[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":37,"locations":45,"responsibleParty":154,"collaborators":156,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":25,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brief Motivational interviewing-based Alcohol Intervention (BMAI)","ACTIVE_COMPARATOR","Participants randomized to this arm will receive a brief motivational interviewing-based alcohol intervention (BMAI) delivered in person by a pediatric clinician in the pediatric primary care (PPC) office setting.\n\nBMAI is adapted from the Provider Guide: Adolescent SBIRT Using the S2BI-CRAFFT Screening Tool and incorporates motivational interviewing (MI) principles. It includes clinician-delivered feedback, advice, and goal setting to help adolescents recognize links between alcohol\u002Fdrug use and negative health outcomes, and to develop personalized change plans.\n\nBMAI is delivered across one or more visits, with the initial session typically lasting 10-30 minutes and follow-ups lasting 5-15 minutes. Clinicians delivering BMAI include pediatricians, nurses, and social workers who provide primary care to 12-17-year-olds at participating JHMI sites and who have completed SBIRT\u002FBMAI training and monitoring as part of the trial.",[13],"Behavioral: Brief Motivational Interviewing-based Alcohol Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT)","Participants randomized to this arm will receive the BMAI intervention described above plus 8 weeks of adjunctive smartphone-delivered mindfulness training (MT) via the Healthy Minds Program (HMP) app.\n\nThe HMP app offers self-guided, self-paced mindfulness and meditation training, with core modules on Awareness, Insight, Connection, and Purpose. This study focuses on the Awareness and Insight modules, which teach breath and body awareness, noting of emotions, and the application of mindfulness in daily life.\n\nAfter randomization, participants will meet with study staff to download the app, receive instruction, and be asked to use it 5-30 minutes daily, following a pathway of 4 weeks of Awareness content, then 4 weeks of Insight content.\n\nAfter the 8-week MT period, participants will have open access to all HMP modules and be encouraged to explore the remaining content as desired during the follow-up period.",[13,18],"Behavioral: Smartphone App-delivered Mindfulness Training",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Brief Motivational Interviewing-based Alcohol Intervention","Participants in both arms (BMAI and BMAI + MT) will receive a brief motivational interviewing-based alcohol intervention (BMAI) delivered by a pediatric clinician in the primary care setting.\n\nBMAI is adapted from the Provider Guide: Adolescent SBIRT Using the S2BI-CRAFFT Screening Tool, grounded in the stages of change model and motivational interviewing (MI). It consists of one or more brief sessions involving structured feedback, advice, and goal setting to help adolescents recognize links between substance use and health outcomes and develop personalized change plans. The intervention is face-to-face, delivered during routine or follow-up visits, and modeled after the brief negotiated interview. The first session lasts 10-30 minutes and includes six MI-based steps. This is followed by one or more additional brief MI sessions lasting 5-15 minutes where the patient's goals are reviewed, gains or barriers are addressed, and ongoing support is provided.",[15,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Smartphone App-delivered Mindfulness Training","In addition to BMAI, participants in the BMAI + MT arm will receive 8 weeks of smartphone-delivered mindfulness training using the Healthy Minds Program (HMP) app.\n\nThe HMP app provides self-guided, self-paced mindfulness and meditation training designed to improve psychological well-being, reduce stress\u002Fanxiety, and enhance self-regulation. It includes podcast-style teachings and guided meditations. The app features four modules-Awareness, Insight, Connection, and Purpose-based on neuroscience research. Each module offers 27 practices (5-30 minutes each). This study focuses on the Awareness and Insight modules, which teach breath and body awareness and emotion noting to support mindfulness in daily life. Participants will be asked to use the app 5-30 minutes per day, following 4 weeks of Awareness content, then 4 weeks of Insight. After 8 weeks, they will have open access to all modules and be encouraged to explore additional practices as they find helpful during follow-up.",[15],[31,34],{"name":32,"affiliation":5,"role":33},"Christopher J Hammond, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Hoover Adger, MD, MPH, MBA","STUDY_DIRECTOR",[38,42],{"name":32,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","(410) 550-0144","chammo20@jhmi.edu",{"name":43,"role":39,"phone":25,"phoneExt":25,"email":44},"Gabrielle Newton, MPH","gnewton3@jh.edu",[46,60,66,71,78,83,92,101,110,119,128,137,146],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":25},"Johns Hopkins Community Physicians, Remington","NOT_YET_RECRUITING","Baltimore","Maryland","21211","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-76.61219,39.29038,{"lat":58,"lon":57},{"facility":61,"status":48,"city":49,"state":50,"zip":62,"country":52,"countryCode":53,"cosmosGeoPoint":63,"geoPoint":65,"contacts":25},"Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)","21224",{"type":55,"coordinates":64},[57,58],{"lat":58,"lon":57},{"facility":67,"status":48,"city":49,"state":50,"zip":62,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":70,"contacts":25},"Johns Hopkins Community Physicians, Canton Crossing",{"type":55,"coordinates":69},[57,58],{"lat":58,"lon":57},{"facility":72,"status":73,"city":49,"state":50,"zip":74,"country":52,"countryCode":53,"cosmosGeoPoint":75,"geoPoint":77,"contacts":25},"Harriet Lane Clinic","RECRUITING","21287",{"type":55,"coordinates":76},[57,58],{"lat":58,"lon":57},{"facility":79,"status":73,"city":49,"state":50,"zip":74,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":82,"contacts":25},"Johns Hopkins University Center for Adolescent and Young Adult Health",{"type":55,"coordinates":81},[57,58],{"lat":58,"lon":57},{"facility":84,"status":48,"city":85,"state":50,"zip":86,"country":52,"countryCode":53,"cosmosGeoPoint":87,"geoPoint":91,"contacts":25},"Johns Hopkins Community Physicians, Water's Edge","Belcamp","21017",{"type":55,"coordinates":88},[89,90],-76.23329,39.469,{"lat":90,"lon":89},{"facility":93,"status":48,"city":94,"state":50,"zip":95,"country":52,"countryCode":53,"cosmosGeoPoint":96,"geoPoint":100,"contacts":25},"Johns Hopkins Community Physicians, Bowie","Bowie","20715",{"type":55,"coordinates":97},[98,99],-76.73028,38.94278,{"lat":99,"lon":98},{"facility":102,"status":48,"city":103,"state":50,"zip":104,"country":52,"countryCode":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":25},"Johns Hopkins Community Physicians, Howard County Pediatrics","Columbia","21046",{"type":55,"coordinates":106},[107,108],-76.83942,39.24038,{"lat":108,"lon":107},{"facility":111,"status":48,"city":112,"state":50,"zip":113,"country":52,"countryCode":53,"cosmosGeoPoint":114,"geoPoint":118,"contacts":25},"Johns Hopkins Community Physicians, Glen Burnie","Glen Burnie","20161",{"type":55,"coordinates":115},[116,117],-76.62469,39.16261,{"lat":117,"lon":116},{"facility":120,"status":48,"city":121,"state":50,"zip":122,"country":52,"countryCode":53,"cosmosGeoPoint":123,"geoPoint":127,"contacts":25},"Johns Hopkins Community Physicians, Hagerstown","Hagerstown","21742",{"type":55,"coordinates":124},[125,126],-77.71999,39.64176,{"lat":126,"lon":125},{"facility":129,"status":48,"city":130,"state":50,"zip":131,"country":52,"countryCode":53,"cosmosGeoPoint":132,"geoPoint":136,"contacts":25},"Johns Hopkins Community Physicians, White Marsh Pediatrics","Nottingham","21236",{"type":55,"coordinates":133},[134,135],-76.63719,39.19927,{"lat":135,"lon":134},{"facility":138,"status":48,"city":139,"state":50,"zip":140,"country":52,"countryCode":53,"cosmosGeoPoint":141,"geoPoint":145,"contacts":25},"Johns Hopkins Community Physicians, Odenton Medical","Odenton","21113",{"type":55,"coordinates":142},[143,144],-76.70025,39.084,{"lat":144,"lon":143},{"facility":147,"status":48,"city":148,"state":50,"zip":149,"country":52,"countryCode":53,"cosmosGeoPoint":150,"geoPoint":153,"contacts":25},"Johns Hopkins Community Physicians, Rockville Pediatrics","Rockville","20854",{"type":55,"coordinates":151},[152,144],-77.15276,{"lat":144,"lon":152},{"type":155,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[157],{"name":158,"class":6},"Patient-Centered Outcomes Research Institute","100597483","brief-motivational-interviewing---mindfulness-training-for-adolescent-alcohol-use-in-pediatric-primary-care-100597483",false,"NCT07059078","Brief Motivational Interviewing +\u002F- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care","PCORI Comparative Effectiveness Study: Comparative Effectiveness of Brief Motivational Interviewing +\u002F- Adjunctive Smartphone App-delivered Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care Settings","PCORIMINDSET","Inclusion Criteria:\n\n* 12-17 years old\n* Receiving pediatric primary care (PPC) services through the Johns Hopkins Medical Institute healthcare network\n* Screening positive for moderate or high alcohol use risk as indicated by a S2BI score (i.e., showing any monthly alcohol use in the past 12 months)\n* Able to speak, understand, and read in English or Spanish\n* Able to provide assent, and receiving parental consent\u002Fpermission to participate.\n\nExclusion Criteria:\n\n* Severe medical or psychiatric condition (e.g., behavioral dysregulation, psychopathology, or cognitive impairment that in the judgement of study or PPC provider may make participation hazardous \\[e.g., psychosis, homicidality, active suicidality, mania\\])\n* Intellectual Disability (self-, caregiver-, or PPC-reported, or PPC-documented)\n* Current or recent specialty substance use disorder treatment in the past 6 months\n* Demonstrated current physiological alcohol withdrawal requiring urgent inpatient referral in the judgement of study or PPC physician\n* Reported regular opioid, benzodiazepine, or cocaine use (\\> weekly) or history of opioid, benzodiazepine, or cocaine overdose in the past 6 months\n* Previous experience with a mindfulness-based intervention in the past 12 months\n* Current regular meditation practice (\\> 30 min\u002Fday for \\> 5 days avg. over 30 days prior to screening).","ALL","12 Years","17 Years",{"count":171,"type":172},1500,"ESTIMATED","INTERVENTIONAL",[175],"NA","Alcohol use is prevalent in U.S. adolescents and contributes to adverse health outcomes in this population. Care for adolescent alcohol use is lacking in most pediatric primary care settings (PPC). This project is a pragmatic comparative effectiveness and implementation study that employs a superiority, two-arm, randomized, prospective, observer-blinded, controlled trial design to compare the effectiveness of a patient-centered brief motivational interviewing-based alcohol intervention (BMAI) alone to the same BMAI augmented with adjunctive smartphone app-delivered mindfulness training (MT) for alcohol use in adolescents receiving primary care in PPC clinics across a regional health network. Main effectiveness outcomes will be alcohol use and alcohol related problems assessed over a one-year follow-up period. Implementation outcomes and mediators and moderators of intervention response will also be examined as part of the study.",[178],"Adolescent Alcohol Use",[180,181,182,183,184,185,186,187,188,189,190],"Alcohol use","Alcohol-related problems","Drug use","Adolescent","Motivational interviewing","Mindfulness","Mindfulness training","brief alcohol intervention","digital therapeutic intervention","SBIRT","PCORI","2025-09-15",{"date":193,"type":194},"2025-09-16","ACTUAL",{"date":196,"type":194},"2025-09-03",{"date":198,"type":172},"2030-09-30",{"name":5,"class":6},13]