← Back to Search

Mental Health Care Bundle for Pediatric Psychiatric Emergency

N/A

Recruiting

Led By Amanda Newton, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 8 to 17.99 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after the index ed visit

Awards & highlights

Study Summary

This trial will compare an acute mental health care bundle to standard care in order to determine if it improves wellbeing in children and youth who seek emergency department care for mental health and substance use concerns.

Who is the study for?

This trial is for children and teens aged 8 to nearly 18 who are experiencing a mental health crisis, such as anxiety, behavioral issues, or thoughts of self-harm. They must speak English or French. It's not for those with schizophrenia-like symptoms, significant self-harm requiring medical attention, substance misuse/intoxication, or other serious medical concerns.Check my eligibility

What is being tested?

The study compares an acute mental health care bundle with standard care in emergency departments across Canada. The goal is to see if the new approach better improves wellbeing after 30 days for young people facing mental health and addiction issues.See study design

What are the potential side effects?

Since this trial focuses on health services rather than medication, side effects aren't typical like with drugs. However, there may be emotional or psychological impacts from participating in different types of therapy or interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours after the index ed visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours after the index ed visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after the index ed visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Median duration of the index ED visits

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

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

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acute Mental Health Care BundleExperimental Treatment1 Intervention

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 II: Usual ED-Based Mental Health CareActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

312,446 Total Patients Enrolled

Memorial University of NewfoundlandOTHER

68 Previous Clinical Trials

1,825,222 Total Patients Enrolled

Western University, CanadaOTHER

239 Previous Clinical Trials

50,653 Total Patients Enrolled

Media Library

Acute Pediatric Mental Health and Addiction Care Bundle Clinical Trial Eligibility Overview. Trial Name: NCT04902391 — N/A

Mental Illness Research Study Groups: Usual ED-Based Mental Health Care, Acute Mental Health Care Bundle

Mental Illness Clinical Trial 2023: Acute Pediatric Mental Health and Addiction Care Bundle Highlights & Side Effects. Trial Name: NCT04902391 — N/A

Acute Pediatric Mental Health and Addiction Care Bundle 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902391 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more opportunities for enrollment in this medical experiment?

"Affirmative. The details on clinicaltrials.gov validate that this research trial is actively enrolling subjects, having been first posted on February 9th 2022 and updated as recently as May 16th 2022. 8 distinct medical sites are working to recruit 6800 patients for the study."

Answered by AI

What criteria must potential participants meet in order to qualify for this clinical trial?

"The enrollment window for this mental health study is open to minors between 8 and 17 years old. Approximately 6800 individuals can be accepted into the trial."

Answered by AI

What is the current size of this medical study's participant pool?

"Right, as indicated by information on clinicaltrials.gov, this research is still sourcing participants to join the trial which was initially posted in February 2022 and updated lastly in May of that year. A total of 6800 individuals are expected at 8 different study sites."

Answered by AI

Recent research and studies

BMJ OpenJournal

Evaluation of Parent and Youth Experiences in Advisory Groups as Part of a Mental Healthcare Clinical Trial: Protocol for a Mixed-method Study

Rasiah, Jananee, Stephen Freedman, Lee Macdonald, Kassi Prisnie, Mohamed Eltorki, Yaron Finkelstein, Gareth Hopkin, et al.. 2022. “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. BMJ. doi:10.1136/bmjopen-2021-059689.

clinicaltrials.govStudy

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

2022. "A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04902391.

All > Mental Illness > Addiction