NCT07022717

A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overdose

Interventions

Type	Name	Description
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.
OTHER	Information about Naloxone	Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.
OTHER	Usual standard of care	Participants will be provided usual care by providers in the control group.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-15
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States