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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT07797933
Status
Not Yet Recruiting

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Conditions

  • Overdose

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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, we propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. We will enroll 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
648 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Provider Fidelity to the Intervention [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Sarah Bagley, MD
[email protected]
617-414-7399

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By research site
Boston Medical Center· Boston, MA

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