Mindfulness-Based Substance Use Prevention (MINDS-UP)

New York State Psychiatric Institute

Status

Begins enrollment this month

Conditions

Substance Use

Treatments

Behavioral: Prevention Plus Wellness

Behavioral: MINDS-UP

Diagnostic Test: fMRI

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06593470

#Pro00076319

K12DA000357 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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:

Is MINDS-UP feasible and what is its preliminary efficacy?
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

Enrollment

45 estimated patients

Sex

All

Ages

10 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Sport: Prevention Plus Wellness (PPW)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Prevention Plus Wellness

MINDS-UP with MRI + PPW

Experimental group

Description:

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.

Treatment:

Diagnostic Test: fMRI

Behavioral: MINDS-UP

Behavioral: Prevention Plus Wellness

MINDS-UP without MRI + PPW

Experimental group

Description:

Treatment:

Behavioral: MINDS-UP

Behavioral: Prevention Plus Wellness