Mindfulness-Based Substance Use Prevention (MINDS-UP)

NCT06593470 | Not Yet Recruiting

• 2 other identifiers: #Pro00076319K12DA000357
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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:

• 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

Conditions

Substance Use

Outcome Measures

Primary Outcomes (6)

• 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)

Secondary Outcomes (12)

• MRI retention

  Completion of Study (up to 36 months)

• Future MRI endorsement

  Completion of Study (up to 36 months)

• Anxiety and Depression

  4-6 weeks, 6 months, and 12 months

• Mindfulness

  4-6 weeks, 6 months, and 12 months

• Externalizing Problems (parent-report)

  4-6 weeks, 6 months, and 12 months

Study Arms (3)

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.

Behavioral: Prevention Plus Wellness

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.

Behavioral: MINDS-UP; Behavioral: Prevention Plus Wellness; Diagnostic Test: fMRI

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.

Behavioral: MINDS-UP; Behavioral: Prevention Plus Wellness

Interventions

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.

MINDS-UP with MRI + PPW; MINDS-UP without MRI + PPW

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.

Also known as: PPW

MINDS-UP with MRI + PPW; MINDS-UP without MRI + PPW; Sport: Prevention Plus Wellness (PPW)

fMRI DIAGNOSTIC_TEST

Functional MRI to investigate preliminary neural mechanisms of MINDS-UP

MINDS-UP with MRI + PPW

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Health; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

David C Saunders, MD, PhD

CONTACT

914-409-6807; david.saunders@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Psychiatry

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share