[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07059078":3,"trial-entities:NCT07059078":230,"trial-summary:NCT07059078":234},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":51,"secondary_outcomes":83,"sex":111,"minimum_age":112,"maximum_age":113,"healthy_volunteers":114,"eligibility_criteria":115,"std_ages":131,"locations":133,"central_contacts":213,"overall_officials":222,"references":228,"see_also_links":229},"NCT07059078","IRB00452272","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","RECRUITING","2030-09-30","2025-09","2025-09-16","2025-09-03","Johns Hopkins University","OTHER",true,"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.","Alcohol use is prevalent in U.S. adolescents and contributes to adverse health outcomes in this population. Over the past decade, screening, brief intervention, and referral to treatment (SBIRT) has become the primary model for addressing alcohol problems in US adolescents in pediatric healthcare settings. However, uptake and fidelity of SBIRT vary widely in real world settings and barriers to implementing effective brief interventions are common. Standard brief alcohol interventions (BAIs) have predominantly applied motivational interviewing (MI) and feedback techniques to target alcohol and other drug use in adolescents. There is a need to expand BAI options for youth who do not respond to these standard approaches. One intervention approach with growing societal interest and emerging evidence for efficacy in adolescent alcohol and other drug use is mindfulness training (MT). This project will compare two types of evidenced-based care for alcohol use in adolescents recruited from 13 pediatric primary care clinics in a regional health system. The interventions will be a patient-centered brief motivational interviewing-based alcohol intervention (BMAI) delivered by PPC clinicians as part of routine care, and BMAI in combination with smartphone app-delivered mindfulness training (BMAI+ MT).\n\nThe project is a pragmatic effectiveness and implementation study that employs a superiority, two-arm, randomized, prospective, observer-blinded, controlled trial design to compare the effectiveness of BMAI alone vs. BMAI augmented with adjunctive smartphone app-delivered MT on alcohol outcomes over a one-year follow-up period. The investigators will use the well-established standard BMAI adapted from the Provider Guide: Adolescent SBIRT Using the Screening to Brief Intervention Car, Relax, Alone, Forget, Friends, Trouble (S2BI-CRAFFT) Screening Tool, an evidence-based brief intervention for alcohol use in youth, and the widely disseminated Healthy Minds Program (HMP) smartphone meditation\u002Fmindfulness app which is freely available, science-based, and has shown feasibility and efficacy for reducing stress in youth populations. These interventions which combine elements of face-to-face +\u002F- digital delivery and MI +\u002F- MT will be tested in PPC clinics throughout the Johns Hopkins Medical Institute (JHMI) healthcare network which primarily serves racially\u002Fethnically diverse population of urban and suburban youth in the greater Baltimore\u002FWashington region that has a high proportion of minoritized youth.\n\nThe project seeks to answer the following three research questions:\n\nComparative effectiveness outcomes: What is the relative effectiveness of face-to-face clinician-administered BMAI with vs. without adjunctive app-delivered MT with the HMP app for alcohol using youth in PPC settings? Does supplementing clinician-administered BMAI with app-delivered MT result in superior outcomes in the form of reduced alcohol use and problems for this population or subgroups of the population?\n\nImplementation outcomes: What are the patient and stakeholder perspectives, experiences, and preferences related to delivering BAI with these different components? What are the barriers and facilitators to delivering these BAI in PPC settings and for the diverse patient population served?\n\nHeterogeneity of treatment effect (HTE) outcomes: How do baseline factors such as clinical severity, comorbid psychiatric symptoms and conditions, Socio-economic status (SES), sex, race, ethnicity, caregiver involvement, treatment preference, organization and clinical site readiness, and level of SBIRT integration at PPC clinic sites moderate outcomes across comparator interventions? How do changes in factors that may be mechanism of behavioral change (MOBC) for the different interventions (e.g. 'intrinsic' motivation to quit\u002Freduce drinking, self-efficacy, and goal commitment for MI and mindfulness, anxiety, depression, impulsivity, and self-regulation for MT) and degree of engagement with intervention components (e.g., no. of sessions attended, time spent and no. of MT exercises completed, application of mindfulness in real-life settings) mediate outcomes across comparator interventions? Which patient subgroups benefit the most from which specific mindfulness and motivational BAI components?",[19],"Adolescent Alcohol Use",[21,22,23,24,25,26,27,28,29,30,31],"Alcohol use","Alcohol-related problems","Drug use","Adolescent","Motivational interviewing","Mindfulness","Mindfulness training","brief alcohol intervention","digital therapeutic intervention","SBIRT","PCORI","INTERVENTIONAL","TREATMENT",[35],"NA",{"count":37,"type":38},1500,"ESTIMATED",[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44},"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.",[45,46],"BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT)","Brief Motivational interviewing-based Alcohol Intervention (BMAI)",{"type":41,"name":48,"description":49,"armGroupLabels":50},"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.",[45],[52,56,60,63,67,70,73,76,80],{"measure":53,"description":54,"timeFrame":55},"Alcohol Use (total standard drinks) in the past 30 days","Alcohol use (total standard drinks) in the past 30 days, measured via Timeline Follow Back (TLFB) calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.","Baseline, 1, 3, 6, and 12 months",{"measure":57,"description":58,"timeFrame":59},"Acceptability of intervention (adolescent report) assessed by the Client Satisfaction Questionnaire-Patient Report","Adolescent reported acceptability of BMAI and MT intervention components will be assessed via the Client Satisfaction Questionnaire-Patient Report (CSQ-Patient Report) collected at month 2. CSQ Patient Report scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.","Month 2",{"measure":61,"description":62,"timeFrame":59},"Acceptability of intervention (caregiver report) assessed by the Client Satisfaction Questionnaire-Caregiver Report","Caregiver reported acceptability of BMAI and MT components will be assessed via the Client Satisfaction Questionnaire-Caregiver Report (CSQ-Caregiver Report) at month 2. CSQ Caregiver Report scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.",{"measure":64,"description":65,"timeFrame":66},"Acceptability of intervention (provider report) assessed by the Provider Satisfaction Questionnaire","Provider reported acceptability of BMAI and MT components will be assessed via the Provider Satisfaction Questionnaire (PSQ), an adapted form of the Client Satisfaction Questionnaire at month 3 and month 12. PSQ scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.","month 3, and month 12",{"measure":68,"description":69,"timeFrame":59},"Intervention experiences, perspectives, and preferences (adolescent report) assessed by qualitative interview","Adolescent reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from adolescent participants at 2 months. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.",{"measure":71,"description":72,"timeFrame":59},"Intervention experiences, perspectives, and preferences (caregiver report) assessed by qualitative interview","Caregiver reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from caregiver's of adolescent participants at 2 months. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.",{"measure":74,"description":75,"timeFrame":66},"Intervention experiences, perspectives, and preferences (provider report) assessed by qualitative interview","Provider reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from pediatric primary care (PPC) providers obtained at months 3 and 12. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.",{"measure":77,"description":78,"timeFrame":79},"Implementation barriers and facilitators for SBIRT and BMAI (provider report)","Provider reported barriers and facilitators related to implementation of BMAI intervention and screening brief intervention and referral to treatment (SBIRT) framework, assessed using items about perceived barriers and facilitators from the SBIRT provider questionnaire obtained from PPC clinicians at baseline, month 3, and month 12. The SBIRT provider questionnaire includes questions on substance use screening, brief intervention, and SBIRT practices and perceived barriers and facilitators to screening, providing brief interventions, and implementing SBIRT in their PPC office setting. Number of barriers, number of facilitators, and percentage of providers reporting specific types of barriers and facilitators will be serve as the implementation outcome.","Baseline, month 3, and month 12",{"measure":81,"description":82,"timeFrame":79},"Percentage of providers reporting barriers and facilitators (provider report)","Percentage of providers reporting specific types of barriers and facilitators will serve as the implementation outcome.",[84,87,90,93,96,99,102,105,108],{"measure":85,"description":86,"timeFrame":55},"Heavy episodic drinking (HED) days in the past 30 days","Heavy episodic drinking days in the past 30 days (defined as number of days in the past 30 days where participant consumed \\> 5 drinks for male and \\> 4 drinks for female participants in single session), measured via TLFB calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":88,"description":89,"timeFrame":55},"Cannabis use days in the past 30 days","Cannabis\u002F tetrahydrocannabinol (THC) product use days in the past 30 days, measured via TLFB calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":91,"description":92,"timeFrame":55},"Tobacco\u002Fnicotine use days in the past 30 days","Tobacco\u002Fnicotine product use days in the past 30 days, measured via TLFB calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":94,"description":95,"timeFrame":55},"Other drug use days in the past 30 days","Other drug use days in the past 30 days (defined as number of days in the past 30 days where drugs other than alcohol, cannabis, tobacco\u002Fnicotine were used), measured via TLFB calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":97,"description":98,"timeFrame":55},"Alcohol-related problem severity assessed by the Alcohol Use Disorders Identification Test","Alcohol-related problem severity measured via the Alcohol Use Disorders Identification Test consumption questions (AUDIT-C) at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups. The AUDIT-C consists of 3 items assessing typical drinking frequency, typical drinking quantity, and frequency of heavy episodic drinking, each scored from 0 to 4. The AUDIT-C composite score has a scale that ranges from 0 to 12 with higher scores indicating greater alcohol problem severity. A total AUDIT-C score \\> or equal to 3 has a good sensitivity and specificity for detecting alcohol use problems in adolescents.",{"measure":100,"description":101,"timeFrame":55},"Recent Alcohol Consumption (past 7 days)","Recent alcohol consumption (defined as total number of standard drinks in the past 7 days), measured via TLFB calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":103,"description":104,"timeFrame":55},"Alcohol-related consequences assessed by the Short Index of Problems","Alcohol-related consequences assessed with the Short Index of Problems (SIP) related to alcohol consumption at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups. The SIP consists of 17 questions each scored from 0 to 3. The scale ranges from 0 to 51 with higher scores indicating greater occurrence of alcohol related negative consequences.",{"measure":106,"description":107,"timeFrame":55},"Emergency health service utilization","Emergency health service utilization (defined as the number of visits to the emergency room for health treatment), measured via 1-item on emergency department visits from The Economic Form-90 at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.",{"measure":109,"description":110,"timeFrame":55},"Quality of Life (QOL) as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)","Quality of Life (QOL) assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric global health (PGH-7) index at five time points (baseline and 1, 2, 3, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.The PROMIS PGH-7 index consists of 7 questions each scored from 1 to 5. The scale ranges from 7 to 35 with higher scores indicating greater QOL and general health.","ALL","12 Years","17 Years",false,{"inclusion":116,"exclusion":122,"raw_text":130},[117,118,119,120,121],"12-17 years old","Receiving pediatric primary care (PPC) services through the Johns Hopkins Medical Institute healthcare network","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)","Able to speak, understand, and read in English or Spanish","Able to provide assent, and receiving parental consent\u002Fpermission to participate.",[123,124,125,126,127,128,129],"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\\])","Intellectual Disability (self-, caregiver-, or PPC-reported, or PPC-documented)","Current or recent specialty substance use disorder treatment in the past 6 months","Demonstrated current physiological alcohol withdrawal requiring urgent inpatient referral in the judgement of study or PPC physician","Reported regular opioid, benzodiazepine, or cocaine use (\\> weekly) or history of opioid, benzodiazepine, or cocaine overdose in the past 6 months","Previous experience with a mindfulness-based intervention in the past 12 months","Current regular meditation practice (\\> 30 min\u002Fday for \\> 5 days avg. over 30 days prior to screening).","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).",[132],"CHILD",[134,144,148,151,155,158,165,172,179,186,193,200,207],{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"Johns Hopkins Community Physicians, Remington","NOT_YET_RECRUITING","Baltimore","Maryland","21211","United States",{"lat":142,"lon":143},39.29038,-76.61219,{"facility":145,"status":136,"city":137,"state":138,"zip":146,"country":140,"geoPoint":147},"Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)","21224",{"lat":142,"lon":143},{"facility":149,"status":136,"city":137,"state":138,"zip":146,"country":140,"geoPoint":150},"Johns Hopkins Community Physicians, Canton Crossing",{"lat":142,"lon":143},{"facility":152,"status":8,"city":137,"state":138,"zip":153,"country":140,"geoPoint":154},"Harriet Lane Clinic","21287",{"lat":142,"lon":143},{"facility":156,"status":8,"city":137,"state":138,"zip":153,"country":140,"geoPoint":157},"Johns Hopkins University Center for Adolescent and Young Adult Health",{"lat":142,"lon":143},{"facility":159,"status":136,"city":160,"state":138,"zip":161,"country":140,"geoPoint":162},"Johns Hopkins Community Physicians, Water's Edge","Belcamp","21017",{"lat":163,"lon":164},39.469,-76.23329,{"facility":166,"status":136,"city":167,"state":138,"zip":168,"country":140,"geoPoint":169},"Johns Hopkins Community Physicians, Bowie","Bowie","20715",{"lat":170,"lon":171},38.94278,-76.73028,{"facility":173,"status":136,"city":174,"state":138,"zip":175,"country":140,"geoPoint":176},"Johns Hopkins Community Physicians, Howard County Pediatrics","Columbia","21046",{"lat":177,"lon":178},39.24038,-76.83942,{"facility":180,"status":136,"city":181,"state":138,"zip":182,"country":140,"geoPoint":183},"Johns Hopkins Community Physicians, Glen Burnie","Glen Burnie","20161",{"lat":184,"lon":185},39.16261,-76.62469,{"facility":187,"status":136,"city":188,"state":138,"zip":189,"country":140,"geoPoint":190},"Johns Hopkins Community Physicians, Hagerstown","Hagerstown","21742",{"lat":191,"lon":192},39.64176,-77.71999,{"facility":194,"status":136,"city":195,"state":138,"zip":196,"country":140,"geoPoint":197},"Johns Hopkins Community Physicians, White Marsh Pediatrics","Nottingham","21236",{"lat":198,"lon":199},39.19927,-76.63719,{"facility":201,"status":136,"city":202,"state":138,"zip":203,"country":140,"geoPoint":204},"Johns Hopkins Community Physicians, Odenton Medical","Odenton","21113",{"lat":205,"lon":206},39.084,-76.70025,{"facility":208,"status":136,"city":209,"state":138,"zip":210,"country":140,"geoPoint":211},"Johns Hopkins Community Physicians, Rockville Pediatrics","Rockville","20854",{"lat":205,"lon":212},-77.15276,[214,219],{"name":215,"role":216,"phone":217,"email":218},"Christopher J Hammond, MD, PhD","CONTACT","(410) 550-0144","chammo20@jhmi.edu",{"name":220,"role":216,"email":221},"Gabrielle Newton, MPH","gnewton3@jh.edu",[223,225],{"name":215,"affiliation":13,"role":224},"PRINCIPAL_INVESTIGATOR",{"name":226,"affiliation":13,"role":227},"Hoover Adger, MD, MPH, MBA","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":231,"biomarkers":233},[232],"Underage Drinking",[],{"nct_id":4,"found":15,"summary":235,"prompt_version":243},{"design":236,"status":237,"heading":6,"summary":238,"follow_up":236,"word_count":239,"commitments":240,"compensation":241,"drugs_mentioned":242},"Not specified.","completed","{\n   \"Brief Motivational Interviewing and Mindfulness for Adolescent Alcohol Use\",\n   \"This study is looking at ways to help adolescents (teenagers) who use alcohol. It compares two approaches: a brief motivational interviewing-based alcohol intervention (BMAI) delivered by a doctor or nurse, and BMAI combined with smartphone-delivered mindfulness training. The goal is to see which approach is more effective at reducing alcohol use. You might be able to join if you are 12-17 years old, receive care at Johns Hopkins Medical Institute, and have screened positive for moderate or high alcohol use risk. Researchers will measure how much alcohol is used over 12 months and how acceptable the interventions are to both adolescents and their caregivers.\",\n  \"design\": \"This is a randomized study comparing two interventions in 1500 participants. It is observer-blinded, meaning some people involved in the study won't know which treatment you receive.\",\n  \"commitments\": \"You would receive an intervention from a pediatric clinician, and potentially use a smartphone app for 8 weeks. Your alcohol use will be measured at the start, and then at 1, 3, 6, and 12 months.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 12 months after starting the intervention to track alcohol use.\",\n}",203,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]