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Not yet recruiting NCT07725289

Clinician Practice Companion to Address Youth Substance Use

No phase Interventional Substance Use Substance-Related Disorders Adolescent Substance Use Cannabis Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Practice Companion.
Who it may be relevant to
Registry conditions: Substance Use, Substance-Related Disorders, Adolescent Substance Use, Cannabis Use. Basic parameters: 14 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral 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 testi

Primary outcome measures

  • Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey [Time frame: 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 [Time frame: Within 1 to 2 weeks after receipt of practice companion-based care]
Secondary outcome measures (3)
  • Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver [Time frame: Through completion of pilot testing (approximately 18 months)]
  • Number of Providers Reporting the Practice Companion as Sustainable to Deliver [Time frame: Through completion of pilot testing (approximately 18 months)]
  • Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended [Time frame: Through completion of pilot testing (approximately 18 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 4 centers
  • BC Children's Hospital — Vancouver
  • Foundry (Foundry Central Office) — Vancouver
  • Centre de Recherche du CHUM (CRCHUM) — Montreal
  • CHU Sainte-Justine — Montreal
United States · 1 center
  • Adolescent and Young Adult Medicine, Mass General Brigham for Children — Boston

Publications

  • 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. PMID 35337350
  • 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. PMID 33866590
  • 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. PMID 38407892
  • 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. PMID 30208470
  • 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. PMID 27673455
  • 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. PMID 29913516
  • 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. PMID 35412573

Identifiers

NCT: NCT07725289 · 2024p003521 · R34DA052836

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗