Motivational Interviewing + Mindfulness for Adolescent Alcohol Use

(PCORIMINDSET Trial)

Recruiting at 12 trial locations

Overseen By Gabrielle Newton, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Opioids, Benzodiazepines, Cocaine

Disqualifiers: Severe psychiatric condition, Intellectual disability, Recent substance treatment, Alcohol withdrawal, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to assist adolescents at risk of alcohol-related problems. It compares two approaches: brief motivational interviewing, a counseling technique that encourages positive change, and the addition of mindfulness training through a smartphone app. The goal is to determine which method more effectively reduces alcohol use and related issues. Adolescents aged 12-17 who regularly visit a pediatrician and have shown signs of alcohol use in the past year may be suitable for this study. As an unphased study, this trial provides a unique opportunity for participants to contribute to innovative research that could lead to more effective interventions for alcohol-related issues in adolescents.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on alcohol use and mindfulness training.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments in this study are safe. Studies indicate that the Brief Motivational Interviewing-based Alcohol Intervention (BMAI) is well-received by young adults. Participants reported drinking less alcohol and experiencing fewer alcohol-related issues without significant negative effects.

Regarding the smartphone app-delivered Mindfulness Training (MT), research suggests it is also safe and helpful. Studies have found that mindfulness apps like the Healthy Minds Program can reduce symptoms of depression and anxiety, which often link to alcohol use. Users did not report serious side effects, making it a safe choice for many.

Overall, previous studies have shown that both the BMAI and the mindfulness app are well-received, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for adolescent alcohol use because they combine motivational interviewing with innovative techniques. The Brief Motivational Interviewing-based Alcohol Intervention (BMAI) stands out by using direct clinician feedback and personalized goal setting, delivered in pediatric primary care settings, to help teens recognize the impact of alcohol use. The addition of smartphone-delivered mindfulness training (MT) via the Healthy Minds Program app further distinguishes this approach by integrating self-guided mindfulness and meditation practices. This dual approach not only addresses the behavioral aspects of alcohol use but also leverages technology to enhance self-awareness and emotional regulation, offering a comprehensive and engaging strategy for teens.

What evidence suggests that this trial's treatments could be effective for adolescent alcohol use?

Research has shown that brief motivational interviewing (BMAI), which participants in this trial may receive, can help young people reduce drinking and alcohol-related problems. One study found that these short conversations significantly decreased drinking and alcohol issues among teenagers. Additionally, smartphone apps that teach mindfulness, like the one used in this trial, have helped with substance use treatment by increasing users' awareness of their thoughts and feelings. This trial will test the combination of BMAI with mindfulness training to determine if it might be an even more effective method for helping teens reduce alcohol use. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher J Hammond, MD, PhD

Principal Investigator

Johns Hopkins University

Hoover Adger, MD, MPH, MBA

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adolescents who use alcohol and are receiving care in pediatric primary care settings. Participants should be willing to engage with a smartphone app if assigned to that group. Specific inclusion or exclusion criteria aren't provided, but typically these would relate to age, health status, and willingness to follow the study procedures.

Inclusion Criteria

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 provide assent, and receiving parental consent/permission to participate.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief motivational interviewing-based alcohol intervention (BMAI) with or without adjunctive smartphone app-delivered mindfulness training (MT) over an 8-week period.

8 weeks

1-2 visits (in-person) for BMAI, daily app usage for MT

Follow-up

Participants are monitored for alcohol use and related outcomes over a one-year period.

12 months

5 visits (in-person or virtual) at baseline, 1, 3, 6, and 12 months

Open-label extension (optional)

Participants may continue to use the mindfulness app and receive support as needed.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Brief Motivational Interviewing-based Alcohol Intervention
• Smartphone App-delivered Mindfulness Training

Trial Overview The study is testing two approaches: one where teens talk with someone trained in motivational interviewing about their drinking (BMAI), and another where they get the same talks plus mindfulness training through an app (BMAI+MT). They'll track which method helps reduce alcohol use better over a year.

How Is the Trial Designed?

Group I: Brief Motivational interviewing-based Alcohol Intervention (BMAI) Active Control 1 Intervention

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.

Group II: BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4346408/

Brief Alcohol Interventions for Adolescents and Young Adults This study reports findings from a meta-analysis summarizing the effectiveness of brief alcohol interventions for adolescents (age 11-18) and young adults ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797548

Effect of a Novel Brief Motivational Intervention for Alcohol ... Our hypothesis was that participants receiving brief MI would reduce their number of heavy drinking days (HDD) and alcohol-related problems more ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547214001925

Brief Alcohol Interventions for Adolescents and Young Adults Overall, brief alcohol interventions led to significant reductions in alcohol consumption and alcohol-related problems among adolescents ( g ¯ = 0.27 and g ¯ = ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0246652

Developing a brief motivational intervention for young adults ... The authors found 8 studies, including 4 studies comparing MI to standard care among young adults. Three of these showed results favoring MI.

5. psycnet.apa.org psycnet.apa.org/record/2018-41322-006

Brief motivational interviewing intervention to reduce alcohol ... Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: Results of a randomized clinical trial.

6. publications.aap.org publications.aap.org/pediatrics/article/129/6/1083/32208/Brief-Motivational-Interviewing-Intervention-for

Brief Motivational Interviewing Intervention for Peer ... Previous analyses demonstrated that a BI resulted in reductions in violence and alcohol consequences up to 6 months. This article describes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6110093/

Brief motivational interviewing intervention to reduce ... A 15-minute brief motivational interviewing (MI) AOD intervention, delivered in PC, reduced alcohol and marijuana use and consequences.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04450966

Study Details | NCT04450966 | Adolescent Substance Use ... This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling ...