Mindfulness-Based Substance Use Prevention (MINDS-UP)

Sponsor
New York State Psychiatric Institute
Study ID
NCT06593470
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • fMRI — DIAGNOSTIC_TEST
    Functional MRI to investigate preliminary neural mechanisms of MINDS-UP

Study Details

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

Key Dates

First listed
Sep 19, 2024
Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Sport: Prevention Plus Wellness (PPW)
    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.
  • Experimental: MINDS-UP with MRI + PPW
    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.
  • Experimental: MINDS-UP without MRI + PPW
    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.

Primary Outcome Measure

Teacher Rated Participation [ Time Frame: Completion of Study (up to 36 months) ]

Central Contacts

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