Boston Medical Center, Pediatric Primary Care & Family Medicine
Boston, Massachusetts, 02118, United States
Location status: Recruiting
NCT Number: NCT07022717
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.
Interested in participating?
Request Info13 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for providers:
Exclusion criteria
for providers:
Inclusion criteria
for youth:
Exclusion criteria
for youth:
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.
Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.
Other names: Narcan
Participants will be provided usual care by providers in the control group.
Time frame: 6 months
Providers in the intervention arm will complete a checklist after all comprehensive physical exams with youth ages 13 to 26 years. The checklist will assess which components of the intervention the provider was able to deliver during the visit.
Time frame: 6 months
Providers in the intervention group will complete 8 questions based on the Theoretical Framework of Acceptability (TFA) acceptability questionnaire on a 5-point Likert scale. The measure will be collected post-intervention training and after all youth have received the intervention
Time frame: 6 months
Youth participants receiving care from providers in the interventions group will be asked after their comprehensive physical exam questions from an investigator developed questionnaire to rate their experience of the visit, receipt of the brief youth overdose prevention education intervention, importance, relevance, and comfort with the information.
Time frame: Baseline, 2 weeks, 6-months
A question assessing "Risk of taking medication you weren't prescribed" on a 3-point Likert scale adapted from the Monitoring the Future (MTF) survey
Time frame: Baseline, 2 weeks, 6-months
This outcome will be assessed by responses to an investigator developed questionnaire.
Time frame: Baseline, 2 weeks, 6-months
This outcome will be assessed by responses to an investigator developed questionnaire.
Time frame: Baseline, 2 weeks, 6-months
This outcome will be assessed by responses to an investigator developed questionnaire.
Contact information is provided by the study sponsor or research team.
Sarah Bagley, MD MSc
CONTACT
Sarah Kosakowski, MPH
CONTACT
Boston Medical Center
Other
A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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