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

NCT04902391 | Active Not Recruiting DMC

• 1 other identifier: REB20-1825
• Study Type: interventional
• Target: 6,800
• Locations: 1 country
• Sites: 8

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 wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Conditions

Mental Health; Mental Disorders; Pediatrics; Emergency Psychiatric

Keywords

Emergency Psychiatric Services; Healthcare Delivery

Outcome Measures

Primary Outcomes (2)

• Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit

  Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.

  30 days after the index emergency department (ED) visit

• Stirling Children's Wellbeing Scale 30 days after the index ED visit

  Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients \<13 years. Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points. As these scales used for the primary outcomes measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.

  30 days after the index emergency department (ED) visit

Secondary Outcomes (9)

• Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10

  72 hours after the index ED visit

• Quality of life as measured by the Beach Center Family Quality of Life Scale

  30 days after the index ED visit

• Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index ED visit

  90 after the index ED visit

• Stirling Children's Wellbeing Scale at 90 days after the index ED visit

  90 after the index ED visit

• Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index ED visit

  180 days after the index ED visit

Study Arms (2)

Acute Mental Health Care Bundle

EXPERIMENTAL

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.

Other: Health Services

Usual ED-Based Mental Health Care

NO 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.

Interventions

Health Services OTHER

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.

Acute Mental Health Care Bundle

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Brought to the ED under provincial mental health legislation
• 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)

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator
• University of Saskatchewan: collaborator
• University of Manitoba: collaborator
• McMaster University: collaborator
• Western University, Canada: collaborator
• University of Toronto: collaborator
• McGill University: collaborator
• Dalhousie University: collaborator
• Memorial University of Newfoundland: collaborator

Study Sites (8)

The Children's Hospital of Winnipeg

Winnipeg, Manitoba, R3E 0Z3, Canada

Location

Janeway Children's Hospital

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• Rasiah J, Freedman S, Macdonald L, Prisnie K, Eltorki M, Finkelstein Y, Hopkin G, Santana MJ, Thull-Freedman J, Stang A, Prebeg M, Gagnon IJ, Steele M, Mater A, Katz L, Greenfield B, Plotnick L, Monga S, Lipman EL, Wright B, Dimitropoulos G, Porter R, Hurley K, Al Hamarneh YN, Newton A. Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study. BMJ Open. 2022 Jun 17;12(6):e059689. doi: 10.1136/bmjopen-2021-059689.

  PMID: 35715176 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Mental Disorders

Interventions

Health Services

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Stephen Freedman, MDCM, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Amanda Newton, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, parallel arm cluster randomized trial

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: May 26, 2021
• Study Start: February 9, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)