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

NCT ID: NCT04902391

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2025-12-31

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.

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 includes:

1. Triage-based evaluation of risk for suicide [Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education & Employment; Activities & Peers; Drugs & Alcohol; Suicidality; Emotions & Behaviours; Discharge or Current Resources]

2. Focused mental health team psychosocial evaluation to guide decision-making

3. Choice And Partnership Approach (CAPA) to care

This bundle of care also strives to remove the ED physician as the gatekeeper to mental health care and will facilitate, ideally, 24-48 hour urgent mental health follow-up (booked before the child/family leave the ED), with up to 96 hours to coordinate follow-up for patients attending the ED on weekends.

Primary Research Objective: To determine, in an 8-site, hybrid Type I 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 ED care for mental health and substance use concerns.

Secondary Research Objectives: (1) To determine if the bundle improves wellbeing, satisfaction with care, family functioning, and health care delivery; (2) To identify modifiable barriers, constraints, and enablers of bundle implementation fidelity and effectiveness; (3) To test if trial intervention effects are moderated by sociodemographic characteristics (sex, gender, ethnicity, culture, education, and socioeconomic status); and (4) To assess the cost-effectiveness of the approach.

Conditions

Mental Health; Mental Disorders; Pediatrics; Emergency Psychiatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Acute Mental Health Care Bundle

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 Type: EXPERIMENTAL

Health Services

Intervention Type: 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.

Usual ED-Based Mental Health Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Services

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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Freedman, MDCM, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Amanda Newton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

The Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Janeway Children's Hospital

St. John's, Newfoundland and Labrador, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35715176 (View on PubMed)

Other Identifiers

REB20-1825

Identifier Type: -

Identifier Source: org_study_id