Clinician Practice Companion to Address Youth Substance Use

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-24
SponsorMassachusetts General Hospital

About this trial

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 overdose prevention and safety strategies (such as naloxone) 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, other safety strategies, overdose prevention and safety education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how poverty, housing instability, and other social circumstances shape substance use and access to 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. Findings will guide a larger future study of the practice companion's effectiveness.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages 14 to 24 years.

Uses drugs or alcohol (past year).

Receiving care at a participating study site.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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, other safety strategies, overdose prevention and safety 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 poverty and housing instability shape substance use and access to care. Site-specific adaptations are provided for the British Columbia, Québec, and Massachusetts settings.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Practice CompanionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 1 to 2 weeks after receipt of practice companion-based care
2

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.

Time frame
Within 1 to 2 weeks after receipt of practice companion-based care

Secondary outcomes

1

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.

Time frame
Through completion of pilot testing (approximately 18 months)
2

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.

Time frame
Through completion of pilot testing (approximately 18 months)
3

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.

Time frame
Through completion of pilot testing (approximately 18 months)

Other outcomes

1

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

Self-reported substance use patterns measured with the Timeline Follow-Back interview.

Time frame
Baseline (at the pilot-test visit)
2

Number of Participants Reporting an Overdose in the Past 3 Months

Self-reported overdose experiences in the past 3 months.

Time frame
Baseline (at the pilot-test visit)

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

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

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