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Clinician Practice Companion to Address Youth Substance Use

2026年9月8日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Adolescent and Young Adult Medicine, Mass General Brigham for Children
        • コンタクト:
          • 電話番号:617-643-1201
    • British Columbia
      • Vancouver、British Columbia、カナダ、V6H 3N1
        • BC Children's Hospital
        • コンタクト:
          • 電話番号:604-875-2345
      • Vancouver、British Columbia、カナダ
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1C5
        • CHU Sainte-Justine
        • コンタクト:
          • 電話番号:514-345-4931
      • Montreal、Quebec、カナダ、H2X 0A9
        • Centre de Recherche du CHUM (CRCHUM)
        • コンタクト:
          • 電話番号:514-890-8000

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
時間枠: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
時間枠: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
時間枠: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)

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Substance Use Days Reported on the Timeline Follow-Back Interview
時間枠: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
時間枠:Baseline (at the pilot-test visit)
Self-reported overdose experiences in the past 3 months.
Baseline (at the pilot-test visit)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Danya Fast, PhD、University of British Columbia
  • スタディディレクター:Scott E Hadland, MD, MPH, MS、Mass General Brigham for Children
  • スタディディレクター:Nicholas Chadi, MD, MPH、Université de Montréal / CHU Sainte-Justine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2029年12月1日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2026年7月20日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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