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NCT Number: NCT04902391

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Health Behavior Emergency Psychiatric Mental Disorders Pediatrics Personal Satisfaction Psychological Well-Being

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Winnipeg, Winnipeg, Manitoba, Canada

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 30 days after the index emergency department (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.

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

    Time frame: 30 days after the index emergency department (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.

Secondary outcomes

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

    Time frame: 72 hours after the index ED visit

    Measured in survey completed by the participant using the Service Satisfaction Scale 10 (SSS-10). The scale consists of 12 items (parent version) or 10 items (youth version). Items are scored on a 5-point response scale with a total possible score of 60 (parent) or 50 (youth). Higher scores indicate higher satisfaction.

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

    Time frame: 30 days after the index ED visit

    Measured in survey completed by the participant using the Beach Center Family Quality of Life Scale (FQOL). The 25-item scale uses a 5-point rating with a maximum score of 125 indicating highest quality of life.

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

    Time frame: 90 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.

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

    Time frame: 90 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 the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.

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

    Time frame: 180 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.

  6. Stirling Children's Wellbeing Scale at 180 days after the index ED visit

    Time frame: 180 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 the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.

  7. Median duration of the index ED visits

    Time frame: Hours spent in the ED, measured at the index ED visit (Day 0)

    Measured using data collected in the patient electronic medical record. ED Length of stay is defined as the time interval between triage and discharge

  8. 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

    Time frame: 7 and 30 days after the index ED visit

    Measured using data collected in the patient electronic medical record.

  9. Proportion of emergency department visits for mental healthcare that concluded in hospital admission

    Time frame: Measured based on admissions following the index ED visit (Day 0)

    Measured using data collected in the patient electronic medical record.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Dalhousie University
  • McGill University
  • McMaster University
  • Memorial University of Newfoundland
  • University of Alberta
  • University of Manitoba
  • University of Saskatchewan
  • University of Toronto
  • Western University, Canada

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 26, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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