A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk
ConditionOverdose
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
≥ 2 clinic sessions per/week
Disqualifiers
None
Ages 13-26
Scheduled for a comprehensive physical exam with a provider who is participating in the trial
English speaking
Trial design
Design model
Parallel
Treatments tested in this trial
Brief youth overdose prevention education
BehavioralProviders 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.
Information about Naloxone
Other interventionProviders in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.
Usual standard of care
Other interventionParticipants will be provided usual care by providers in the control group.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the brief overdose prevention education intervention
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 months2
Provider acceptability of the brief overdose prevention education intervention
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 months3
Youth acceptability of the brief overdose prevention education intervention
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
6 monthsSecondary outcomes
1
Youth perception of risk associated with fentanyl and other emerging drugs
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-months2
Youth awareness of strategies to reduce overdose risk
This outcome will be assessed by responses to an investigator developed questionnaire.
Time frame
Baseline, 2 weeks, 6-months3
Youth's ability to recognize an overdose
This outcome will be assessed by responses to an investigator developed questionnaire.
Time frame
Baseline, 2 weeks, 6-months4
Youth's ability to respond to an overdose
This outcome will be assessed by responses to an investigator developed questionnaire.
Time frame
Baseline, 2 weeks, 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov