-minute session by a research assistant (RA) trained in PPW 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. |
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| MINDS-UP with MRI + PPW | 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. Half of those randomized to receive MINDS-UP + PPW (n=10) will receive functional and structural MRI before and after MINDS-UP to evaluate feasibility and acceptability of our MRI procedures and study design. Participants randomized to MINDS-UP with MRI arm will also complete PPW. |
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| MINDS-UP without MRI + PPW | 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 without MRI arm will also complete PPW. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Teacher Rated Participation | Research Assessment Package for Schools - Teacher Rated | Completion of Study (up to 36 months) |
| Acceptability | Acceptability of Intervention Measure | Completion of Study (up to 36 months) |
| Retention | Percent of participants who completed all study procedures among those who were randomized | Completion of Study (up to 36 months) |
| Attendance | Percent of scheduled sessions that were completed by the participant. | Completion of Study (up to 36 months) |
| Homework Completion | Percentage of assigned homeworks that were completed by the participant. | Completion of Study (up to 36 months) |
| Participation (student) | Research Assessment Package for Schools - Student Engagement | Completion of Study (up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| MRI retention | Percentage of participants randomized to receive MRI that complete both MRIs | Completion of Study (up to 36 months) |
| Future MRI endorsement | Percentage of participants who endorse willingness to undergo a future research MRI scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David C Saunders, MD, PhD | Contact | 914-409-6807 | david.saunders@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006262 | Health |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Prevention Plus Wellness | Behavioral | PPW is a standardized, empirically-based intervention for substance use prevention in adolescents ages 10-14. It consists of 1 45-60 minute session between an adolescent and a trained PPW teacher. |
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| fMRI | Diagnostic Test | Functional MRI to investigate preliminary neural mechanisms of MINDS-UP |
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| Completion of Study (up to 36 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. | 4-6 weeks, 6 months, and 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 | 4-6 weeks, 6 months, and 12 months |
| Externalizing Problems (parent-report) | 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 | 4-6 weeks, 6 months, and 12 months |
| Externalizing Problems (self-report) | 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 | 4-6 weeks, 6 months, and 12 months |
| Total Problems (self-report) | 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 | 4-6 weeks, 6 months, and 12 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 | 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. | 4-6 weeks, 6 months, and 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. | 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. | 4-6 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 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 | 4-6 weeks, 6 months, and 12 months |
| D003933 | Diagnosis |