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| ID | Type | Description | Link |
|---|---|---|---|
| R61DA062217 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
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| Control group | Active Comparator | Providers randomized into this arm will deliver usual care to the youth patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief youth overdose prevention education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 weeks, 6-months |
| Youth awareness of strategies to reduce overdose risk |
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Inclusion Criteria for providers:
Exclusion Criteria for providers:
Inclusion criteria for youth:
Exclusion criteria for youth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Bagley, MD MSc | Contact | 617 414 6906 | sarah.bagley@bmc.org | |
| Sarah Kosakowski, MPH | Contact | 617 414 6906 | sarah.kosakowski@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Bagley, MD MSc | Boston Medical Center, Internal Medicine, Addiction Medicine | Principal Investigator |
| Amy Yule, MD | Boston Medical Center, Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center, Pediatric Primary Care & Family Medicine | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Information about Naloxone | Other | Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home. |
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| Usual standard of care | Other | Participants will be provided usual care by providers in the control group. |
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This outcome will be assessed by responses to an investigator developed questionnaire. |
| Baseline, 2 weeks, 6-months |
| Youth's ability to recognize an overdose | This outcome will be assessed by responses to an investigator developed questionnaire. | Baseline, 2 weeks, 6-months |
| Youth's ability to respond to an overdose | This outcome will be assessed by responses to an investigator developed questionnaire. | Baseline, 2 weeks, 6-months |
| D001523 | Mental Disorders |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |