A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3

Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.

To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.

Study Overview

• Status: Not yet recruiting
• Conditions: Overdose
• Intervention / Treatment: Behavioral: Brief youth overdose prevention education; Other: Usual Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 648
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Bagley, MD, MSc; Phone Number: (617) 414-7399; Email: sarah.bagley@bmc.org
• Study Contact Backup: Name: Sarah N Kosakowski, MPH; Phone Number: (617) 414-6906; Email: sarah.kosakowski@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
      • Contact: Sarah Bagley, MD; Phone Number: 617-414-7399; Email: sarah.bagley@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Providers:

• Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
• ≥ 1 clinic session per week

Youth:

• Ages 13 - 26
• Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
• English speaking

Exclusion Criteria:

Providers:

• Participated as an intervention provider in the R61 pilot RCT (H-45731)
• Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)

Youth:

• Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking
• Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research
• Young adults ages 18-26 with a legal guardian
• Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
• Under legal custody of the Department of Children and Families (DCF)
• Participated in the intervention arm of the R61 pilot RCT (H-45731)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Providers randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference. In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention. In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment.	Behavioral: Brief youth overdose prevention education; Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it.
Active Comparator: Control group; Providers randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual.	Other: Usual Standard of Care; Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Fidelity to the Intervention	Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.	12 months
Youth Fidelity to the Intervention	Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.	12 months
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs	Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.	Baseline, 3 months, 6 months, 9 months, and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Youth knowledge of strategies to reduce overdose risk	Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.	Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth's ability to recognize and respond to an overdose	Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.	Baseline, 3 months, 6 months, 9 months, and 12 months.

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Amy Yule, MD, Boston Medical Center, Psychiatry; Principal Investigator: Sarah Bagley, MD, Boston Medical Center, Internal Medicine, Addiction Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Primary care; Naloxone; Health care providers; Brief overdose prevention; Youth parents
• Additional Relevant MeSH Terms: Drug Misuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Drug Overdose
• Other Study ID Numbers: H-46999; R61DA062217 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No