Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2026-03-01
2028-01-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
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.
fMRI
Functional MRI to investigate preliminary neural mechanisms of MINDS-UP
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.
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.
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.
Interventions
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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.
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.
fMRI
Functional MRI to investigate preliminary neural mechanisms of MINDS-UP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Access to a smart phone, tablet, or computer with Wi-Fi
* English-speaking
Exclusion Criteria
* Youth is actively involved in another Boricua Youth Study (BYS)
* Youth's sibling is or has previously been enrolled in MINDS-UP.
10 Years
14 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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David Saunders, MD PhD
Assistant Prof of Psychiatry
Central Contacts
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Other Identifiers
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#Pro00076319
Identifier Type: -
Identifier Source: org_study_id
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