## Protocol Section
### Identification Module
**NCT ID:** NCT04292379

**Brief Title:** An Innovative Model of Pediatric Acute Mental Health and Addictions Care

**Official Title:** An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System

#### Organization Study ID Info
**ID:** Pro00092862
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
#### Secondary ID Infos
**Domain:** University of Calgary
**ID:** REB19-0357
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2023-01-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-31

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-06-20

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-29

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2020-03-03
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-27
**Study First Submit QC Date:** 2020-02-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Calgary

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alberta

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Mental Health

- Mental Disorders

- Pediatrics

- Emergency Psychiatric

**Keywords:**

- Emergency Psychiatric Services

- Healthcare Delivery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1992

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Other Outcomes

**Description:** Measured using coroner's data

**Measure:** Death by suicide within 30 days of the index ED visit

**Time Frame:** 30 days after the index ED visit

#### Primary Outcomes

**Description:** 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.

**Measure:** Patient wellbeing at 30 days

**Time Frame:** 30 days after the index emergency department (ED) visit

#### Secondary Outcomes

**Description:** 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.

**Measure:** Patient wellbeing at 90 and 180 days

**Time Frame:** 90 days, and 180 days after the index ED visit

**Description:** 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.

**Measure:** Family functioning

**Time Frame:** 30 days after the index ED visit

**Description:** 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.

**Measure:** Satisfaction with acute mental health and addictions ED care

**Time Frame:** 72 hours after the index ED visit

**Description:** Measured using data collected in the patient electronic medical record

**Measure:** 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)

**Description:** 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

**Measure:** 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)

**Description:** Measured using data collected in the patient electronic medical record

**Measure:** 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)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 17 Years

**Minimum Age:** 0 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Patients less than 18 years of age that present to the emergency department with a mental health complaint, and do not require medical clearance by an emergency department physician.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Calgary

**Country:** Canada

**Facility:** Alberta Children's Hospital

**State:** Alberta

**Zip:** T3B 6A8

**Location 2:**

**City:** Edmonton

**Country:** Canada

**Facility:** Stollery Children's Hospital

**State:** Alberta

**Zip:** T6G 2B7

#### Overall Officials

**Official 1:**

**Affiliation:** University of Alberta

**Name:** Amanda Newton, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** IPD will not be shared with other researchers.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Freedman 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.

**PMID:** 33318032

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Mental Disorders

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M19100

- Name: Behavior, Addictive

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

- ID: D000001523

- Term: Mental Disorders

### Misc Info Module

- Version Holder: 2024-05-24
