[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725289":3,"trial-entities:NCT07725289":201,"trial-summary:NCT07725289":206},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":26,"study_type":49,"primary_purpose":50,"phases":51,"enrollment_info":53,"interventions":56,"primary_outcomes":62,"secondary_outcomes":70,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":95,"locations":98,"central_contacts":148,"overall_officials":156,"references":166,"see_also_links":200},"NCT07725289","2024p003521","Clinician Practice Companion to Address Youth Substance Use","NOT_YET_RECRUITING","2029-12","2026-07","2026-07-27","2027-01","Massachusetts General Hospital","OTHER",false,"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.\n\nThis 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.\n\nThe 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.\n\nThroughout 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.","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.\n\nObjective. 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.\n\nConceptual 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).\n\nObjective. 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.\n\nSites 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.",[18,19,20,21,22,23,24,25],"Substance Use","Substance-Related Disorders","Adolescent Substance Use","Cannabis Use","Opioid Use Disorder","Drug Overdose","Overdose Prevention","Co-occurring Mental Health Conditions",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"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","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[52],"NA",{"count":54,"type":55},60,"ESTIMATED",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61},"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 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.",[59],[63,67],{"measure":64,"description":65,"timeFrame":66},"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",{"measure":68,"description":69,"timeFrame":66},"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.",[71,75,78],{"measure":72,"description":73,"timeFrame":74},"Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver","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)",{"measure":76,"description":77,"timeFrame":74},"Number of Providers Reporting the Practice Companion as Sustainable to Deliver","Themes on the sustainability of practice companion delivery, from qualitative interviews with clinicians and Community Advisory Board input.",{"measure":79,"description":80,"timeFrame":74},"Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended","Fidelity of practice companion delivery, assessed by intervention-delivering clinicians using a standardized fidelity checklist reviewed at 3-to-4-month intervals.","ALL","14 Years","24 Years",true,{"inclusion":86,"exclusion":90,"raw_text":94},[87,88,89],"Ages 14 to 24 years.","Uses drugs or alcohol (past year).","Receiving care at a participating study site.",[91,92,93],"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.","Inclusion Criteria:\n\n* Ages 14 to 24 years.\n* Uses drugs or alcohol (past year).\n* Receiving care at a participating study site.\n\nExclusion Criteria:\n\n* Cognitive limitations or intellectual disabilities that prevent provision of informed consent.\n* Any medical or psychiatric condition causing acute distress or requiring emergency evaluation.\n* Current membership on a study Community Advisory Board.",[96,97],"CHILD","ADULT",[99,112,124,130,141],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":109},"Adolescent and Young Adult Medicine, Mass General Brigham for Children","Boston","Massachusetts","02114","United States",[106],{"role":107,"phone":108},"CONTACT","617-643-1201",{"lat":110,"lon":111},42.35843,-71.05977,{"facility":113,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":121},"BC Children's Hospital","Vancouver","British Columbia","V6H 3N1","Canada",[119],{"role":107,"phone":120},"604-875-2345",{"lat":122,"lon":123},49.24966,-123.11934,{"facility":125,"city":114,"state":115,"country":117,"contacts":126,"geoPoint":129},"Foundry (Foundry Central Office)",[127],{"role":107,"email":128},"info@foundrybc.ca",{"lat":122,"lon":123},{"facility":131,"city":132,"state":133,"zip":134,"country":117,"contacts":135,"geoPoint":138},"Centre de Recherche du CHUM (CRCHUM)","Montreal","Quebec","H2X 0A9",[136],{"role":107,"phone":137},"514-890-8000",{"lat":139,"lon":140},45.50884,-73.58781,{"facility":142,"city":132,"state":133,"zip":143,"country":117,"contacts":144,"geoPoint":147},"CHU Sainte-Justine","H3T 1C5",[145],{"role":107,"phone":146},"514-345-4931",{"lat":139,"lon":140},[149,152],{"name":150,"role":107,"phone":120,"email":151},"Danya Fast, PhD","danya.fast@ubc.ca",{"name":153,"role":107,"phone":154,"email":155},"Scott E Hadland, MD, MPH, MS","617-724-3873","shadland@mgh.harvard.edu",[157,160,163],{"name":150,"affiliation":158,"role":159},"University of British Columbia","PRINCIPAL_INVESTIGATOR",{"name":153,"affiliation":161,"role":162},"Mass General Brigham for Children","STUDY_DIRECTOR",{"name":164,"affiliation":165,"role":162},"Nicholas Chadi, MD, MPH","Université de Montréal \u002F CHU Sainte-Justine",[167,170,173,176,179,182,185,188,191,194,197],{"type":168,"citation":169},"BACKGROUND","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.",{"pmid":171,"type":168,"citation":172},"35337350","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\u002Fs12954-022-00615-7.",{"pmid":174,"type":168,"citation":175},"33866590","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\u002Fmaq.12638. Epub 2021 Apr 18.",{"pmid":177,"type":168,"citation":178},"38407892","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\u002Fjamapediatrics.2023.6493.",{"pmid":180,"type":168,"citation":181},"30208470","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\u002Fjamapediatrics.2018.2143.",{"pmid":183,"type":168,"citation":184},"27673455","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\u002FS0140-6736(16)31573-2. No abstract available.",{"pmid":186,"type":168,"citation":187},"29913516","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\u002FM17-3107. Epub 2018 Jun 19.",{"pmid":189,"type":168,"citation":190},"35412573","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\u002Fjama.2022.2847.",{"pmid":192,"type":168,"citation":193},"22143002","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\u002Fj.addbeh.2011.11.025. Epub 2011 Nov 26.",{"pmid":195,"type":168,"citation":196},"42127398","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\u002FNEJMc2600445. No abstract available.",{"pmid":198,"type":168,"citation":199},"18301133","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\u002FQAI.0b013e3181605df1.",[],{"nct_id":4,"conditions":202,"biomarkers":205},[203,25,22,204,18],"Cannabis misuse","Overdose",[],{"nct_id":4,"found":84,"summary":207,"prompt_version":217},{"design":208,"status":209,"heading":210,"summary":211,"follow_up":212,"word_count":213,"commitments":214,"compensation":215,"drugs_mentioned":216},"This study is interventional and plans to enroll 60 participants. It is testing a behavioral intervention.","completed","Study of a Practice Companion for Youth Substance Use","This study is testing a \"Practice Companion,\" which is a written guide for clinicians and other trusted adults. This guide helps them provide care for young people (ages 14-24) who use substances like opioids and cannabis. The goal is to make sure this care is right for young people's needs and goals. Researchers want to see if the Practice Companion helps improve the experience of care for youth and if young people find it acceptable, useful, and appropriate. This study plans to include 60 participants and is currently unclear on its recruitment status.","Participants will be assessed within 1 to 2 weeks after receiving care based on the practice companion.",93,"Not specified in the trial record.","Not stated in the trial record.",[59],"v2"]