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Clinician Practice Companion to Address Youth Substance Use

8. September 2026 aktualisiert von: Scott Hadland, MD, MPH, MS, Massachusetts General Hospital

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3N1
        • BC Children's Hospital
        • Kontakt:
          • Telefonnummer: 604-875-2345
      • Vancouver, British Columbia, Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1C5
        • CHU Sainte-Justine
        • Kontakt:
          • Telefonnummer: 514-345-4931
      • Montreal, Quebec, Kanada, H2X 0A9
        • Centre de Recherche du CHUM (CRCHUM)
        • Kontakt:
          • Telefonnummer: 514-890-8000
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Adolescent and Young Adult Medicine, Mass General Brigham for Children
        • Kontakt:
          • Telefonnummer: 617-643-1201

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Substance Use Days Reported on the Timeline Follow-Back Interview
Zeitfenster: 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
Zeitfenster: Baseline (at the pilot-test visit)
Self-reported overdose experiences in the past 3 months.
Baseline (at the pilot-test visit)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Danya Fast, PhD, University of British Columbia
  • Studienleiter: Scott E Hadland, MD, MPH, MS, Mass General Brigham for Children
  • Studienleiter: Nicholas Chadi, MD, MPH, Université de Montréal / CHU Sainte-Justine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Dezember 2029

Studienabschluss (Geschätzt)

1. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

20. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant quantitative data (e.g., survey and Timeline Follow-Back data) will be shared. Qualitative interview transcripts will not be shared, given the risk of re-identification within this small population of youth who use substances.

IPD-Sharing-Zeitrahmen

Beginning after overall study completion, with no fixed end date.

IPD-Sharing-Zugriffskriterien

Open access. The de-identified quantitative dataset and supporting documents will be posted in a publicly accessible data repository.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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