Evaluation of a mental health care bundle for children in emergency departments
A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle
This study tests a new mental health care package for kids visiting emergency departments to see if it helps them feel better compared to the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6800 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 8 sites (Winnipeg, Manitoba and 7 other locations) |
| Trial ID | NCT04902391 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a co-designed acute mental health care bundle for children and youth seeking emergency department care for mental health and substance use issues. Conducted across eight sites in Canada, the trial compares this care bundle to standard care to determine its impact on patient wellbeing after 30 days. The bundle includes risk assessments, psychosocial evaluations, and a collaborative care approach aimed at improving access to mental health services. The study also seeks to identify barriers and facilitators to implementing this care model effectively.
Who should consider this trial
Good fit: Ideal candidates are children and youth aged 8 to 17.99 years presenting with acute mental health concerns in emergency departments.
Not a fit: Patients brought to the emergency department under mental health legislation or exhibiting severe psychiatric conditions such as schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health outcomes and overall wellbeing of children and youth in emergency settings.
How similar studies have performed: Other studies have shown promise in using similar bundled care approaches for mental health, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Winnipeg, Manitoba and 7 other locations
- The Children's Hospital of Winnipeg — Winnipeg, Manitoba, Canada (Recruiting)
- Janeway Children's Hospital — Saint John's, Newfoundland and Labrador, Canada (Recruiting)
- IWK Health Centre — Halifax, Nova Scotia, Canada (Recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- Montreal Children's Hospital — Montréal, Quebec, Canada (Recruiting)
- Jim Pattison Children's Hospital — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Stephen Freedman, MDCM, MSc — University of Calgary
- Study coordinator: Stephen Freedman, MDCM, MSc
- Email: Stephen.Freedman@ahs.ca
- Phone: 403-955-7749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.