Purpose

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.

Condition

Eligibility

Eligible Ages
Over 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

for providers: - None Inclusion criteria for youth: - Ages 13-26 - Scheduled for a comprehensive physical exam with a provider who is participating in the trial - English speaking Exclusion criteria for 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 - Any medical/psychiatric condition that causes acute distress and requires emergency evaluation - Under legal custody of the Department of Children and Families (DCF)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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 names:
    • Narcan
Active Comparator
Control group
Providers randomized into this arm will deliver usual care to the youth patients.
  • Other: Usual standard of care
    Participants will be provided usual care by providers in the control group.

Recruiting Locations

Boston Medical Center, Pediatric Primary Care & Family Medicine
Boston 4930956, Massachusetts 6254926 02118
Contact:
Sarah Bagley, MD MSc
617-414-6906
sarah.bagley@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Sarah Bagley, MD MSc
617 414 6906
sarah.bagley@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.