A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
14 september 2026 bijgewerkt door: Boston Medical Center
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
648
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Sarah Bagley, MD, MSc
- Telefoonnummer: (617) 414-7399
- E-mail: sarah.bagley@bmc.org
Studie Contact Back-up
- Naam: Sarah N Kosakowski, MPH
- Telefoonnummer: (617) 414-6906
- E-mail: sarah.kosakowski@bmc.org
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02118
- Boston Medical Center
-
Contact:
- Sarah Bagley, MD
- Telefoonnummer: 617-414-7399
- E-mail: sarah.bagley@bmc.org
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
Providers:
- Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
- ≥ 1 clinic session per week
Youth:
- Ages 13 - 26
- Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
- English speaking
Exclusion Criteria:
Providers:
- Participated as an intervention provider in the R61 pilot RCT (H-45731)
- Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)
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 be able to complete the requirements of the research
- Young adults ages 18-26 with a legal guardian
- Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- Under legal custody of the Department of Children and Families (DCF)
- Participated in the intervention arm of the R61 pilot RCT (H-45731)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention group
Providers randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference.
In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention.
In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment.
|
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 also inform youth participants how to use naloxone and facilitate access if youth would like to have it.
|
|
Actieve vergelijker: Control group
Providers randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual.
|
Youth participants will be provided usual care by providers in the control group.
As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Provider Fidelity to the Intervention
Tijdsspanne: 12 months
|
Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years.
The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.
|
12 months
|
|
Youth Fidelity to the Intervention
Tijdsspanne: 12 months
|
Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments.
The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.
|
12 months
|
|
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months.
|
Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.
|
Baseline, 3 months, 6 months, 9 months, and 12 months.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Youth knowledge of strategies to reduce overdose risk
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months.
|
Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.
|
Baseline, 3 months, 6 months, 9 months, and 12 months.
|
|
Youth's ability to recognize and respond to an overdose
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months.
|
Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.
|
Baseline, 3 months, 6 months, 9 months, and 12 months.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Amy Yule, MD, Boston Medical Center, Psychiatry
- Hoofdonderzoeker: Sarah Bagley, MD, Boston Medical Center, Internal Medicine, Addiction Medicine
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 december 2029
Studie voltooiing (Geschat)
1 december 2029
Studieregistratiedata
Eerst ingediend
27 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 augustus 2026
Eerst geplaatst (Werkelijk)
1 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 september 2026
Laatste update ingediend die voldeed aan QC-criteria
14 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-46999
- R61DA062217 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .