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Mental Health Care Bundle for Pediatric Psychiatric Emergency

Led By Amanda Newton, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 8 to 17.99 years
Be younger than 18 years old
Must not have
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)
Screening 3 weeks
Treatment Varies
Follow Up 180 days after the index ed visit
Awards & highlights


This trial will compare an acute mental health care bundle to standard care in order to determine if it improves wellbeing in children and youth who seek emergency department care for mental health and substance use concerns.

Who is the study for?
This trial is for children and teens aged 8 to nearly 18 who are experiencing a mental health crisis, such as anxiety, behavioral issues, or thoughts of self-harm. They must speak English or French. It's not for those with schizophrenia-like symptoms, significant self-harm requiring medical attention, substance misuse/intoxication, or other serious medical concerns.Check my eligibility
What is being tested?
The study compares an acute mental health care bundle with standard care in emergency departments across Canada. The goal is to see if the new approach better improves wellbeing after 30 days for young people facing mental health and addiction issues.See study design
What are the potential side effects?
Since this trial focuses on health services rather than medication, side effects aren't typical like with drugs. However, there may be emotional or psychological impacts from participating in different types of therapy or interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am between 8 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I, and my parent or guardian, can fluently speak English or French.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days after the index ed visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days after the index ed visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stirling Children's Wellbeing Scale 30 days after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
Secondary outcome measures
Median duration of the index ED visits
Proportion of children and youth that revisited the emergency department for a mental health complaint related to their index emergency department visit within 7 and 30 days of the index visit
Proportion of emergency department visits for mental healthcare that concluded in hospital admission
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Acute Mental Health Care BundleExperimental Treatment1 Intervention
We developed an evidence-based bundle of care to address current gaps in care. The bundle: 1) brings together multiple evidence-based assessment tools (ASQ, HEADS-ED) to ensure efficient, high-value ED-based care; 2) removes barriers to assessment and builds connections to care: Assessments are conducted by a mental health care provider and families have access to urgent follow-up care; and 3) prioritizes family engagement: A shared decision-making framework (Choice and Partnership) is used to promote children and youth as stewards of their care and support partnership between EDs and follow-up services with the duration of care determined collaboratively by the patient and their provider.
Group II: Usual ED-Based Mental Health CareActive Control1 Intervention
Local standards of ED-based mental health care will be delivered at control sites. Site leads have determined that this care does not involve the 3 specific core innovations in the bundle. Local care standards are similar across study sites and include use of CTAS score at triage (but no mental health risk assessment tool), ED physician medical clearance and assessment of consultation need, and no consistent mental health follow-up plan. Sites that are randomized to the control arm will not adopt core bundle elements.

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
312,450 Total Patients Enrolled
Memorial University of NewfoundlandOTHER
69 Previous Clinical Trials
1,829,622 Total Patients Enrolled
Western University, CanadaOTHER
243 Previous Clinical Trials
50,775 Total Patients Enrolled

Media Library

Acute Pediatric Mental Health and Addiction Care Bundle Clinical Trial Eligibility Overview. Trial Name: NCT04902391 — N/A
Mental Illness Research Study Groups: Usual ED-Based Mental Health Care, Acute Mental Health Care Bundle
Mental Illness Clinical Trial 2023: Acute Pediatric Mental Health and Addiction Care Bundle Highlights & Side Effects. Trial Name: NCT04902391 — N/A
Acute Pediatric Mental Health and Addiction Care Bundle 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902391 — N/A
~1611 spots leftby May 2025