Clinician Practice Companion to Address Youth Substance Use

NCT07725289 | Not Yet Recruiting

• 2 other identifiers: 2024p003521R34DA052836
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey

  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

  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

Secondary Outcomes (3)

• Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver

  Through completion of pilot testing (approximately 18 months)

• Number of Providers Reporting the Practice Companion as Sustainable to Deliver

  Through completion of pilot testing (approximately 18 months)

• Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended

  Through completion of pilot testing (approximately 18 months)

Other Outcomes (2)

• Number of Substance Use Days Reported on the Timeline Follow-Back Interview

  Baseline (at the pilot-test visit)

• Number of Participants Reporting an Overdose in the Past 3 Months

  Baseline (at the pilot-test visit)

Study Arms (1)

Practice Companion

EXPERIMENTAL

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.

Behavioral: Practice Companion

Interventions

Practice Companion BEHAVIORAL

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.

Practice Companion

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 14 to 24 years.
• Uses drugs or alcohol (past year).
• Receiving care at a participating study site.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of British Columbia: collaborator
• Boston Medical Center: collaborator
• Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal): collaborator
• Université de Montréal: collaborator

Study Sites (5)

Adolescent and Young Adult Medicine, Mass General Brigham for Children

Boston, Massachusetts, 02114, United States

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Foundry (Foundry Central Office)

Vancouver, British Columbia, Canada

Location

Centre de Recherche du CHUM (CRCHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22143002 BACKGROUND

• 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.

  PMID: 42127398 BACKGROUND

• 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.

  PMID: 18301133 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Drug Overdose; Marijuana Abuse; Harm Reduction

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Prescription Drug Misuse; Drug Misuse; Behavior

Study Officials

• Danya Fast, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Scott E Hadland, MD, MPH, MS

  Mass General Brigham for Children

  STUDY DIRECTOR

• Nicholas Chadi, MD, MPH

  Université de Montréal / CHU Sainte-Justine

  STUDY DIRECTOR

Central Study Contacts

Danya Fast, PhD

CONTACT

604-875-2345; danya.fast@ubc.ca

Scott E Hadland, MD, MPH, MS

CONTACT

617-724-3873; shadland@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning after overall study completion, with no fixed end date.
• Access Criteria: Open access. The de-identified quantitative dataset and supporting documents will be posted in a publicly accessible data repository.

Locations

US (1); CA (4)