Clinician Practice Companion to Address Youth Substance Use
Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States. Many young people who use substances also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care exist, including harm reduction, overdose prevention (such as naloxone and take-home drug testing strips), and medications for addiction treatment. These approaches remain adult-oriented, however, unevenly implemented in youth-serving settings, and insufficiently centered on the needs and goals of youth and their families.
This study develops and pilot tests a written "practice companion" that helps clinicians and other trusted adults provide developmentally appropriate substance use care to youth ages 14 to 24 in hospital and community settings. The practice companion offers practical, easy-to-use guidance organized by substance and by pattern of use. It addresses cannabis and other substances that youth commonly use and that clinicians frequently seek support with, alongside a strong focus on overdose prevention through its core elements: naloxone, take-home drug testing strips, harm reduction education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how gender, sexuality, housing instability, and other social and structural contexts shape substance use and care.
The research team will first interview youth who use substances, their families and caregivers, and clinicians to learn how each element of care should be adapted for young people. The team will then produce the practice companion and pilot test it with 60 youth across three sites, in British Columbia, Québec, and Massachusetts. After receiving care guided by the practice companion, youth will complete an interview about whether the care was relevant, useful, appropriate, and acceptable. Families and clinicians will also be interviewed to assess how feasible, sustainable, and faithful to its design the practice companion is in practice.
Throughout the study, the team will work closely with youth and families who have lived experience through a community-based participatory research approach that includes Community Advisory Boards. The work centers equity for Black, Indigenous, and other racialized youth, Two-Spirit and LGBTQ+ youth, and youth experiencing housing instability. Findings will guide a larger future study of the practice companion's effectiveness.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background and rationale. Substance use, including the use of opioids, cannabis, and other drugs, is common among youth, and overdose has become a leading cause of death among adolescents and young adults in Canada and the United States. Most youth overdose deaths involve illicitly manufactured fentanyl, and the illicit drug supply is increasingly contaminated with benzodiazepines, xylazine, and other novel substances. Approximately two-thirds of youth with a substance use disorder also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care, including harm reduction, overdose prevention interventions (naloxone, take-home drug testing strips, and behavioral strategies), and medications for opioid use disorder (MOUD), remain adult-oriented, unevenly implemented in pediatric and youth-serving settings, and insufficiently centered on the needs and goals of youth and their families. Black, Indigenous, and other racialized youth, Two-Spirit and LGBTQ+ youth, and youth experiencing housing instability face additional barriers to care.
Objective. This three-year, community-engaged project adapts evidence-based substance use care and overdose prevention approaches to the developmental needs of youth and combines them into a single, practical, multi-strategy practice companion for clinicians and other trusted adults working in acute (e.g., hospital) and community (e.g., drop-in clinic) settings. Practice companion content is organized by substance and by pattern of use and addresses cannabis and other substances that youth commonly use, in addition to opioids; overdose prevention remains a core component. The practice companion also attends to co-occurring mental health needs and to how gender, sexuality, poverty, and housing instability intersect with substance use and care. The work lays the groundwork for a larger hybrid effectiveness-implementation study of the practice companion.
Conceptual framework. The project follows the ADAPT-ITT implementation science framework, focusing on the Adaptation, Production, and Testing phases, and uses a community-based participatory research approach that centers equity-owed youth and families (biological, adoptive, and chosen) at every stage. Youth and caregivers with lived experience contribute throughout via six Community Advisory Boards (one youth and one caregiver board at each of the three sites).
Objective. Trained clinicians and other providers deliver care via the practice companion to 60 youth (20 per site). After receiving care, youth complete a qualitative exit interview and a brief quantitative survey assessing acceptability. Interviews with 30 caregivers (10 per site) and the 12 practice companion-delivering providers further assess feasibility, sustainability, and fidelity. Plan-Do-Study-Act cycles guide continuous optimization, producing final site-specific versions of the practice companion for a future, larger study.
Sites and settings. British Columbia: BC Children's Hospital and Foundry (a provincial network of integrated youth services centres). Québec: CHU Sainte-Justine (Substance Use and Addiction Program and Gender Diversity Clinic) and the CRCHUM. Massachusetts: the Adolescent and Young Adult Clinic at Mass General Brigham for Children.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Danya Fast, PhD
- Número de teléfono: 604-875-2345
- Correo electrónico: danya.fast@ubc.ca
Copia de seguridad de contactos de estudio
- Nombre: Scott E Hadland, MD, MPH, MS
- Número de teléfono: 617-724-3873
- Correo electrónico: shadland@mgh.harvard.edu
Ubicaciones de estudio
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V6H 3N1
- BC Children's Hospital
-
Contacto:
- Número de teléfono: 604-875-2345
-
Vancouver, British Columbia, Canadá
- Foundry (Foundry Central Office)
-
Contacto:
- Correo electrónico: info@foundrybc.ca
-
-
Quebec
-
Montreal, Quebec, Canadá, H3T 1C5
- CHU Sainte-Justine
-
Contacto:
- Número de teléfono: 514-345-4931
-
Montreal, Quebec, Canadá, H2X 0A9
- Centre de Recherche du CHUM (CRCHUM)
-
Contacto:
- Número de teléfono: 514-890-8000
-
-
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Adolescent and Young Adult Medicine, Mass General Brigham for Children
-
Contacto:
- Número de teléfono: 617-643-1201
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Ages 14 to 24 years.
- Uses drugs or alcohol (past year).
- Receiving care at a participating study site.
Exclusion Criteria:
- Cognitive limitations or intellectual disabilities that prevent provision of informed consent.
- Any medical or psychiatric condition causing acute distress or requiring emergency evaluation.
- Current membership on a study Community Advisory Board.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Practice Companion
Youth ages 14 to 24 who use substances receive developmentally appropriate substance use care from a clinician (or other trained provider) using the practice companion.
Depending on individual needs, the provider offers guidance across the practice companion's elements, including overdose prevention (naloxone, take-home drug testing strips, harm reduction education, and medications for addiction treatment), support around cannabis and other substance use, and attention to co-occurring mental health, delivered through non-stigmatizing, youth- and family-centered scripts and referral guidance.
|
A written, multi-strategy practice companion that guides clinicians and other trusted adults in acute and community settings to deliver developmentally appropriate substance use care to youth.
Content is organized by substance and by pattern of use.
It includes scripts for initiating non-stigmatizing conversations and guidance and referrals for connecting youth and families to care, spanning cannabis and other substance use, overdose prevention as a core component (naloxone, take-home drug testing strips, harm reduction education, and medications for opioid use disorder), and co-occurring mental health needs.
The practice companion is youth- and family-centered and attends to how gender, sexuality, poverty, and housing instability intersect with substance use.
Site-specific adaptations are provided for the British Columbia, Québec, and Massachusetts settings.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
Periodo de tiempo: Within 1 to 2 weeks after receipt of practice companion-based care
|
Youth-reported acceptability of care received via the practice companion, measured with the ECHO Survey, a validated patient-reported experience measure, administered after receipt of practice companion-based care.
|
Within 1 to 2 weeks after receipt of practice companion-based care
|
|
Number of Youth Reporting the Practice Companion as Acceptable, Relevant, Useful, and Appropriate
Periodo de tiempo: Within 1 to 2 weeks after receipt of practice companion-based care
|
Themes on the relevance, usefulness, appropriateness, and overall acceptability of practice companion content and delivery, derived from semi-structured qualitative exit interviews with youth following receipt of care via the practice companion.
|
Within 1 to 2 weeks after receipt of practice companion-based care
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
Periodo de tiempo: Through completion of pilot testing (approximately 18 months)
|
Themes on the feasibility of delivering the practice companion in acute and community care settings, from qualitative interviews with caregivers and practice companion-delivering clinicians.
|
Through completion of pilot testing (approximately 18 months)
|
|
Number of Providers Reporting the Practice Companion as Sustainable to Deliver
Periodo de tiempo: Through completion of pilot testing (approximately 18 months)
|
Themes on the sustainability of practice companion delivery, from qualitative interviews with clinicians and Community Advisory Board input.
|
Through completion of pilot testing (approximately 18 months)
|
|
Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended
Periodo de tiempo: Through completion of pilot testing (approximately 18 months)
|
Fidelity of practice companion delivery, assessed by intervention-delivering clinicians using a standardized fidelity checklist reviewed at 3-to-4-month intervals.
|
Through completion of pilot testing (approximately 18 months)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Substance Use Days Reported on the Timeline Follow-Back Interview
Periodo de tiempo: Baseline (at the pilot-test visit)
|
Self-reported substance use patterns measured with the Timeline Follow-Back interview.
|
Baseline (at the pilot-test visit)
|
|
Number of Participants Reporting an Overdose in the Past 3 Months
Periodo de tiempo: Baseline (at the pilot-test visit)
|
Self-reported overdose experiences in the past 3 months.
|
Baseline (at the pilot-test visit)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Danya Fast, PhD, University of British Columbia
- Director de estudio: Scott E Hadland, MD, MPH, MS, Mass General Brigham for Children
- Director de estudio: Nicholas Chadi, MD, MPH, Université de Montréal / CHU Sainte-Justine
Publicaciones y enlaces útiles
Publicaciones Generales
- Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1.
- Hadland SE, Wood E, Levy S. How the paediatric workforce can address the opioid crisis. Lancet. 2016 Sep 24;388(10051):1260-1. doi: 10.1016/S0140-6736(16)31573-2. No abstract available.
- Hjorthoj CR, Hjorthoj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26.
- Daniels AS, Shaul JA, Greenberg P, Cleary PD. The Experience of Care and Health Outcomes Survey (ECHO): A Consumer Survey to Collect Ratings of Behavioral Health Care Treatment, Outcomes and Plans. In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, Volume 3: Instruments for Adults. 3rd ed. Mahwah, NJ: Lawrence Erlbaum Associates; 2004.
- Thulien M, Anderson H, Douglas S, Dykeman R, Horne A, Howard B, Sedgemore K, Charlesworth R, Fast D. The generative potential of mess in community-based participatory research with young people who use(d) drugs in Vancouver. Harm Reduct J. 2022 Mar 25;19(1):30. doi: 10.1186/s12954-022-00615-7.
- Fast D. Going Nowhere: Ambivalence about Drug Treatment during an Overdose Public Health Emergency in Vancouver. Med Anthropol Q. 2021 Jun;35(2):209-225. doi: 10.1111/maq.12638. Epub 2021 Apr 18.
- Hadland SE, Burr WH, Zoucha K, Somberg CA, Camenga DR. Treating Adolescent Opioid Use Disorder in Primary Care. JAMA Pediatr. 2024 Apr 1;178(4):414-416. doi: 10.1001/jamapediatrics.2023.6493.
- Hadland SE, Bagley SM, Rodean J, Silverstein M, Levy S, Larochelle MR, Samet JH, Zima BT. Receipt of Timely Addiction Treatment and Association of Early Medication Treatment With Retention in Care Among Youths With Opioid Use Disorder. JAMA Pediatr. 2018 Nov 1;172(11):1029-1037. doi: 10.1001/jamapediatrics.2018.2143.
- Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan Z, Bagley SM, Liebschutz JM, Walley AY. Medication for Opioid Use Disorder After Nonfatal Opioid Overdose and Association With Mortality: A Cohort Study. Ann Intern Med. 2018 Aug 7;169(3):137-145. doi: 10.7326/M17-3107. Epub 2018 Jun 19.
- Friedman J, Godvin M, Shover CL, Gone JP, Hansen H, Schriger DL. Trends in Drug Overdose Deaths Among US Adolescents, January 2010 to June 2021. JAMA. 2022 Apr 12;327(14):1398-1400. doi: 10.1001/jama.2022.2847.
- Raymond-King C, Jeffery MM, Melnick ER. Current Causes of Death among Children and Adolescents in the United States. N Engl J Med. 2026 May 14;394(19):1958-1959. doi: 10.1056/NEJMc2600445. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Adolescentes
- Metadona
- Fentanilo
- Canabis
- Adultos jovenes
- Naloxona
- Buprenorfina
- Juventud
- Prevención de sobredosis
- Resultados informados por el paciente
- Uso de sustancias
- Reducción de daños
- Investigación participativa basada en la comunidad
- Ciencia de implementación
- Caja de herramientas
- Equidad en salud
- ADAPT-ITT
- Medicamentos para el trastorno por consumo de opioides (MOUD)
- Substance use care
- Take-home drug testing strips
- Co-occurring mental health
- Youth- and family-centred care
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024p003521
- R34DA062280 (Subvención/contrato del NIH de EE. UU.)
- PJT-205890 (Otro número de subvención/financiamiento: Canadian Institutes of Health Research)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .