RECRUITING

Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care

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Conditions

Adolescent Alcohol UseAlcohol useAlcohol-related problemsDrug useAdolescentMotivational interviewingMindfulnessMindfulness trainingbrief alcohol interventiondigital therapeutic interventionSBIRTPCORI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-09-03
Study Completion:2030-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07059078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 12-17 years old
  2. * Receiving pediatric primary care (PPC) services through the Johns Hopkins Medical Institute healthcare network
  3. * 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)
  4. * Able to speak, understand, and read in English or Spanish
  5. * Able to provide assent, and receiving parental consent/permission to participate.
  1. * 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 \[e.g., psychosis, homicidality, active suicidality, mania\])
  2. * Intellectual Disability (self-, caregiver-, or PPC-reported, or PPC-documented)
  3. * Current or recent specialty substance use disorder treatment in the past 6 months
  4. * Demonstrated current physiological alcohol withdrawal requiring urgent inpatient referral in the judgement of study or PPC physician
  5. * Reported regular opioid, benzodiazepine, or cocaine use (\> weekly) or history of opioid, benzodiazepine, or cocaine overdose in the past 6 months
  6. * Previous experience with a mindfulness-based intervention in the past 12 months
  7. * Current regular meditation practice (\> 30 min/day for \> 5 days avg. over 30 days prior to screening).

Contacts and Locations

Study Contact

Christopher J Hammond, MD, PhD
CONTACT
(410) 550-0144
chammo20@jhmi.edu
Gabrielle Newton, MPH
CONTACT
gnewton3@jh.edu

Principal Investigator

Christopher J Hammond, MD, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Hoover Adger, MD, MPH, MBA
STUDY_DIRECTOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Community Physicians, Remington
Baltimore, Maryland, 21211
United States
Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)
Baltimore, Maryland, 21224
United States
Johns Hopkins Community Physicians, Canton Crossing
Baltimore, Maryland, 21224
United States
Harriet Lane Clinic
Baltimore, Maryland, 21287
United States
Johns Hopkins University Center for Adolescent and Young Adult Health
Baltimore, Maryland, 21287
United States
Johns Hopkins Community Physicians, Water's Edge
Belcamp, Maryland, 21017
United States
Johns Hopkins Community Physicians, Bowie
Bowie, Maryland, 20715
United States
Johns Hopkins Community Physicians, Howard County Pediatrics
Columbia, Maryland, 21046
United States
Johns Hopkins Community Physicians, Glen Burnie
Glen Burnie, Maryland, 20161
United States
Johns Hopkins Community Physicians, Hagerstown
Hagerstown, Maryland, 21742
United States
Johns Hopkins Community Physicians, White Marsh Pediatrics
Nottingham, Maryland, 21236
United States
Johns Hopkins Community Physicians, Odenton Medical
Odenton, Maryland, 21113
United States
Johns Hopkins Community Physicians, Rockville Pediatrics
Rockville, Maryland, 20854
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Christopher J Hammond, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Hoover Adger, MD, MPH, MBA, STUDY_DIRECTOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03
Study Completion Date2030-09-30

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

  • Alcohol use
  • Alcohol-related problems
  • Drug use
  • Adolescent
  • Motivational interviewing
  • Mindfulness
  • Mindfulness training
  • brief alcohol intervention
  • digital therapeutic intervention
  • SBIRT
  • PCORI

Additional Relevant MeSH Terms

  • Adolescent Alcohol Use