Mental HealthNCT04292379
An Innovative Model of Pediatric Acute Mental Health and Addictions Care
A study testing Care Bundle in people with Mental Health and Mental Disorders, run by University of Alberta at 2 sites in Canada.
Trial summary
The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Mental Health, Mental Disorders, Pediatrics
- What is being tested?
- Care Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,992 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Jan 2020to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is under 18 years of age
- Patient came to the emergency department with a mental health and/or addiction concern
- Patient presented with one of the following CEDIS complaints:
- Anxiety, bizarre behaviour, concern for patient's welfare, deliberate self-harm, depression/suicidal, homicidal behaviour, insomnia, pediatric disruptive behaviour, situational crisis, violent behaviour
Who cannot join
- Brought to the ED by police, peace officer or EMS?
- Held under Form 10
- Features of schizophrenia, schizotypal and delusional disorders (e.g., hallucinations, delusions, active psychosis)
- Behavioural syndromes or other medical concerns requiring medical clearance (e.g., eating disorders)
- Significant self-harm requiring medical clearance (e.g., deep laceration, ingestion, hanging)
- Barriers to communication at triage (e.g., language)
- Previous participation in the study
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
About this study
Official title: An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System
The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.
Read the detailed description
The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, emergency mental health and addictions care. This care bundle will provide high value to families, matching resources and services to need while eliminating healthcare inefficiencies and closing care gaps. The bundle will introduce two well-established tools for healthcare providers to use in EDs, walk-in clinics, and urgent mental health care appointments. These tools are the 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).
The bundle will also introduce new processes to improve healthcare system efficiencies, navigation and transitions between healthcare sectors. For families who receive care in the ED, the investigators will remove the physician gatekeeper role so that children/youth who are screened as low-risk will be offered a follow-up appointment in an urgent mental health care clinic within 24-48 hours. Those who screen as high-risk will see a mental health specialist and undergo a HEADS-ED assessment. Families who follow up in the clinic will receive care that applies a Choice And Partnership Approach (CAPA). CAPA is a collaborative approach to healthcare, where healthcare providers work in partnership with children/youth and their parents to identify choices for care that best match individual needs and preferences.
Study Goal: The investigators' goal is the right care, with the right people, at the right place and time.
Study Design: To measure the bundle's impact, the investigators will use an interrupted time series (ITS) design.
- Conditions
- Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric
- Being tested
- Standard care, Care Bundle
- Keywords
- Emergency Psychiatric Services, Healthcare Delivery
- Medical subject headings
- Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Standard procedures and assessments
Care BundleOther
Suicide risk screening tool, mental health assessment tool, follow-up appointment
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Mental health visits involve an assessment by a triage nurse who classifies visit urgency into one of five acuity levels using the Canadian Triage and Acuity Scale (CTAS) score. Following triage, children could be assessed by a range of health care providers: emergency department nurse, emergency department physician, mental health nurse, and/or a child and adolescent psychiatrist. Standardized tools are not typically used to guide assessments. Most discharge instructions require families to organize the child's follow-up care. Receives: Other: Standard care |
| Care Bundle | Experimental | The bundle standardized suicide risk screening at triage, introduced a focused mental health assessment to guide discussions across health care providers, and included a booked follow-up appointment after the emergency department visit. Receives: Other: Care Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient wellbeing at 30 days
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥14 years of age, and the Stirling Children's Wellbeing Scale (SCWBS) for patients <14 years of age.
For the WEMWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.
For the SCWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.
Measured: 30 days after the index emergency department (ED) visit
Secondary outcomes (6)
Patient wellbeing at 90 and 180 days
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥14 years of age, and the Stirling Children's Wellbeing Scale (SCWBS) for patients <14 years of age.
For the WEMWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.
For the SCWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.
Measured: 90 days, and 180 days after the index ED visit
Family functioning
Measured in survey completed by the participant using the 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.
Measured: 30 days after the index ED visit
Satisfaction with acute mental health and addictions ED care
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.
Measured: 72 hours after the index ED visit
Proportion of children/youth admitted to child mental health service (child and adolescent psychiatry, mental health team, etc.)
Measured using data collected in the patient electronic medical record
Measured: Index ED visit (Day 0)
Length of ED stay for discharged patients with any mental health presenting complaint
Measured using data collected in the patient electronic medical record. ED Length of stay is defined as the time between patient triage and discharge from the emergency department
Measured: Hours spent in the ED, measured at the index ED visit (Day 0)
Proportion of ED revisits within 72 hours and 30 days for mental health and substance use disorders
Measured using data collected in the patient electronic medical record
Measured: 72 hours and 30 days after the index ED visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start29 Jan 2020
- Primary completion20 Jun 2022
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a quasi-experimental study design conducted in three phases. Phase 1 involves standard care. Phase 2 involves introducing a new care bundle to clinical practice using quality improvement and change management strategies. Phase 3 involves delivery of the care bundle.
- Masking
- None (open label)
- Enrolment
- 1,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Amanda Newton, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292379
- Sponsor's protocol ID
- Pro00092862
- Other IDs
- REB19-0357
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2020
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Newton AS, Thull-Freedman J, Xie J, Lightbody T, Woods J, Stang A, Winston K, Larson J, Wright B, Stubbs M, Morrissette M, Freedman SB; Pediatric Emergency Research Canada (PERC). Outcomes Following a Mental Health Care Intervention for Children in the Emergency Department: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461972. doi: 10.1001/jamanetworkopen.2024.61972.
PubMed 40009377Freedman S, Thull-Freedman J, Lightbody T, Prisnie K, Wright B, Coulombe A, Anderson LM, Stang AS, Mikrogianakis A, VanRiper L, Stubbs M, Newton A; Pediatric Emergency Research Canada (PERC). Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. BMJ Open Qual. 2020 Dec;9(4):e001106. doi: 10.1136/bmjoq-2020-001106.
PubMed 33318032
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System
- ClinicalTrials.gov ID
- NCT04292379
- Acronym / sponsor ID
- Pro00092862
- Conditions
- Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric
- Keywords
- Emergency Psychiatric Services, Healthcare Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,992 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.
Detailed description
The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, emergency mental health and addictions care. This care bundle will provide high value to families, matching resources and services to need while eliminating healthcare inefficiencies and closing care gaps. The bundle will introduce two well-established tools for healthcare providers to use in EDs, walk-in clinics, and urgent mental health care appointments. These tools are the 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).
The bundle will also introduce new processes to improve healthcare system efficiencies, navigation and transitions between healthcare sectors. For families who receive care in the ED, the investigators will remove the physician gatekeeper role so that children/youth who are screened as low-risk will be offered a follow-up appointment in an urgent mental health care clinic within 24-48 hours. Those who screen as high-risk will see a mental health specialist and undergo a HEADS-ED assessment. Families who follow up in the clinic will receive care that applies a Choice And Partnership Approach (CAPA). CAPA is a collaborative approach to healthcare, where healthcare providers work in partnership with children/youth and their parents to identify choices for care that best match individual needs and preferences.
Study Goal: The investigators' goal is the right care, with the right people, at the right place and time.
Study Design: To measure the bundle's impact, the investigators will use an interrupted time series (ITS) design.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental study design conducted in three phases. Phase 1 involves standard care. Phase 2 involves introducing a new care bundle to clinical practice using quality improvement and change management strategies. Phase 3 involves delivery of the care bundle.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard careMental health visits involve an assessment by a triage nurse who classifies visit urgency into one of five acuity levels using the Canadian Triage and Acuity Scale (CTAS) score. Following triage, children could be assessed by a range of health care providers: emergency department nurse, emergency department physician, mental health nurse, and/or a child and adolescent psychiatrist. Standardized tools are not typically used to guide assessments. Most discharge instructions require families to organize the child's follow-up care. |
| Care Bundle | Experimental | Other: Care BundleThe bundle standardized suicide risk screening at triage, introduced a focused mental health assessment to guide discussions across health care providers, and included a booked follow-up appointment after the emergency department visit. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient is under 18 years of age
- Patient came to the emergency department with a mental health and/or addiction concern
- Patient presented with one of the following CEDIS complaints:
- Anxiety, bizarre behaviour, concern for patient's welfare, deliberate self-harm, depression/suicidal, homicidal behaviour, insomnia, pediatric disruptive behaviour, situational crisis, violent behaviour
Key exclusion criteria (7 listed)
- Brought to the ED by police, peace officer or EMS?
- Held under Form 10
- Features of schizophrenia, schizotypal and delusional disorders (e.g., hallucinations, delusions, active psychosis)
- Behavioural syndromes or other medical concerns requiring medical clearance (e.g., eating disorders)
- Significant self-harm requiring medical clearance (e.g., deep laceration, ingestion, hanging)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careStandard procedures and assessments | Other | Standard care |
| Care BundleSuicide risk screening tool, mental health assessment tool, follow-up appointment | Other | Care Bundle |
Primary outcome
Patient wellbeing at 30 days
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 ≥14 years of age, and the Stirling Children's Wellbeing Scale (SCWBS) for patients <14 years of age. For the WEMWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points. For the SCWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.
6 secondary outcomes
Patient wellbeing at 90 and 180 days
Time frame: 90 days, and 180 days after the index ED visit
Family functioning
Time frame: 30 days after the index ED visit
Satisfaction with acute mental health and addictions ED care
Time frame: 72 hours after the index ED visit
Proportion of children/youth admitted to child mental health service (child and adolescent psychiatry, mental health team, etc.)
Time frame: Index ED visit (Day 0)
Length of ED stay for discharged patients with any mental health presenting complaint
Time frame: Hours spent in the ED, measured at the index ED visit (Day 0)
Proportion of ED revisits within 72 hours and 30 days for mental health and substance use disorders
Time frame: 72 hours and 30 days after the index ED visit (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 40009377Newton AS, Thull-Freedman J, Xie J, Lightbody T, Woods J, Stang A, Winston K, Larson J, Wright B, Stubbs M, Morrissette M, Freedman SB; Pediatric Emergency Research Canada (PERC). Outcomes Following a Mental Health Care Intervention for Children in the Emergency Department: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461972. doi: 10.1001/jamanetworkopen.2024.61972.
- Derived from this study: PubMed 33318032Freedman S, Thull-Freedman J, Lightbody T, Prisnie K, Wright B, Coulombe A, Anderson LM, Stang AS, Mikrogianakis A, VanRiper L, Stubbs M, Newton A; Pediatric Emergency Research Canada (PERC). Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. BMJ Open Qual. 2020 Dec;9(4):e001106. doi: 10.1136/bmjoq-2020-001106.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Newton, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Bundle in people with Mental Health and Mental Disorders, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient wellbeing at 30 days (time frame: 30 days after the index emergency department (ED) visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292379, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.