NCT06593470

Mindfulness-Based Substance Use Prevention (MINDS-UP)

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

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

Conditions

• Substance Use

Interventions

Type	Name	Description
BEHAVIORAL	MINDS-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.
BEHAVIORAL	Prevention 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_TEST	fMRI	Functional MRI to investigate preliminary neural mechanisms of MINDS-UP

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2024-09-19
• Last updated: 2025-08-19