- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07725289
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Danya Fast, PhD
- Numero di telefono: 604-875-2345
- Email: danya.fast@ubc.ca
Backup dei contatti dello studio
- Nome: Scott E Hadland, MD, MPH, MS
- Numero di telefono: 617-724-3873
- Email: shadland@mgh.harvard.edu
Luoghi di studio
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- BC Children's Hospital
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Contatto:
- Numero di telefono: 604-875-2345
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Vancouver, British Columbia, Canada
- Foundry (Foundry Central Office)
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Contatto:
- Email: info@foundrybc.ca
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine
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Contatto:
- Numero di telefono: 514-345-4931
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Montreal, Quebec, Canada, H2X 0A9
- Centre de Recherche du CHUM (CRCHUM)
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Contatto:
- Numero di telefono: 514-890-8000
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Adolescent and Young Adult Medicine, Mass General Brigham for Children
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Contatto:
- Numero di telefono: 617-643-1201
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
Lasso di tempo: Within 1 to 2 weeks after receipt of practice companion-based care
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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.
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Within 1 to 2 weeks after receipt of practice companion-based care
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Number of Youth Reporting the Practice Companion as Acceptable, Relevant, Useful, and Appropriate
Lasso di tempo: Within 1 to 2 weeks after receipt of practice companion-based care
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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.
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Within 1 to 2 weeks after receipt of practice companion-based care
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
Lasso di tempo: Through completion of pilot testing (approximately 18 months)
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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.
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Through completion of pilot testing (approximately 18 months)
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Number of Providers Reporting the Practice Companion as Sustainable to Deliver
Lasso di tempo: Through completion of pilot testing (approximately 18 months)
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Themes on the sustainability of practice companion delivery, from qualitative interviews with clinicians and Community Advisory Board input.
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Through completion of pilot testing (approximately 18 months)
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Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended
Lasso di tempo: Through completion of pilot testing (approximately 18 months)
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Fidelity of practice companion delivery, assessed by intervention-delivering clinicians using a standardized fidelity checklist reviewed at 3-to-4-month intervals.
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Through completion of pilot testing (approximately 18 months)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Substance Use Days Reported on the Timeline Follow-Back Interview
Lasso di tempo: Baseline (at the pilot-test visit)
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Self-reported substance use patterns measured with the Timeline Follow-Back interview.
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Baseline (at the pilot-test visit)
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Number of Participants Reporting an Overdose in the Past 3 Months
Lasso di tempo: Baseline (at the pilot-test visit)
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Self-reported overdose experiences in the past 3 months.
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Baseline (at the pilot-test visit)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Danya Fast, PhD, University of British Columbia
- Direttore dello studio: Scott E Hadland, MD, MPH, MS, Mass General Brigham for Children
- Direttore dello studio: Nicholas Chadi, MD, MPH, Université de Montréal / CHU Sainte-Justine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Adolescenti
- Metadone
- Fentanil
- Cannabis
- Giovani adulti
- Nalossone
- Buprenorfina
- Gioventù
- Prevenzione dell'overdose
- Risultati riferiti dal paziente
- Uso di sostanze
- Riduzione del danno
- Ricerca partecipativa basata sulla comunità
- Scienza dell'implementazione
- Kit di strumenti
- Equità sanitaria
- ADAPT-ITT
- Farmaci per il disturbo da uso di oppioidi (MOUD)
- Substance use care
- Take-home drug testing strips
- Co-occurring mental health
- Youth- and family-centred care
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024p003521
- R34DA062280 (Sovvenzione/contratto NIH degli Stati Uniti)
- PJT-205890 (Altro numero di sovvenzione/finanziamento: Canadian Institutes of Health Research)
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- ICF
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