Status:
ACTIVE_NOT_RECRUITING
A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of Alberta
University of Saskatchewan
Conditions:
Mental Health
Mental Disorders
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief 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 wellbein...
Detailed Description
The investigators we co-designed, with parents and youth, an acute mental health care bundle-a set of evidence informed practices collectively used to improve the quality of care. The bundle of care i...
Eligibility Criteria
Inclusion
- Age 8 to 17.99 years
- Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
- Anxiety/situational crisis and/or hyperventilation
- Bizarre/paranoid behaviour
- Concern for patient's welfare
- Depression/suicidal/deliberate self-harm
- Hallucinations/delusions
- Violent/homicidal behaviour
- Insomnia
- Pediatric disruptive behaviour
Exclusion
- Brought to the ED under provincial mental health legislation
- Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion)
- Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.)
- 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.)
- Substance misuse/intoxication or altered level of consciousness
- Exhibiting a behavioural syndrome associated with physiologic disturbances (e.g., anorexia)
- Children/youth will also be excluded based on language barriers:
- Language barrier (i.e., patient and parent/legal guardian must be fluent in either English or French)
Key Trial Info
Start Date :
February 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
6800 Patients enrolled
Trial Details
Trial ID
NCT04902391
Start Date
February 9 2022
End Date
December 31 2025
Last Update
July 17 2025
Active Locations (8)
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1
The Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3E 0Z3
2
Janeway Children's Hospital
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
3
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
4
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5