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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

13 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

648 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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. Twenty-four providers and 624 youth patient participants randomized (at the provider level) will be enrolled to receive either the brief overdose prevention intervention or usual care will be enrolled.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Providers:

• Physicians and advanced 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 comprehensive physical exam (CPE) or follow-up clinical appointment with a provider who is participating in the trial
• English or Spanish 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)

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Boston Medical Center

Study start

2026-11 Estimated

Primary completion

2029-08 Estimated

Study completion

2029-08 Estimated

First posted

Sep 1, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts