A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Men… (NCT04902391) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle
Canada6,800 participantsStarted 2022-02-09
Plain-language 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.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion criteria
✓. Age 8 to 17.99 years
✓. Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
✕. 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
What they're measuring
1
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
Timeframe: 30 days after the index emergency department (ED) visit
2
Stirling Children's Wellbeing Scale 30 days after the index ED visit
Timeframe: 30 days after the index emergency department (ED) visit