A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle

NCT04902391 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6800

Last updated 2025-07-17

No results posted yet for this study

Summary

The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Conditions

  • Mental Health
  • Mental Disorders
  • Pediatrics
  • Emergency Psychiatric

Interventions

OTHER

Health Services

The Acute Mental Health Care Bundle consists of 3 core elements, including: (1) ED triage, (2) ED assessment and care, and (3) follow-up care.

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER
  • University of Saskatchewan

    collaborator OTHER
  • University of Manitoba

    collaborator OTHER
  • McMaster University

    collaborator OTHER
  • Western University, Canada

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • McGill University

    collaborator OTHER
  • Dalhousie University

    collaborator OTHER
  • Memorial University of Newfoundland

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen Freedman, MDCM, MSc · University of Calgary

  • Amanda Newton, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902391 on ClinicalTrials.gov