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Clinician Practice Companion to Address Youth Substance Use

Clinician Practice Companion to Address Youth Substance Use

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07725289
Enrollment
60
Registered
2026-07-24
Start date
2027-01-01
Completion date
2029-12-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Substance Use, Cannabis Use, Co-occurring Mental Health Conditions, Drug Overdose, Opioid Use Disorder, Overdose Prevention, Substance-Related Disorders, Substance Use

Keywords

Adolescents, Young adults, Youth, Substance use, Substance use care, Cannabis, Naloxone, Harm reduction, Take-home drug testing strips, Fentanyl, Medications for opioid use disorder (MOUD), Buprenorphine, Methadone, Overdose prevention, Co-occurring mental health, Youth- and family-centred care, Patient-reported outcomes, Health equity, Implementation science, ADAPT-ITT, Community-based participatory research, Toolkit

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPractice 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of British Columbia
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal)
CollaboratorUNKNOWN
Université de Montréal
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

All pilot-test participants receive care via the single practice companion intervention; there is no comparison or control arm.

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Score on the Experience of Care and Health Outcomes (ECHO) SurveyWithin 1 to 2 weeks after receipt of practice companion-based careYouth-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.
Number of Youth Reporting the Practice Companion as Acceptable, Relevant, Useful, and AppropriateWithin 1 to 2 weeks after receipt of practice companion-based careThemes 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.

Secondary

MeasureTime frameDescription
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to DeliverThrough 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.
Number of Providers Reporting the Practice Companion as Sustainable to DeliverThrough 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.
Percentage of Practice Companion Fidelity Checklist Items Delivered as IntendedThrough 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.

Countries

Canada, United States

Contacts

CONTACTDanya Fast, PhD
danya.fast@ubc.ca604-875-2345
CONTACTScott E Hadland, MD, MPH, MS
shadland@mgh.harvard.edu617-724-3873
PRINCIPAL_INVESTIGATORDanya Fast, PhD

University of British Columbia

STUDY_DIRECTORScott E Hadland, MD, MPH, MS

Mass General Brigham for Children

STUDY_DIRECTORNicholas Chadi, MD, MPH

Université de Montréal / CHU Sainte-Justine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026