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Clinical Trials in Canada / NCT04902391
Active, not recruiting Not applicable

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

NCT04902391 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-02-09
Last updated
2025-07-17

Condition(s) studied

Mental HealthMental DisordersPediatricsEmergency Psychiatric

Investigational drug(s) / intervention(s)

Health Services

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.

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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 8 to 17.99 years 2. Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories: 1. Anxiety/situational crisis and/or hyperventilation 2. Bizarre/paranoid behaviour 3. Concern for patient's welfare 4. Depression/suicidal/deliberate self-harm 5. Hallucinations/delusions 6. Violent/homicidal behaviour 7. Insomnia 8. Pediatric disruptive behaviour Exclusion Criteria: 1. Brought to the ED under provincial mental health legislation 2. Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion) 3. Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.) 4. Other co-morbid medical concerns requiring oversight and/or medical clearance from an emergency physician (e.g., confusion/disorientation, substance withdrawal, other medical complaints, etc.) 5. Substance misuse/intoxication or altered level of consciousness 6. Exhibiting a behavioural syndrome associated with physiologic disturbances (e.g., anorexia) Children/youth will also be excluded based on language barriers: 7. Language barrier (i.e., patient and parent/legal guardian must be fluent in either English or French)

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
The Children's Hospital of Winnipeg Winnipeg Manitoba
Janeway Children's Hospital St. John's Newfoundland and Labrador
IWK Health Centre Halifax Nova Scotia
McMaster Children's Hospital Hamilton Ontario
London Health Sciences Centre London Ontario
The Hospital for Sick Children Toronto Ontario
Montreal Children's Hospital Montreal Quebec
Jim Pattison Children's Hospital Saskatoon Saskatchewan

More University of Calgary trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04902391 on ClinicalTrials.gov ↗ ← All trials in Canada