RECRUITING

A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-25
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07022717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sarah Bagley, MD MSc
CONTACT
617 414 6906
sarah.bagley@bmc.org
Ally Cogan, MPH
CONTACT
617 414 6906
ally.cogan@bmc.org

Principal Investigator

Sarah Bagley, MD MSc
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Internal Medicine, Addiction Medicine
Amy Yule, MD
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Psychiatry

Study Locations (Sites)

Boston Medical Center, Pediatric Primary Care & Family Medicine
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Sarah Bagley, MD MSc, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Internal Medicine, Addiction Medicine
  • Amy Yule, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-08-25
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Brief overdose prevention
  • Naloxone
  • Youth patients
  • Health care providers
  • Primary care

Additional Relevant MeSH Terms

  • Overdose