[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561692":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":43,"locations":31,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":28,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":31,"overallStatus":77,"whyStopped":31,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":31},{"fullName":5,"class":6},"New York State Psychiatric Institute","OTHER",[8,14,21],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Prevention Plus Wellness",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19,13,20],"Behavioral: MINDS-UP","Diagnostic Test: fMRI",{"label":22,"type":16,"description":23,"interventionNames":24},"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.",[19,13],[26,32,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","MINDS-UP","MINDS-UP is a substance use prevention program for children\u002Fadolescents.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\u002FCommunity; Kindness, Compassion, Joy and Equanimity, respectively.",[15,22],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"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.",[15,22,9],[37],"PPW",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":31},"DIAGNOSTIC_TEST","fMRI","Functional MRI to investigate preliminary neural mechanisms of MINDS-UP",[15],[44],{"name":45,"role":46,"phone":47,"phoneExt":31,"email":48},"David C Saunders, MD, PhD","CONTACT","914-409-6807","david.saunders@nyspi.columbia.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","David Saunders, MD PhD","Assistant Prof of Psychiatry",[54],{"name":55,"class":56},"National Institute on Drug Abuse (NIDA)","NIH","100561692","mindfulness-based-substance-use-prevention-minds-up-100561692",false,"NCT06593470","Mindfulness-Based Substance Use Prevention (MINDS-UP)","Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial","Inclusion Criteria:\n\n* Youth is ages 10-14 years on the day of screening \\[i.e., does not turn 15 before or on the day of screening\\]\n* Access to a smart phone, tablet, or computer with Wi-Fi\n* English-speaking\n\nExclusion Criteria:\n\n* 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.\n* Youth is actively involved in another Boricua Youth Study (BYS)\n* Youth's sibling is or has previously been enrolled in MINDS-UP.",true,"ALL","10 Years","14 Years",{"count":69,"type":70},45,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to test the feasibility, behavioral\u002Fneural 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:\n\n1. Is MINDS-UP feasible and what is its preliminary efficacy?\n2. Are MRI protocol and procedures feasible?\n\nAn additional exploratory question is:\n\nAre there neural and psychopathological mechanisms through which MINDS-UP might work?\n\nResearchers 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.\n\nParticipants will\n\n* take assessment #1\n* have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start\n* take assessment #2\n* take PPW, a single remote and research assistant-delivered 45-minute session\n* take assessment #3\n* take assessment #4",[76],"Substance Use","NOT_YET_RECRUITING","2026-04-21",{"date":80,"type":81},"2026-04-24","ACTUAL",{"date":83,"type":70},"2026-10-01",{"date":85,"type":70},"2028-01-01",{"name":5,"class":6}]