A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
Overdose
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 13 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 648 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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. Twenty-four providers and 624 youth patient participants randomized (at the provider level) will be enrolled to receive either the brief overdose prevention intervention or usual care will be enrolled.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
Providers:
- Physicians and advanced 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 comprehensive physical exam (CPE) or follow-up clinical appointment with a provider who is participating in the trial
- English or Spanish 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)
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Intervention group
Providers randomized to the intervention group will complete two 30-minute trainings in person or 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.
Behavioral: Brief youth overdose prevention education
Control group
Providers randomized to the control group will provide usual care to youth during comprehensive physical exam (CPE) or follow-up clinical appointments.
Other: Usual Standard of Care
Brief youth overdose prevention education BEHAVIORAL
Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also educate youth participants on naloxone use and provide assistance with accessing naloxone.
Usual Standard of Care OTHER
Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may educate youth participants on naloxone use and provide assistance with accessing naloxone.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Plazo: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using a 4-point Likert-scale question adapted from the Monitoring the Future (MTF) survey measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed. Possible scores range from 1 (no risk) to 4 (great risk), with higher scores indicating greater perceived risk of harm (a better outcome).
Medidas secundarias
Youth knowledge of strategies to reduce overdose risk
Plazo: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using 4-point Likert-scale questions adapted from the Monitoring the Future (MTF) survey measuring perceived risk associated with using more than one substance at a time and using substances while alone. Possible scores range from 1 (no risk) to 4 (great risk), with higher scores indicating greater perceived risk of harm (a better outcome).
Youth's ability to recognize an overdose
Plazo: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using questions adapted from the Opioid Overdose Knowledge Scale (OOKS) evaluating participants' ability to identify signs of an opioid overdose.
Youth's ability to respond to an overdose
Plazo: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using a question adapted from the Opioid Overdose Knowledge Scale (OOKS) evaluating participants' knowledge of steps in opioid overdose response.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Boston Medical CenterBoston, Massachusetts, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Boston Medical Center
- Inicio del estudio
- 2026-11 Estimado
- Finalización primaria
- 2029-08 Estimado
- Finalización del estudio
- 2029-08 Estimado
- Primera publicación
- 1 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026