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

NCT07797933 | Not Yet Recruiting DMC

• 2 other identifiers: H-46999R61DA062217
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overdose

Keywords

Brief overdose prevention; Naloxone; Youth parents; Health care providers; Primary care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Youth knowledge of strategies to reduce overdose risk

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Youth's ability to recognize and respond to an overdose

  Baseline, 3 months, 6 months, 9 months, and 12 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Brief youth overdose prevention education BEHAVIORAL

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.

Intervention group

Usual Standard of Care OTHER

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.

Control group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sarah Bagley, MD

  Boston Medical Center, Internal Medicine, Addiction Medicine

  PRINCIPAL INVESTIGATOR

• Amy Yule, MD

  Boston Medical Center, Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Bagley, MD, MSc

CONTACT

(617) 414-7399; sarah.bagley@bmc.org

Sarah N Kosakowski, MPH

CONTACT

(617) 414-6906; sarah.kosakowski@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm cluster RCT will be conducted. Randomization will occur at the provider level. After enrollment, a 2-block randomization will be done to ensure that randomization to the intervention is balanced across provider types (e.g., family medicine vs. pediatrics). .

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)