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Clinician Practice Companion to Address Youth Substance Use

8 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Practice Companion
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Number of Substance Use Days Reported on the Timeline Follow-Back Interview
Ramy czasowe: 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
Ramy czasowe: Baseline (at the pilot-test visit)
Self-reported overdose experiences in the past 3 months.
Baseline (at the pilot-test visit)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Massachusetts General Hospital

Współpracownicy

National Institute on Drug Abuse (NIDA)
University of British Columbia
Boston Medical Center
Université de Montréal
Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal)

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

1 grudnia 2029

Ukończenie studiów (Szacowany)

1 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2026

Pierwszy wysłany (Rzeczywisty)

24 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024p003521
  • R34DA062280 (Grant/umowa NIH USA)
  • PJT-205890 (Inny numer grantu/finansowania: Canadian Institutes of Health Research)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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