A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-06-30

Brief Summary

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Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone.

This study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.

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Detailed Description

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Conditions

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Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention group

Providers randomized into this arm will complete a 45-minute intervention training. The training will occur either in person or via Zoom teleconference and include overdose prevention education, the pilot brief overdose prevention education intervention, intervention practice, and how to complete the fidelity checklist to be completed at the end of each visit.

Group Type EXPERIMENTAL

Brief youth overdose prevention education

Intervention Type 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.

Information about Naloxone

Intervention Type OTHER

Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.

Control group

Providers randomized into this arm will deliver usual care to the youth patients.

Group Type ACTIVE_COMPARATOR

Usual standard of care

Intervention Type OTHER

Participants will be provided usual care by providers in the control group.

Interventions

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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.

Intervention Type BEHAVIORAL

Information about Naloxone

Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.

Intervention Type OTHER

Usual standard of care

Participants will be provided usual care by providers in the control group.

Intervention Type OTHER

Other Intervention Names

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Narcan

Eligibility Criteria

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Inclusion Criteria

* Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
* ≥ 2 clinic sessions per/week

* Ages 13-26
* Scheduled for a comprehensive physical exam with a provider who is participating in the trial
* English speaking

Exclusion Criteria

* None

* 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
* Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
* Under legal custody of the Department of Children and Families (DCF)

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No