Adolescent Alcohol UsePCORIMINDSETNCT07059078
Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
A study testing Brief Motivational Interviewing-based Alcohol Intervention and Smartphone App-delivered Mindfulness Training in people with Adolescent Alcohol Use, run by Johns Hopkins University at 13 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Alcohol Use
- What is being tested?
- Brief Motivational Interviewing-based Alcohol Intervention and Smartphone App-delivered Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 13 sitesUnited States
- Study dates
- 3 Sep 2025to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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/permission to participate.
Who cannot join
- 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/day for > 5 days avg. over 30 days prior to screening).
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gabrielle Newton, MPH contact
13 sites in 1 country
United States13 sites, 13 recruiting
- Not yet recruiting
Johns Hopkins Community Physicians, Remington
Baltimore, Maryland, 21211
- Not yet recruiting
Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)
Baltimore, Maryland, 21224
- Not yet recruiting
Johns Hopkins Community Physicians, Canton Crossing
Baltimore, Maryland, 21224
- Recruiting
Harriet Lane Clinic
Baltimore, Maryland, 21287
- Recruiting
Johns Hopkins University Center for Adolescent and Young Adult Health
Baltimore, Maryland, 21287
- Not yet recruiting
Johns Hopkins Community Physicians, Water's Edge
Belcamp, Maryland, 21017
- Not yet recruiting
Johns Hopkins Community Physicians, Bowie
Bowie, Maryland, 20715
- Not yet recruiting
Johns Hopkins Community Physicians, Howard County Pediatrics
Columbia, Maryland, 21046
- Not yet recruiting
Johns Hopkins Community Physicians, Glen Burnie
Glen Burnie, Maryland, 20161
- Not yet recruiting
Johns Hopkins Community Physicians, Hagerstown
Hagerstown, Maryland, 21742
- Not yet recruiting
Johns Hopkins Community Physicians, White Marsh Pediatrics
Nottingham, Maryland, 21236
- Not yet recruiting
Johns Hopkins Community Physicians, Odenton Medical
Odenton, Maryland, 21113
- Not yet recruiting
Johns Hopkins Community Physicians, Rockville Pediatrics
Rockville, Maryland, 20854
About this study
Official title: PCORI Comparative Effectiveness Study: Comparative Effectiveness of Brief Motivational Interviewing +/- Adjunctive Smartphone App-delivered Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care Settings
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.
Read the detailed description
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).
The 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/mindfulness 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 +/- digital delivery and MI +/- MT will be tested in PPC clinics throughout the Johns Hopkins Medical Institute (JHMI) healthcare network which primarily serves racially/ethnically diverse population of urban and suburban youth in the greater Baltimore/Washington region that has a high proportion of minoritized youth.
The project seeks to answer the following three research questions:
Comparative 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?
Implementation 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?
Heterogeneity 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/reduce 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?
- Conditions
- Adolescent Alcohol Use
- Being tested
- Brief Motivational Interviewing-based Alcohol Intervention, Smartphone App-delivered Mindfulness Training
- Keywords
- Alcohol use, Alcohol-related problems, Drug use, Adolescent, Motivational interviewing, Mindfulness, Mindfulness training, brief alcohol intervention, digital therapeutic intervention, SBIRT, PCORI
- Medical subject headings
- Underage Drinking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Interviewing-based Alcohol InterventionBehavioural
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.
BMAI 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.
Smartphone App-delivered Mindfulness TrainingBehavioural
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.
The HMP app provides self-guided, self-paced mindfulness and meditation training designed to improve psychological well-being, reduce stress/anxiety, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
BMAI 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/drug use and negative health outcomes, and to develop personalized change plans.
BMAI 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/BMAI training and monitoring as part of the trial. Receives: Behavioral: Brief Motivational Interviewing-based Alcohol Intervention |
| BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT) | Active comparator | 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.
The 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.
After 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.
After 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. Receives: Behavioral: Brief Motivational Interviewing-based Alcohol Intervention; Behavioral: Smartphone App-delivered Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Month 2
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.
Measured: Month 2
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.
Measured: month 3, and month 12
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.
Measured: Month 2
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.
Measured: Month 2
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.
Measured: month 3, and month 12
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.
Measured: Baseline, month 3, and month 12
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.
Measured: Baseline, month 3, and month 12
Secondary outcomes (9)
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.
Measured: Baseline, 1, 3, 6, and 12 months
Cannabis use days in the past 30 days
Cannabis/ 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.
Measured: Baseline, 1, 3, 6, and 12 months
Tobacco/nicotine use days in the past 30 days
Tobacco/nicotine 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.
Measured: Baseline, 1, 3, 6, and 12 months
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/nicotine 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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start3 Sep 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Alcohol UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Christopher J Hammond, MD, PhD, Principal investigator, Johns Hopkins UniversityHoover Adger, MD, MPH, MBA, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059078
- Sponsor's protocol ID
- IRB00452272
- Acronym
- PCORIMINDSET
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCORI Comparative Effectiveness Study: Comparative Effectiveness of Brief Motivational Interviewing +/- Adjunctive Smartphone App-delivered Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care Settings
- ClinicalTrials.gov ID
- NCT07059078
- Acronym / sponsor ID
- PCORIMINDSET / IRB00452272
- Conditions
- Adolescent Alcohol Use
- Keywords
- Alcohol use, Alcohol-related problems, Drug use, Adolescent, Motivational interviewing, Mindfulness, Mindfulness training, brief alcohol intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
The 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/mindfulness 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 +/- digital delivery and MI +/- MT will be tested in PPC clinics throughout the Johns Hopkins Medical Institute (JHMI) healthcare network which primarily serves racially/ethnically diverse population of urban and suburban youth in the greater Baltimore/Washington region that has a high proportion of minoritized youth.
The project seeks to answer the following three research questions:
Comparative 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?
Implementation 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?
Heterogeneity 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/reduce 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational interviewing-based Alcohol Intervention (BMAI) | Active comparator | Behavioral: Brief Motivational Interviewing-based Alcohol InterventionParticipants 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. BMAI 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/drug use and negative health outcomes, and to develop personalized change plans. BMAI 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/BMAI training and monitoring as part of the trial. |
| BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT) | Active comparator | Behavioral: Brief Motivational Interviewing-based Alcohol Intervention, Behavioral: Smartphone App-delivered Mindfulness TrainingParticipants 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. The 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. After 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. After 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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/permission to participate.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational Interviewing-based Alcohol InterventionParticipants 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. BMAI 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. | Behavioural | BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT), Brief Motivational interviewing-based Alcohol Intervention (BMAI) |
| Smartphone App-delivered Mindfulness TrainingIn 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. The HMP app provides self-guided, self-paced mindfulness and meditation training designed to improve psychological well-being, reduce stress/anxiety, 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. | Behavioural | BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT) |
Primary outcome
Alcohol Use (total standard drinks) in the past 30 days
Time frame: Baseline, 1, 3, 6, and 12 months
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.
Acceptability of intervention (adolescent report) assessed by the Client Satisfaction Questionnaire-Patient Report
Time frame: Month 2
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.
Acceptability of intervention (caregiver report) assessed by the Client Satisfaction Questionnaire-Caregiver Report
Time frame: Month 2
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.
Acceptability of intervention (provider report) assessed by the Provider Satisfaction Questionnaire
Time frame: month 3, and month 12
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.
Intervention experiences, perspectives, and preferences (adolescent report) assessed by qualitative interview
Time frame: Month 2
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.
Intervention experiences, perspectives, and preferences (caregiver report) assessed by qualitative interview
Time frame: Month 2
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.
Intervention experiences, perspectives, and preferences (provider report) assessed by qualitative interview
Time frame: month 3, and month 12
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.
Implementation barriers and facilitators for SBIRT and BMAI (provider report)
Time frame: Baseline, month 3, and month 12
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.
Percentage of providers reporting barriers and facilitators (provider report)
Time frame: Baseline, month 3, and month 12
Percentage of providers reporting specific types of barriers and facilitators will serve as the implementation outcome.
9 secondary outcomes
Heavy episodic drinking (HED) days in the past 30 days
Time frame: Baseline, 1, 3, 6, and 12 months
Cannabis use days in the past 30 days
Time frame: Baseline, 1, 3, 6, and 12 months
Tobacco/nicotine use days in the past 30 days
Time frame: Baseline, 1, 3, 6, and 12 months
Other drug use days in the past 30 days
Time frame: Baseline, 1, 3, 6, and 12 months
Alcohol-related problem severity assessed by the Alcohol Use Disorders Identification Test
Time frame: Baseline, 1, 3, 6, and 12 months
Recent Alcohol Consumption (past 7 days)
Time frame: Baseline, 1, 3, 6, and 12 months
Alcohol-related consequences assessed by the Short Index of Problems
Time frame: Baseline, 1, 3, 6, and 12 months
Emergency health service utilization
Time frame: Baseline, 1, 3, 6, and 12 months
Quality of Life (QOL) as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline, 1, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Adolescent Alcohol Use
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Not yet recruiting
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
Adolescent Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabrielle Newton, MPH contact
Christopher J Hammond, MD, PhD principal investigator
Johns Hopkins University
Hoover Adger, MD, MPH, MBA study director
Johns Hopkins University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Interviewing-based Alcohol Intervention and Smartphone App-delivered Mindfulness Training in people with Adolescent Alcohol Use, run by Johns Hopkins University at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher J Hammond, MD, PhD ((410) 550-0144, chammo20@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (total standard drinks) in the past 30 days (time frame: Baseline, 1, 3, 6, and 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.